Daily Disposable Comparison Study

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02094677
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 1
• Patients Per Site Per Month: 68.7

Study Details

Study Description

Brief Summary

The objective of the study is to compare the overall subjective preference between two Daily Disposable hydrogel lenses when refitted into a third hydrogel lens.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: filcon II 3; Device: etafilcon A; Device: nelfilcon A	N/A

Detailed Description

This was a two-day, randomized, non-dispensing, double-masked, contralateral study with two parallel groups. Participants were recruited into one of two groups - participants who habitually wore etafilcon A lens and participants who habitually wore nelfilcon A lens.

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: Daily Disposable Comparison Study
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: filcon II 3 and etafilcon A Participants were randomized to a test and control lens for each group in a contralateral design.	Device: filcon II 3; Participants were randomized to wear filcon II 3 test lens.; Other Names: Hydrogel Daily Disposable Contact Lens ; Device: etafilcon A; Participants were randomized to wear etafilcon A control lens.; Other Names: Hydrogel Daily Disposable Contact Lens 1 Day Acuvue Moist
Active Comparator: filcon II 3 and nelfilcon A Participants were randomized to a test and control lens for each group in a contralateral design.	Device: filcon II 3; Participants were randomized to wear filcon II 3 test lens.; Other Names: Hydrogel Daily Disposable Contact Lens ; Device: nelfilcon A; Participants were randomized to wear nelfilcon A control lens.; Other Names: Hydrogel Daily Disposable Contact Lens Dailies Aqua Comfort Plus

Outcome Measures

Primary Outcome Measures

1. Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A [Baseline visit]

   Participant's subjective response for lens preference of filcon II 3 and etafilcon A or filcon II 3 and nelfilcon A at baseline visit, following insertion, after settling 10-15mins (surveyed at baseline visit) rated by questionnaire. (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).

2. Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A [3 hours]

   Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 3 hours lens wear rated by questionnaire. (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).

3. Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A [6 hours]

   Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 6 hours lens wear rated by questionnaire (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).

Secondary Outcome Measures

1. Lens Comfort - Filcon II 3 and Etafilcon A [Baseline, 3 hours, 6 hours]

   Participant's subjective response for lens comfort of filcon II 3 and etafilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).

2. Lens Comfort - Filcon II 3 and Nelficon A [Baseline, 3 hours, 6 hours]

   Participant's subjective response for lens comfort of filcon II 3 and nelfilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).

3. Lens Dryness - Filcon II 3 and Etafilcon A [3 hours and 6 hours]

   Participant's subjective response for lens dryness of filcon II 3 and etafilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry 100=no dryness experienced).

4. Lens Dryness - Filcon II 3 and Nelfilcon A [3 hours and 6 hours]

   Participant's subjective response for lens dryness of filcon II 3 and nelfilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced).

5. Lens Handling - Filcon II 3 and Etafilcon A [Baseline visit]

   Participant's subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle causes pain, 100=very easy to handle).

6. Lens Handling - Filcon II 3 and Nelfilcon A [Baseline visit]

   Participant's subjective response for lens handling of filcon II 3 and nelfilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).

7. Lens Handling (Removal) - Filcon II 3 and Etafilcon A [6 hours]

   Participant's subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).

8. Lens Handling (Removal) - Filcon II 3 and Nelfilcon A [6 hours]

   Participant's subjective response for lens handling of filcon II 3 and nelfilcon A following removal (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).

9. Lens Wettability - Filcon II 3 and Etafilcon A [Baseline and 6 hours]

   The ophthalmologist's objective assessment for lens wettability of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).

10. Lens Wettability - Filcon II 3 and Nelfilcon A [Baseline and 6 hours]

    The ophthalmologist's objective assessment for lens wettability of filcon II 3 and nelficon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).

11. Lens Fit, Centration - Filcon II 3 and Etafilcon A [Baseline]

    The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at baseline visit) by biomicroscopy (Optimum or Decentered N T S I). N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior

12. Lens Fit, Centration - Filcon II 3 and Etafilcon A [6 hours]

    The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior

13. Lens Fit, Centration - Filcon II 3 and Nelfilcon A [Baseline]

    The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at baseline) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior

14. Lens Fit, Centration - Filcon II 3 and Nelfilcon A [After 6 hours]

    The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior

15. Lens Fit, Post-Blink Movement - Filcon II 3 and Etafilcon A [Baseline and 6 hours]

    The ophthalmologist's objective assessment for lens fit for Post-Blink Movement of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).

