A Clinical Study of the Comfilcon A Asphere Soft Contact Lens in Users of Digital Devices

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04067050
• Collaborator: (none)
• Enrollment: 61
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.9
• Patients Per Site Per Month: 6.9

Study Details

Study Description

Brief Summary

The aim of this work is to investigate the clinical performance and subjective acceptance of the comfilcon A asphere contact lens when compared to single-vision spectacles in subjects who have never worn contact lenses and who use digital devices (such as phones, tablets, laptops, desktop computers) for at least 4 hours per day on at least 5 days per week.

Condition or Disease	Intervention/Treatment	Phase
Ametropia	Device: comfilcon A asphere; Device: Spectacles	N/A

Detailed Description

The aim of this clinical work is to compare the clinical performance and subjective acceptance of comfilcon A asphere contact lens when compared to single-vision spectacles in subjects who use digital devices (phones, tablets, laptops, desktop computers) for at least 4 hours per day on at least 5 days per week. Subjects will be randomized to use either their habitual spectacles or the study contact lenses for two months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Clinical Study of the Biofinity Energys Soft Contact Lens in Users of Digital Devices
• Actual Study Start Date: Jul 4, 2019
• Actual Primary Completion Date: Feb 28, 2020
• Actual Study Completion Date: Mar 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: comfilcon A asphere Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week.	Device: comfilcon A asphere; Contact Lens; Other Names: test
Active Comparator: Habitual Spectacles Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week.	Device: Spectacles; Habitual spectacles; Other Names: Control Single Vision Spectacles

Outcome Measures

Primary Outcome Measures

1. Symptom of Burning [Baseline]

   Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

2. Symptom of Burning [1 month]

   Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

3. Symptom of Burning [2 months]

   Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

4. Symptom of Itching [Baseline]

   Symptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

5. Symptom of Itching [One Month]

   Symptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

6. Symptom of Itching [Two Months]

   Symptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

7. Symptom of Feeling of Foreign Body [Baseline]

   Symptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

8. Symptom of Feeling of Foreign Body [One Month]

   Symptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

9. Symptom of Feeling of Foreign Body [Two Months]

   Symptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

10. Symptom of Tearing [Baseline]

    Symptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

11. Symptom of Tearing [One Month]

    Symptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

12. Symptom of Tearing [Two Months]

    Symptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

13. Symptom of Excessive Blinking [Baseline]

    Symptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

14. Symptom of Excessive Blinking [One Month]

    Symptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

15. Symptom of Excessive Blinking [Two Months]

    Symptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

16. Symptom of Eye Redness [Baseline]

    Symptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

17. Symptom of Eye Redness [One Month]

    Symptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

18. Symptom of Eye Redness [Two Months]

    Symptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

19. Symptom of Eye Pain [Baseline]

    Symptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

20. Symptom of Eye Pain [One Month]

    Symptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

21. Symptom of Eye Pain [Two Months]

    Symptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

22. Symptom of Heavy Eyelids [Baseline]

    Symptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

23. Symptom of Heavy Eyelids [One Month]

    Symptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

24. Symptom of Heavy Eyelids [Two Months]

    Symptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

25. Symptom of Dryness [Baseline]

    Symptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

26. Symptom of Dryness [One Month]

    Symptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

27. Symptom of Dryness [Two Months]

    Symptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

28. Symptom of Blurred Vision [Baseline]

    Symptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

29. Symptom of Blurred Vision [One Month]

    Symptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

30. Symptom of Blurred Vision [Two Months]

    Symptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

31. Symptom of Double Vision [Baseline]

    Symptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

32. Symptom of Double Vision [One Month]

    Symptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

33. Symptom of Double Vision [Two Months]

    Symptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

34. Symptom of Difficulty Focusing For Near Vision [Baseline]

    Symptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

35. Symptom of Difficulty Focusing For Near Vision [One Month]

    Symptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

36. Symptom of Difficulty Focusing For Near Vision [Two Months]

    Symptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

37. Symptom of Increased Sensitivity to Light [Baseline]

    Symptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

38. Symptom of Increased Sensitivity to Light [One Month]

    Symptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

39. Symptom of Increased Sensitivity to Light [Two Months]

    Symptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

40. Symptom of Colored Haloes Around Objects [Baseline]

    Symptom of colored haloes around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

