A Clinical Comparison of 2 Multifocal Toric XR (Extended Range) Contact Lenses

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03006458
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 4.1
• Patients Per Site Per Month: 5.8

Study Details

Study Description

Brief Summary

This study aims to compare the clinical performance and subjective acceptance of the comfilcon A and the omafilcon B soft contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Astigmatism	Device: comfilcon A; Device: omafilcon B	N/A

Detailed Description

This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross comparison. Thirty subjects will use each lens type for two weeks in random sequence. Follow-up visits for each lens will be performed after two weeks of wear. Lenses will be worn on a daily wear basis.

The final optical design of comfilcon A contact lens was optimized to improve the quality and two further studies (CV-18-10 and CV-18-11) were conducted after completion of this study to evaluate the modified optical design.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Clinical Comparison of the Comfilcon A (Extended Range) XR Toric Multifocal and Omafilcon B Toric XR Multifocal Contact Lenses
• Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: Apr 6, 2017
• Actual Study Completion Date: Apr 6, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: comfilcon A Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. The final optical design of comfilcon A contact lens was optimized to improve the quality and two further studies (CV-18-10 and CV-18-11) were conducted after completion of this study to evaluate the modified optical design.	Device: comfilcon A; toric contact lens
Active Comparator: omafilcon B Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.	Device: omafilcon B; toric contact lens

Outcome Measures

Primary Outcome Measures

1. Stability [Baseline]

   Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.

2. Stability [2 weeks]

   Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.

3. Overall Toric Lens Fit Acceptance [Baseline]

   Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.

4. Overall Toric Lens Fit Acceptance [2 weeks]

   Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.

5. Comfort [Baseline]

   Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever

6. Comfort [2 weeks]

   Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever

7. Overall Satisfaction [2 weeks]

   Subjective ratings for overall satisfaction for comfilcon A and omafilcon B lenses assessed. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied

8. Dryness [2 weeks]

   Subjective ratings for dryness assessed. Scale 0-100, 0=cannot be worn, extremely dry; 100=no dryness experienced at any time

9. Visual Fluctuation/ Stability [2 weeks]

   Subjective ratings for visual fluctuation/stability assessed. Scale 0-100, 0=totally unstable/ fluctuation/changing; 100=perfectly stable/not fluctuation/changing

10. Handling [2 weeks]

    Subjective ratings for handling difficulty assessed at 2 weeks. Scale 0-100, 0=very difficult, 100=very easy

11. Quality of Near Vision [2 weeks]

    Subjective ratings for quality of near vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.

12. Quality of Intermediate Vision [2 weeks]

    Subjective ratings for quality of intermediate vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.

13. Quality of Distance Vision [2 weeks]

    Subjective ratings for quality of distance vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.

14. Quality of Vision While Driving During the Day [2 weeks]

    Subjective rating for quality of vision while driving during the day. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.

15. Quality of Vision While Driving During the Night [2 weeks]

    Subjective ratings for quality of vision while driving at night. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.

16. Ghosting at Near [2 weeks]

    Subjective ratings for ghosting at near assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.

17. Ghosting at Distance [2 weeks]

    Subjective ratings for ghosting at distance assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects will only be eligible for the study if:

1. They are aged 40 - 70 years, inclusive.

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

3. They are willing and able to follow the protocol.

4. They have successfully completed the non-dispensing study (C16-597) as the lenses to be worn on this study (C16-599) are predetermined from their participation on study C16-597.

5. They have a contact lens spherical prescription between +10.00 to -10.00D (Diopters) (inclusive).

6. They have astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye.

7. They have an Add component to their spectacle refraction (between +0.75 and

+2.50DS).

1. They can be satisfactorily fitted with the study lenses.

2. They can attain at least 0.30 logMAR binocular distance high contrast visual acuity with the study lenses within the available power range.

3. They have successfully worn soft contact lenses in the last two years.

4. They are willing to comply with the wear schedule (at least five days per week and for at least six hours per day).

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

6. They own a wearable pair of spectacles.

Exclusion Criteria:

• Subjects will not be eligible to take part in the study if:

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

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

3. They are using any topical medication such as eye drops or ointment.

4. They have had cataract surgery.

5. They have had corneal refractive surgery.

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

7. They are pregnant or breast-feeding.

8. They have any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. ≥ Grade 3 finding of oedema, corneal neovascularisation, corneal staining, tarsal abnormalities, conjunctival injection, blepharitis/meibomian gland dysfunction) on the Efron classification scale or any other ocular abnormality that in the opinion of the investigator would contraindicate contact lens wear.

9. They have any infectious disease (e.g. hepatitis) 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).

10. They have a history of anaphylaxis or severe allergic reaction.

11. 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	Manchester		United Kingdom	M13 9PL

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 2, 2016

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT03006458
• Other Study ID Numbers: CV-16-28 (C16-599)
• First Posted: Dec 30, 2016
• Last Update Posted: Jun 1, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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: Astigmatism

Study Results

Participant Flow

Arm/Group Title	Comfilcon A Then Omafilcon B	Omafilcon B Then Comfilcon A
Arm/Group Description	Participants were randomized to wear comfilcon A for two weeks during the cross over study. comfilcon A: toric contact lens	Participants were randomized to wear omafilcon B for two weeks during the cross over study. omafilcon B: toric contact lens
Period Title: First Intervention
STARTED	14	10
COMPLETED	14	7
NOT COMPLETED	0	3
Period Title: First Intervention
STARTED	14	10
COMPLETED	14	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Total Participants
Overall Participants	24
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	24 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.2 (6.2)
Sex: Female, Male (Count of Participants)
Female	11 45.8%
Male	13 54.2%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United Kingdom	24 100%