16. Lens Fit, Post-Blink Movement - Filcon II 3 and Nelfilcon A [Baseline and 6 hours]

    The ophthalmologist's objective assessment for lens fit for Post-Blink Movement of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).

17. Lens Fit, Tightness - Filcon II 3 and Etafilcon A [Baseline and 6 hours]

    The ophthalmologist's objective assessment for lens fit for tightness of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).

18. Lens Fit, Tightness - Filcon II 3 and Nelfilcon A [Baseline and 6 hours]

    The ophthalmologist's objective assessment for lens fit for tightness of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).

19. Lens Surface Deposition - Filcon II 3 and Etafilcon A [6 hour]

    The ophthalmologist's objective assessment for lens surface deposition of filcon II 3 and etafilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).

20. Lens Surface Deposition - Filcon II 3 and Nelfilcon A [6 hour]

    The ophthalmologist's objective assessment for lens surface deposition of filcon II 3 and nelfilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).

21. High Contrast Visual Acuity - Filcon II 3 and Etafilcon A [Baseline and 6 hours]

    The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and etafilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value).

22. High Contrast Visual Acuity - Filcon II 3 and Nelfilcon A [Baseline and 6 hours]

    The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and nelfilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value)

23. Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A [6 hours]

    The ophthalmologist's objective assessment of corneal staining (extent) assessed at screening (before lens insertion) by biomicroscopy (Grade as a % of each zone). N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central

24. Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A [6 hours]

    The ophthalmologist's objective assessment of corneal staining (extent) assessed at 6 hours by biomicroscopy (Grade as a % of each zone). N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central

25. Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Etafilcon A [Baseline and 6 hours]

    The ophthalmologist's objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).

26. Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Nelfilcon A [Baseline and 6 hours]

    The ophthalmologist's objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion of filcon II 3 and nelfilcon A) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Is at least 17 years of age and has full legal capacity to volunteer;

2. Has read and signed an information consent letter;

3. Is willing and able to follow instructions and maintain the appointment schedule;

4. Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual correction and the assigned study lenses;

5. Habitually wears either 1 Day Acuvue Moist or Dailies Aqua Comfort Plus contact lenses.

6. Demonstrates an acceptable fit with the study lenses

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;

2. Has any known active* ocular disease and/or infection;

3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;

4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;

5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;

6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);

7. Is aphakic;

8. Has undergone refractive error surgery;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Contact Lens Research	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02094677
• Other Study ID Numbers: EX-MKTG-50
• First Posted: Mar 24, 2014
• Last Update Posted: Jul 28, 2020
• Last Verified: Jul 1, 2020

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	Seventy four participants were enrolled into the study and 70 participants were randomized and completed the study. 40 were habitual wearers of etafilcon A lens and 30 were habitual wearers of nelfilcon A lens.

Arm/Group Title	Filcon II 3 and Etafilcon A	Filcon II 3 and Nelfilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
Period Title: Overall Study
STARTED	43	31
COMPLETED	40	30
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	Filcon II 3 and Etafilcon A	Filcon II 3 and Nelfilcon A	Total
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.	Total of all reporting groups
Overall Participants	40	30	70
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28 (9)	33.1 (12.4)	30.2 (10.8)
Sex: Female, Male (Count of Participants)
Female	27 67.5%	23 76.7%	50 71.4%
Male	13 32.5%	7 23.3%	20 28.6%
Region of Enrollment (participants) [Number]
Canada	40 100%	30 100%	70 100%

Outcome Measures

1. Primary Outcome

Title	Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Description	Participant's subjective response for lens preference of filcon II 3 and etafilcon A or filcon II 3 and nelfilcon A at baseline visit, following insertion, after settling 10-15mins (surveyed at baseline visit) rated by questionnaire. (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).
Time Frame	Baseline visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Filcon II 3 and Etafilcon A	Filcon II 3 and Nelfilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
Measure Participants	40	30
Strongly prefer filcon II 3	1 2.5%	3 10%
Slightly prefer filcon II 3	14 35%	8 26.7%
No preference	8 20%	10 33.3%
Slightly prefer etafilcon A/nelfilcon A	8 20%	6 20%
Strongly prefer etafilcon A/nelfilcon A	9 22.5%	3 10%

2. Primary Outcome

Title	Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Description	Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 3 hours lens wear rated by questionnaire. (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).
Time Frame	3 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Filcon II 3 and Etafilcon A	Filcon II 3 and Nelfilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
Measure Participants	40	30
Strongly prefer filcon II 3	1 2.5%	3 10%
Slightly prefer filcon II 3	10 25%	12 40%
No preference	7 17.5%	5 16.7%
Slightly prefer etafilcon A/nelfilcon A	13 32.5%	8 26.7%
Strongly prefer etafilcon A/nelfilcon A	9 22.5%	2 6.7%