41. Symptom of Colored Haloes Around Objects [One Month]

    Symptom of colored haloes around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

42. Symptom of Colored Halos Around Objects [Two Months]

    Symptom of colored halos around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

43. Symptom of Feeling That Sight is Worsening [Baseline]

    Symptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

44. Symptom of Feeling That Sight is Worsening [One Month]

    Symptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

45. Symptom of Feeling That Sight is Worsening [Two Months]

    Symptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

46. Symptom of Headache [Baseline]

    Symptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

47. Symptom of Headache [One Month]

    Symptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

48. Symptom of Headache [Two Months]

    Symptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• They are between 18 and 35 years of age (inclusive).

• They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.

• They are willing and able to follow the protocol.

• They are a 'neophyte' (i.e. someone who has not worn contact lenses previously, with the exception for the purposes of a trial fitting, lasting up to one week).

• They have a contact lens spherical prescription between -1.00 to -6.25D (inclusive) based on the ocular refraction.

• They have a cylindrical correction of -0.875DC or less in each eye based on the ocular refraction

• They own and habitually wear single vision spectacles used for both distance and near vision, including computer and digital device use.

• Their single vision spectacles have a mean sphere equivalent within ±0.50D of that of the refraction found in the study for each eye (after having taken lens effectivity into account).

• They are willing to be fitted with contact lenses and understand they may be randomized to either group.

• They are willing to wear the contact lenses (if relevant) or spectacles for at least 8 hours per day, 5 days per week.

• They typically use digital devices for a minimum of 4 hours per day, 5 days per week.

• They agree not to change the spectacles they will wear for digital device use for the duration of the study.

• They agree not to participate in other clinical research for the duration of the study.

Exclusion Criteria:

• They have an ocular disorder which would normally contra-indicate contact lens wear.

• They have a systemic disorder which would normally contra-indicate contact lens wear.

• They are using any topical medication such as eye drops (including comfort drops) or ointment on a regular basis.

• The spectacles they use for digital device viewing on the study have been made with specialist features for computer use, digital eye fatigue or are multifocal/bifocal.

• They are aphakic.

• They have had corneal refractive surgery.

• They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

• They are pregnant or breastfeeding.

• They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.

• They have evidence of a heterotropia or decompensating heterotropia on cover test.

• They have a history of having been prescribed prism in their spectacles (by self report).

• They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eurolens Research - The University of Manchester	Manchester		United Kingdom	M13 9PL

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 3, 2019

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT04067050
• Other Study ID Numbers: EX-MKTG-105
• First Posted: Aug 26, 2019
• Last Update Posted: Apr 13, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Period Title: One Month
STARTED	32	29
COMPLETED	28	29
NOT COMPLETED	4	0
Period Title: One Month
STARTED	22	29
COMPLETED	20	29
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles	Total
Arm/Group Description	Subjects were randomized to use the study contact lenses for two months.	Subjects were randomized to wear habitual spectacles for two months.	Total of all reporting groups
Overall Participants	32	29	61
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	32 100%	29 100%	61 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	24.4 (3.9)	22.9 (4.4)	23.7 (4.2)
Sex: Female, Male (Count of Participants)
Female	20 62.5%	18 62.1%	38 62.3%
Male	12 37.5%	11 37.9%	23 37.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United Kingdom	32 100%	29 100%	61 100%

Outcome Measures

1. Primary Outcome

Title	Symptom of Burning
Description	Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Intensity of symptom of burning was measured only for subjects who had frequency of symptom of burning on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	32	29
Frequency	0.16 (0.37)	0.21 (0.49)
Intensity	1.00 (0.00)	1.00 (0.00)

2. Primary Outcome

Title	Symptom of Burning
Description	Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

One subject scores was not measured for Habitual spectacles group. Intensity of symptom of burning was measured only for subjects who had frequency of symptom of burning on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	28	28
Frequency	0.11 (0.31)	0.29 (0.53)
Intensity	1.00 (0.00)	1.14 (0.38)

3. Primary Outcome

Title	Symptom of Burning
Description	Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	2 months

Outcome Measure Data

Analysis Population Description

Intensity of symptom of burning was measured only for subjects who had frequency of symptom of burning on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	20	29
Frequency	0.00 (0.00)	0.17 (0.38)
Intensity	1.00 (0.00)