Outcome Measures

1. Primary Outcome

Title	Stability
Description	Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A	Omafilcon B
Arm/Group Description	Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Measure Participants	24	21
Mean (Standard Deviation) [units on a scale]	3.2 (1.5)	2.9 (0.9)

2. Primary Outcome

Title	Stability
Description	Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A	Omafilcon B
Arm/Group Description	Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Measure Participants	24	21
Mean (Standard Deviation) [units on a scale]	3.2 (0.7)	2.5 (1.0)

3. Primary Outcome

Title	Overall Toric Lens Fit Acceptance
Description	Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A	Omafilcon B
Arm/Group Description	Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Measure Participants	24	21
Mean (Standard Deviation) [units on a scale]	3.3 (0.5)	3.2 (0.6)

4. Primary Outcome

Title	Overall Toric Lens Fit Acceptance
Description	Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A	Omafilcon B
Arm/Group Description	Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Measure Participants	24	21
Mean (Standard Deviation) [units on a scale]	3.5 (0.6)	2.8 (0.7)

5. Primary Outcome

Title	Comfort
Description	Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A	Omafilcon B
Arm/Group Description	Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Measure Participants	24	21
Mean (Standard Deviation) [units on a scale]	81.6 (20.3)	79.7 (21.6)

6. Primary Outcome

Title	Comfort
Description	Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A	Omafilcon B
Arm/Group Description	Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Measure Participants	24	21
Mean (Standard Deviation) [units on a scale]	79.8 (21.8)	70.6 (27.2)

7. Primary Outcome

Title	Overall Satisfaction
Description	Subjective ratings for overall satisfaction for comfilcon A and omafilcon B lenses assessed. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A	Omafilcon B
Arm/Group Description	Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Measure Participants	24	21
Mean (Standard Deviation) [units on a scale]	63.0 (31.4)	63.3 (34.4)

8. Primary Outcome

Title	Dryness
Description	Subjective ratings for dryness assessed. Scale 0-100, 0=cannot be worn, extremely dry; 100=no dryness experienced at any time
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A	Omafilcon B
Arm/Group Description	Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Measure Participants	24	21
Mean (Standard Deviation) [units on a scale]	80.4 (24.7)	77.2 (24.1)

9. Primary Outcome

Title	Visual Fluctuation/ Stability
Description	Subjective ratings for visual fluctuation/stability assessed. Scale 0-100, 0=totally unstable/ fluctuation/changing; 100=perfectly stable/not fluctuation/changing
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A	Omafilcon B
Arm/Group Description	Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Measure Participants	24	21
Mean (Standard Deviation) [units on a scale]	81.0 (16.1)	73.8 (25.5)

10. Primary Outcome

Title	Handling
Description	Subjective ratings for handling difficulty assessed at 2 weeks. Scale 0-100, 0=very difficult, 100=very easy
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A	Omafilcon B
Arm/Group Description	Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Measure Participants	24	21
Mean (Standard Deviation) [units on a scale]	84.5 (15.0)	85.8 (17.1)

11. Primary Outcome

Title	Quality of Near Vision
Description	Subjective ratings for quality of near vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A	Omafilcon B
Arm/Group Description	Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Measure Participants	24	21
Mean (Standard Deviation) [units on a scale]	38.5 (30.5)	56.4 (28.9)

12. Primary Outcome

Title	Quality of Intermediate Vision
Description	Subjective ratings for quality of intermediate vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A	Omafilcon B
Arm/Group Description	Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Measure Participants	24	21
Mean (Standard Deviation) [units on a scale]	50.2 (29.5)	65.3 (25.6)

13. Primary Outcome

Title	Quality of Distance Vision
Description	Subjective ratings for quality of distance vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A	Omafilcon B
Arm/Group Description	Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Measure Participants	24	21
Mean (Standard Deviation) [units on a scale]	86.2 (13.7)	67.3 (25.5)

14. Primary Outcome

Title	Quality of Vision While Driving During the Day
Description	Subjective rating for quality of vision while driving during the day. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A	Omafilcon B
Arm/Group Description	Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Measure Participants	20	17
Mean (Standard Deviation) [units on a scale]	87.3 (14.6)	76.2 (25.4)

15. Primary Outcome

Title	Quality of Vision While Driving During the Night
Description	Subjective ratings for quality of vision while driving at night. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A	Omafilcon B
Arm/Group Description	Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Measure Participants	20	15
Mean (Standard Deviation) [units on a scale]	78.0 (18.6)	67.0 (23.4)

16. Primary Outcome

Title	Ghosting at Near
Description	Subjective ratings for ghosting at near assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A	Omafilcon B
Arm/Group Description	Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Measure Participants	23	21
Mean (Standard Deviation) [units on a scale]	66.5 (35.0)	78.1 (27.0)

17. Primary Outcome

Title	Ghosting at Distance
Description	Subjective ratings for ghosting at distance assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A	Omafilcon B
Arm/Group Description	Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens	Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
Measure Participants	24	21
Mean (Standard Deviation) [units on a scale]	83.3 (24.8)	86.9 (24.4)

Adverse Events

Time Frame	From baseline to follow up visit for an average of 2 weeks.
Arm/Group Title	Comfilcon A		Omafilcon B
Arm/Group Description	Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. comfilcon A: toric contact lens		Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study. omafilcon B: toric contact lens
All Cause Mortality
	Comfilcon A		Omafilcon B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/21 (0%)
Serious Adverse Events
	Comfilcon A		Omafilcon B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/21 (0%)
Other (Not Including Serious) Adverse Events
	Comfilcon A		Omafilcon B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/21 (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.