3. Primary Outcome

Title	Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Description	Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 6 hours lens wear rated by questionnaire (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).
Time Frame	6 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Filcon II 3 and Etafilcon A	Filcon II 3 and Nelfilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
Measure Participants	40	30
Strongly prefer filcon II 3	2 5%	5 16.7%
Slightly prefer filcon II 3	9 22.5%	8 26.7%
No preference	7 17.5%	9 30%
Slightly prefer etafilcon A/nelfilcon A	11 27.5%	5 16.7%
Strongly prefer etafilcon A/nelfilcon A	11 27.5%	3 10%

4. Secondary Outcome

Title	Lens Comfort - Filcon II 3 and Etafilcon A
Description	Participant's subjective response for lens comfort of filcon II 3 and etafilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
Time Frame	Baseline, 3 hours, 6 hours

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.

Arm/Group Title	Filcon II 3	Control - Etafilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.
Measure Participants	40	40
Habitual lens (before study lens dispensed)	78 (18)	77 (20)
Baseline (study lens)	84 (18)	90 (10)
3 hours	79 (22)	87 (14)
6 hours	75 (24)	83 (18)

5. Secondary Outcome

Title	Lens Comfort - Filcon II 3 and Nelficon A
Description	Participant's subjective response for lens comfort of filcon II 3 and nelfilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
Time Frame	Baseline, 3 hours, 6 hours

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.

Arm/Group Title	Filcon II 3	Control - Nelfilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
Measure Participants	30	30
Habitual lens (before study lens dispensed)	67 (17)	67 (18)
Baseline (study lens)	85 (14)	88 (14)
3 hours	79 (16)	75 (17)
6 hours	76 (24)	72 (23)

6. Secondary Outcome

Title	Lens Dryness - Filcon II 3 and Etafilcon A
Description	Participant's subjective response for lens dryness of filcon II 3 and etafilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry 100=no dryness experienced).
Time Frame	3 hours and 6 hours

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.

Arm/Group Title	Filcon II 3	Control - Etafilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.
Measure Participants	40	40
Habitual lens (before study lens dispensed)	72 (19)	70 (20)
3 hours	78 (24)	85 (15)
6 hours	75 (23)	82 (18)

7. Secondary Outcome

Title	Lens Dryness - Filcon II 3 and Nelfilcon A
Description	Participant's subjective response for lens dryness of filcon II 3 and nelfilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced).
Time Frame	3 hours and 6 hours

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.

Arm/Group Title	Filcon II 3	Control - Nelfilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
Measure Participants	30	30
Habitual lens (before study lens dispensedl	66 (20)	66 (19)
3 hours	79 (16)	76 (19)
6 hours	77 (21)	74 (23)

8. Secondary Outcome

Title	Lens Handling - Filcon II 3 and Etafilcon A
Description	Participant's subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle causes pain, 100=very easy to handle).
Time Frame	Baseline visit

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.

Arm/Group Title	Filcon II 3	Control - Etafilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.
Measure Participants	40	40
Habitual lens (before study lens dispensed)	92 (10)	92 (10)
Baseline (study lens)	93 (9)	91 (10)

9. Secondary Outcome

Title	Lens Handling - Filcon II 3 and Nelfilcon A
Description	Participant's subjective response for lens handling of filcon II 3 and nelfilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).
Time Frame	Baseline visit

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.

Arm/Group Title	Filcon II 3	Control - Nelfilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
Measure Participants	30	30
Habitual lens (before study lens dispensed)	90 (14)	90 (14)
Baseline (study lens)	92 (14)	92 (14)

10. Secondary Outcome

Title	Lens Handling (Removal) - Filcon II 3 and Etafilcon A
Description	Participant's subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).
Time Frame	6 hours

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.

Arm/Group Title	Filcon II 3	Control - Etafilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.
Measure Participants	40	40
Habitual lens (before study lens dispensed)	95 (10)	95 (10)
6 hours	95 (12)	97 (6)

11. Secondary Outcome

Title	Lens Handling (Removal) - Filcon II 3 and Nelfilcon A
Description	Participant's subjective response for lens handling of filcon II 3 and nelfilcon A following removal (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).
Time Frame	6 hours

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.

Arm/Group Title	Filcon II 3	Control - Nelfilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
Measure Participants	30	30
Habitual lens (before study lens dispensed)	90 (14)	89 (15)
6 hours	94 (16)	94 (10)

12. Secondary Outcome

Title	Lens Wettability - Filcon II 3 and Etafilcon A
Description	The ophthalmologist's objective assessment for lens wettability of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).
Time Frame	Baseline and 6 hours

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.