4. Primary Outcome

Title	Symptom of Itching
Description	Symptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Intensity of itching was measured only for subjects who had frequency of itching on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	32	29
Frequency	0.41 (0.56)	0.52 (0.57)
Intensity	1.08 (0.29)	1.00 (0.00)

5. Primary Outcome

Title	Symptom of Itching
Description	Symptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

One subject score was not measured for Habitual spectacles group. Intensity of itching was measured only for subjects who had frequency of itching on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	28	28
Frequency	0.68 (0.55)	0.36 (0.56)
Intensity	1.00 (0.00)	1.00 (0.00)

6. Primary Outcome

Title	Symptom of Itching
Description	Symptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Two Months

Outcome Measure Data

Analysis Population Description

Intensity of itching was measured only for subjects who had frequency of itching on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	20	29
Frequency	0.45 (0.51)	0.41 (0.50)
Intensity	1.00 (0.00)	1.00 (0.00)

7. Primary Outcome

Title	Symptom of Feeling of Foreign Body
Description	Symptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Intensity of feeling of foreign body was measured only for subjects who had frequency of feeling of foreign body on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	32	29
Frequency	0.19 (0.40)	0.17 (0.38)
Intensity	1.33 (0.52)	1.20 (0.45)

8. Primary Outcome

Title	Symptom of Feeling of Foreign Body
Description	Symptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

One subject score was not measured for Habitual spectacles group. Intensity of feeling of foreign body was measured only for subjects who had frequency of feeling of foreign body on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	28	28
Frequency	0.75 (0.59)	0.11 (0.31)
Intensity	1.00 (0.00)	1.00 (0.00)

9. Primary Outcome

Title	Symptom of Feeling of Foreign Body
Description	Symptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Two Months

Outcome Measure Data

Analysis Population Description

Intensity of feeling of foreign body was measured only for subjects who had frequency of feeling of foreign body on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	20	29
Frequency	0.50 (0.61)	0.21 (0.41)
Intensity	1.00 (0.00)	1.00 (0.00)

10. Primary Outcome

Title	Symptom of Tearing
Description	Symptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Intensity of symptom of tearing was measured only for subjects who had frequency of symptom of tearing on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	32	29
Frequency	0.53 (0.51)	0.43 (0.63)
Intensity	1.06 (0.24)	1.18 (0.40)

11. Primary Outcome

Title	Symptom of Tearing
Description	Symptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

One subject score was not measured for Habitual spectacles group. Intensity of symptom of tearing was measured only for subjects who had frequency of symptom of tearing on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	28	28
Frequency	0.39 (0.57)	0.33 (0.48)
Intensity	1.00 (0.00)	1.10 (0.32)

12. Primary Outcome

Title	Symptom of Tearing
Description	Symptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Two Months

Outcome Measure Data

Analysis Population Description

Intensity of symptom of tearing was measured only for subjects who had frequency of symptom of tearing on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	20	29
Frequency	0.35 (0.49)	0.45 (0.57)
Intensity	1.00 (0.00)	1.08 (0.29)

13. Primary Outcome

Title	Symptom of Excessive Blinking
Description	Symptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Intensity of symptom of excessive blinking was measured only for subjects who had frequency of symptom of excessive blinking on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	32	29
Frequency	0.25 (0.51)	0.38 (0.56)
Intensity	1.00 (0.00)	1.10 (0.32)

14. Primary Outcome

Title	Symptom of Excessive Blinking
Description	Symptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

One subject score was not measured for Habitual spectacles group. Intensity of symptom of excessive blinking was measured only for subjects who had frequency of symptom of excessive blinking on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	28	28
Frequency	0.46 (0.51)	0.29 (0.53)
Intensity	1.00 (0.00)	1.14 (0.38)

15. Primary Outcome

Title	Symptom of Excessive Blinking
Description	Symptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Two Months

Outcome Measure Data

Analysis Population Description

Intensity of symptom of excessive blinking was measured only for subjects who had frequency of symptom of excessive blinking on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	20	29
Frequency	0.35 (0.49)	0.17 (0.38)
Intensity	1.00 (0.00)	1.20 (0.45)

16. Primary Outcome

Title	Symptom of Eye Redness
Description	Symptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Intensity of symptom of eye redness was measured only for subjects who had frequency of symptom of eye redness on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	32	29
Frequency	0.28 (0.46)	0.21 (0.41)
Intensity	1.11 (0.33)	1.00 (0.00)

17. Primary Outcome

Title	Symptom of Eye Redness
Description	Symptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

One subject score was not measured for Habitual spectacles group. Intensity of symptom of eye redness was measured only for subjects who had frequency of symptom of eye redness on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	28	28
Frequency	0.36 (0.56)	0.18 (0.39)
Intensity	1.00 (0.00)	1.00 (0.00)

18. Primary Outcome

Title	Symptom of Eye Redness
Description	Symptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Two Months

Outcome Measure Data

Analysis Population Description

Intensity of symptom of eye redness was measured only for subjects who had frequency of symptom of eye redness on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	20	29
Frequency	0.20 (0.41)	0.24 (0.44)
Intensity	1.00 (0.00)	1.00 (0.00)

19. Primary Outcome

Title	Symptom of Eye Pain
Description	Symptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Intensity of symptom of eye pain was measured only for subjects who had frequency of symptom of eye pain on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	32	29
Frequency	0.34 (0.55)	0.34 (0.61)
Intensity	1.10 (0.32)	1.13 (0.35)

20. Primary Outcome

Title	Symptom of Eye Pain
Description	Symptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

One subject score was not measured for Habitual spectacles group. Intensity of symptom of eye pain was measured only for subjects who had frequency of symptom of eye pain on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	28	28
Frequency	0.14 (0.36)	0.25 (0.44)
Intensity	1.00 (0.00)	1.00 (0.00)

21. Primary Outcome

Title	Symptom of Eye Pain
Description	Symptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Two Months

Outcome Measure Data

Analysis Population Description

Intensity of symptom of eye pain was measured only for subjects who had frequency of symptom of eye pain on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	20	29
Frequency	0.00 (0.00)	0.31 (0.54)
Intensity	1.00 (0.00)

22. Primary Outcome

Title	Symptom of Heavy Eyelids
Description	Symptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Intensity of symptom of heavy eyelids was measured only for subjects who had frequency of symptom of heavy eyelids on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	32	29
Frequency	0.56 (0.62)	0.45 (0.51)
Intensity	1.13 (0.34)	1.00 (0.00)

23. Primary Outcome

Title	Symptom of Heavy Eyelids
Description	Symptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

One subject score was not measured for Habitual spectacles group. Intensity of symptom of heavy eyelids was measured only for subjects who had frequency of symptom of heavy eyelids on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	28	28
Frequency	0.39 (0.50)	0.46 (0.58)
Intensity	1.00 (0.00)	1.17 (0.39)

24. Primary Outcome

Title	Symptom of Heavy Eyelids
Description	Symptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Two Months

Outcome Measure Data

Analysis Population Description

Intensity of symptom of heavy eyelids was measured only for subjects who had frequency of symptom of heavy eyelids on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	20	29
Frequency	0.35 (0.49)	0.48 (0.63)
Intensity	1.00 (0.00)	1.08 (0.29)

25. Primary Outcome

Title	Symptom of Dryness
Description	Symptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Intensity of symptom of dryness was measured only for subjects who had frequency of symptom of dryness on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	32	29
Frequency	0.38 (0.55)	0.48 (0.51)
Intensity	1.18 (0.40)	1.00 (0.00)

26. Primary Outcome

Title	Symptom of Dryness
Description	Symptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

One subject score was not measured for Habitual spectacles group. Intensity of symptom of dryness was measured only for subjects who had frequency of symptom of dryness on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	28	28
Frequency	0.75 (0.70)	0.43 (0.50)
Intensity	1.06 (0.24)	1.00 (0.00)

27. Primary Outcome

Title	Symptom of Dryness
Description	Symptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Two Months

Outcome Measure Data

Analysis Population Description

Intensity of symptom of dryness was measured only for subjects who had frequency of symptom of dryness on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	20	29
Frequency	0.75 (0.55)	0.48 (0.57)
Intensity	1.07 (0.27)	1.15 (0.38)