Arm/Group Title	Filcon II 3	Control - Etafilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.
Measure Participants	40	40
Baseline	0.40 (0.73)	0.33 (0.57)
6 hours	0.95 (0.89)	1.03 (1.12)

13. Secondary Outcome

Title	Lens Wettability - Filcon II 3 and Nelfilcon A
Description	The ophthalmologist's objective assessment for lens wettability of filcon II 3 and nelficon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).
Time Frame	Baseline and 6 hours

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.

Arm/Group Title	Filcon II 3	Control - Nelfilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
Measure Participants	30	30
Baseline	0.38 (0.46)	0.25 (0.35)
6 hours	0.93 (0.82)	0.73 (0.79)

14. Secondary Outcome

Title	Lens Fit, Centration - Filcon II 3 and Etafilcon A
Description	The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at baseline visit) by biomicroscopy (Optimum or Decentered N T S I). N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.

Arm/Group Title	Filcon II 3	Control - Etafilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.
Measure Participants	40	40
Optimum	13 32.5%	13 43.3%
N	0 0%	1 3.3%
T	8 20%	9 30%
S	2 5%	4 13.3%
I	5 12.5%	3 10%
N/S	0 0%	0 0%
N/I	0 0%	1 3.3%
T/S	5 12.5%	1 3.3%
T/I	7 17.5%	8 26.7%

15. Secondary Outcome

Title	Lens Fit, Centration - Filcon II 3 and Etafilcon A
Description	The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior
Time Frame	6 hours

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.

Arm/Group Title	Filcon II 3	Control - Etafilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.
Measure Participants	40	40
Optimum	16 40%	14 46.7%
N	0 0%	1 3.3%
T	9 22.5%	9 30%
S	2 5%	5 16.7%
I	2 5%	1 3.3%
N/S	1 2.5%	0 0%
N/I	0 0%	0 0%
T/S	6 15%	4 13.3%
T/I	4 10%	6 20%

16. Secondary Outcome

Title	Lens Fit, Centration - Filcon II 3 and Nelfilcon A
Description	The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at baseline) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.

Arm/Group Title	Filcon II 3	Control - Nelfilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
Measure Participants	30	30
Optimum	11 27.5%	14 46.7%
N	1 2.5%	0 0%
T	3 7.5%	2 6.7%
S	2 5%	2 6.7%
I	3 7.5%	2 6.7%
N/S	1 2.5%	1 3.3%
N/I	0 0%	2 6.7%
T/S	7 17.5%	4 13.3%
T/I	2 5%	3 10%

17. Secondary Outcome

Title	Lens Fit, Centration - Filcon II 3 and Nelfilcon A
Description	The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior
Time Frame	After 6 hours

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.

Arm/Group Title	Filcon II 3	Control - Nelfilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
Measure Participants	30	30
Optimum	11 27.5%	12 40%
Nasal	1 2.5%	1 3.3%
T	4 10%	4 13.3%
S	4 10%	2 6.7%
I	0 0%	1 3.3%
N/S	1 2.5%	1 3.3%
N/I	0 0%	1 3.3%
T/S	7 17.5%	4 13.3%
T/I	2 5%	4 13.3%

18. Secondary Outcome

Title	Lens Fit, Post-Blink Movement - Filcon II 3 and Etafilcon A
Description	The ophthalmologist's objective assessment for lens fit for Post-Blink Movement of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).
Time Frame	Baseline and 6 hours

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.

Arm/Group Title	Filcon II 3	Control - Etafilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens
Measure Participants	40	40
Baseline	0.28 (0.15)	0.24 (0.15)
6 hours	0.30 (0.16)	0.26 (0.14)

19. Secondary Outcome

Title	Lens Fit, Post-Blink Movement - Filcon II 3 and Nelfilcon A
Description	The ophthalmologist's objective assessment for lens fit for Post-Blink Movement of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).
Time Frame	Baseline and 6 hours

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.

Arm/Group Title	Filcon II 3	Control - Nelfilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
Measure Participants	30	30
Baseline	0.26 (0.11)	0.24 (0.10)
6 hours	0.23 (0.08)	0.24 (0.11)

20. Secondary Outcome

Title	Lens Fit, Tightness - Filcon II 3 and Etafilcon A
Description	The ophthalmologist's objective assessment for lens fit for tightness of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).
Time Frame	Baseline and 6 hours

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.