28. Primary Outcome

Title	Symptom of Blurred Vision
Description	Symptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Intensity of symptom of blurred vision was measured only for subjects who had frequency of symptom of blurred vision on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	32	29
Frequency	0.34 (0.48)	0.45 (0.51)
Intensity	1.00 (0.00)	1.00 (0.00)

29. Primary Outcome

Title	Symptom of Blurred Vision
Description	Symptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

One subject score was not measured for Habitual spectacles group. Intensity of symptom of blurred vision was measured only for subjects who had frequency of symptom of blurred vision on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	28	28
Frequency	0.54 (0.58)	0.25 (0.44)
Intensity	1.00 (0.00)	1.14 (0.38)

30. Primary Outcome

Title	Symptom of Blurred Vision
Description	Symptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Two Months

Outcome Measure Data

Analysis Population Description

Intensity of symptom of blurred vision was measured only for subjects who had frequency of symptom of blurred vision on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	20	29
Frequency	0.35 (0.49)	0.28 (0.45)
Intensity	1.00 (0.00)	1.00 (0.00)

31. Primary Outcome

Title	Symptom of Double Vision
Description	Symptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Intensity of symptom of double vision was measured only for subjects who had frequency of symptom of double vision on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	32	29
Frequency	0.06 (0.25)	0.07 (0.37)
Intensity	1.00 (0.00)	1.00 (0.00)

32. Primary Outcome

Title	Symptom of Double Vision
Description	Symptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

One subject score was not measured for Habitual spectacles group. Intensity of symptom of double vision was measured only for subjects who had frequency of symptom of double vision on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	28	28
Frequency	0.11 (0.31)	0.07 (0.26)
Intensity	1.00 (0.00)	1.00 (0.00)

33. Primary Outcome

Title	Symptom of Double Vision
Description	Symptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Two Months

Outcome Measure Data

Analysis Population Description

Intensity of symptom of double vision was measured only for subjects who had frequency of symptom of double vision on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	20	29
Frequency	0.05 (0.22)	0.07 (0.26)
Intensity	1.00 (0.00)	1.00 (0.00)

34. Primary Outcome

Title	Symptom of Difficulty Focusing For Near Vision
Description	Symptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Intensity of symptom of difficulty focusing for near vision was measured only for subjects who had frequency of symptom of difficulty focusing for near vision on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	32	29
Frequency	0.28 (0.46)	0.41 (0.57)
Intensity	1.10 (0.32)	1.00 (0.00)

35. Primary Outcome

Title	Symptom of Difficulty Focusing For Near Vision
Description	Symptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

One subject score was not measured for Habitual spectacles group. Intensity of symptom of difficulty focusing for near vision was measured only for subjects who had frequency of symptom of difficulty focusing for near vision on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	28	28
Frequency	0.18 (0.39)	0.29 (0.46)
Intensity	1.00 (0.00)	1.00 (0.00)

36. Primary Outcome

Title	Symptom of Difficulty Focusing For Near Vision
Description	Symptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Two Months

Outcome Measure Data

Analysis Population Description

Intensity of symptom of difficulty focusing for near vision was measured only for subjects who had frequency of symptom of difficulty focusing for near vision on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	20	29
Frequency	0.45 (0.51)	0.14 (0.35)
Intensity	1.00 (0.00)	1.00 (0.00)

37. Primary Outcome

Title	Symptom of Increased Sensitivity to Light
Description	Symptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Intensity of symptom of increased sensitivity to light was measured only for subjects who had frequency of symptom of increased sensitivity to light on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	32	29
Frequency	0.59 (0.67)	0.48 (0.63)
Intensity	1.19 (0.40)	1.17 (0.39)

38. Primary Outcome

Title	Symptom of Increased Sensitivity to Light
Description	Symptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

One subject score was not measured for Habitual spectacles group. Intensity of symptom of increased sensitivity to light was measured only for subjects who had frequency of symptom of increased sensitivity to light on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	28	28
Frequency	0.25 (0.44)	0.36 (0.62)
Intensity	1.00 (0.00)	1.13 (0.35)

39. Primary Outcome

Title	Symptom of Increased Sensitivity to Light
Description	Symptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Two Months

Outcome Measure Data

Analysis Population Description

Intensity of symptom of increased sensitivity to light was measured only for subjects who had frequency of symptom of increased sensitivity to light on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	20	29
Frequency	0.10 (0.31)	0.24 (0.44)
Intensity	1.00 (0.00)	1.14 (0.38)

40. Primary Outcome

Title	Symptom of Colored Haloes Around Objects
Description	Symptom of colored haloes around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Intensity of symptom of colored haloes around objects was measured only for subjects who had frequency of symptom of colored haloes around objects on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	32	29
Frequency	0.16 (0.45)	0.17 (0.47)
Intensity	1.25 (0.50)	1.00 (0.00)

41. Primary Outcome

Title	Symptom of Colored Haloes Around Objects
Description	Symptom of colored haloes around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

One subject score was not measured for Habitual spectacles group. Intensity of symptom of colored haloes around objects was measured only for subjects who had frequency of symptom of colored haloes around objects on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	28	28
Frequency	0.11 (0.31)	0.07 (0.26)
Intensity	1.00 (0.00)	1.00 (0.00)

42. Primary Outcome

Title	Symptom of Colored Halos Around Objects
Description	Symptom of colored halos around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Two Months

Outcome Measure Data

Analysis Population Description

Intensity of symptom of colored haloes around objects was measured only for subjects who had frequency of symptom of colored haloes around objects on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	20	29
Frequency	0.10 (0.31)	0.07 (0.26)
Intensity	1.00 (0.00)	1.00 (0.00)

43. Primary Outcome

Title	Symptom of Feeling That Sight is Worsening
Description	Symptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Intensity of symptom of feeling that sight is worsening was measured only for subjects who had frequency of symptom of feeling that sight is worsening on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	32	28
Frequency	0.34 (0.60)	0.48 (0.51)
Intensity	1.00 (0.00)	1.07 (0.27)

44. Primary Outcome

Title	Symptom of Feeling That Sight is Worsening
Description	Symptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

One subject score was not measured for Habitual spectacles group. Intensity of symptom of feeling that sight is worsening was measured only for subjects who had frequency of symptom of feeling that sight is worsening on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	28	28
Frequency	0.25 (0.44)	0.36 (0.49)
Intensity	1.00 (0.00)	1.10 (0.32)

45. Primary Outcome

Title	Symptom of Feeling That Sight is Worsening
Description	Symptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Two Months

Outcome Measure Data

Analysis Population Description

Intensity of symptom of feeling that sight is worsening was measured only for subjects who had frequency of symptom of feeling that sight is worsening on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	20	29
Frequency	0.20 (0.41)	0.45 (0.63)
Intensity	1.00 (0.00)	1.00 (0.00)

46. Primary Outcome

Title	Symptom of Headache
Description	Symptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Intensity of symptom of headache was measured only for subjects who had frequency of symptom of headache on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	32	29
Frequency	0.72 (0.63)	0.69 (0.60)
Intensity	1.10 (0.30)	1.06 (0.24)

47. Primary Outcome

Title	Symptom of Headache
Description	Symptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

One subject score was not measured for Habitual spectacles group. Intensity of symptom of headache was measured only for subjects who had frequency of symptom of headache on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	28	28
Frequency	0.33 (0.48)	0.54 (0.58)
Intensity	1.22 (0.44)	1.14 (0.36)

48. Primary Outcome

Title	Symptom of Headache
Description	Symptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Time Frame	Two Months

Outcome Measure Data

Analysis Population Description

Intensity of symptom of headache was measured only for subjects who had frequency of symptom of headache on a scale of 1 - occasionally and 2- often/always

Arm/Group Title	Comfilcon A Asphere	Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens	Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
Measure Participants	20	29
Frequency	0.30 (0.47)	0.55 (0.51)
ntensity	1.00 (0.00)	1.13 (0.34)

Adverse Events

Time Frame	From baseline visit up to two months, a total of two months.
Arm/Group Title	Comfilcon A Asphere		Habitual Spectacles
Arm/Group Description	Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week. comfilcon A asphere: Contact Lens		Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week. Spectacles: Habitual spectacles
All Cause Mortality
	Comfilcon A Asphere		Habitual Spectacles
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/29 (0%)
Serious Adverse Events
	Comfilcon A Asphere		Habitual Spectacles
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Comfilcon A Asphere		Habitual Spectacles
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/32 (3.1%)		0/29 (0%)
Eye disorders
Conjunctivitis	1/32 (3.1%)	1	0/29 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.