Arm/Group Title	Filcon II 3	Control - Etafilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.
Measure Participants	40	40
Baseline	48 (6)	50 (6)
6 hours	49 (5)	51 (6)

21. Secondary Outcome

Title	Lens Fit, Tightness - Filcon II 3 and Nelfilcon A
Description	The ophthalmologist's objective assessment for lens fit for tightness of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).
Time Frame	Baseline and 6 hours

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.

Arm/Group Title	Filcon II 3	Control - Nelfilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
Measure Participants	30	30
Baseline	50 (7)	52 (7)
6 hours	52 (6)	53 (8)

22. Secondary Outcome

Title	Lens Surface Deposition - Filcon II 3 and Etafilcon A
Description	The ophthalmologist's objective assessment for lens surface deposition of filcon II 3 and etafilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).
Time Frame	6 hour

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.

Arm/Group Title	Filcon II 3	Control - Etafilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.
Measure Participants	40	40
Mean (Standard Deviation) [units on a scale]	0.26 (0.27)	0.37 (0.47)

23. Secondary Outcome

Title	Lens Surface Deposition - Filcon II 3 and Nelfilcon A
Description	The ophthalmologist's objective assessment for lens surface deposition of filcon II 3 and nelfilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).
Time Frame	6 hour

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.

Arm/Group Title	Filcon II 3	Control - Nelfilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
Measure Participants	30	30
Mean (Standard Deviation) [units on a scale]	0.27 (0.33)	0.30 (0.32)

24. Secondary Outcome

Title	High Contrast Visual Acuity - Filcon II 3 and Etafilcon A
Description	The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and etafilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value).
Time Frame	Baseline and 6 hours

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.

Arm/Group Title	Filcon II 3	Control - Etafilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.
Measure Participants	40	40
Baseline	-0.08 (0.07)	-0.06 (0.07)
6 hours	-0.09 (0.07)	-0.07 (0.08)

25. Secondary Outcome

Title	High Contrast Visual Acuity - Filcon II 3 and Nelfilcon A
Description	The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and nelfilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value)
Time Frame	Baseline and 6 hours

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.

Arm/Group Title	Filcon II 3	Control - Nelilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
Measure Participants	30	30
Baseline	-0.07 (0.07)	-0.07 (0.07)
6 hours	-0.08 (0.07)	-0.10 (0.08)

26. Secondary Outcome

Title	Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A
Description	The ophthalmologist's objective assessment of corneal staining (extent) assessed at screening (before lens insertion) by biomicroscopy (Grade as a % of each zone). N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central
Time Frame	6 hours

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.

Arm/Group Title	Filcon II 3	Control - Etafilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.
Measure Participants	40	40
N	4 (8)	0 (1)
T	1 (6)	1 (2)
S	3 (8)	2 (5)
I	9 (12)	4 (6)
C	0 (2)	0 (1)

27. Secondary Outcome

Title	Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A
Description	The ophthalmologist's objective assessment of corneal staining (extent) assessed at 6 hours by biomicroscopy (Grade as a % of each zone). N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central
Time Frame	6 hours

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.

Arm/Group Title	Filcon II 3	Control - Nelfilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
Measure Participants	30	30
N	2 (5)	2 (5)
T	1 (5)	0 (1)
S	2 (5)	2 (7)
I	6 (8)	4 (5)
C	2 (9)	0 (1)

28. Secondary Outcome

Title	Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Etafilcon A
Description	The ophthalmologist's objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).
Time Frame	Baseline and 6 hours

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.

Arm/Group Title	Filcon II 3	Control - Etafilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. etafilcon A: Participants were randomized to wear etafilcon A control lens.
Measure Participants	40	40
Bulbar	1.89 (0.38)	1.81 (0.39)
Limbal	1.75 (0.47)	1.68 (0.51)

29. Secondary Outcome

Title	Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Nelfilcon A
Description	The ophthalmologist's objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion of filcon II 3 and nelfilcon A) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).
Time Frame	Baseline and 6 hours

Outcome Measure Data

Analysis Population Description

These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.

Arm/Group Title	Filcon II 3	Control - Nelfilcon A
Arm/Group Description	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.	Participants were randomized to a test and control lens in a contralateral design. filcon II 3: Participants were randomized to wear filcon II 3 test lens. nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
Measure Participants	30	30
Bulbar	1.67 (0.46)	1.57 (0.29)
Limbal	1.35 (0.49)	1.27 (0.37)

Adverse Events

Time Frame	From dispense up to 2 days for each study lenses
Arm/Group Title	Filcon II 3 and Etafilcon A		Filcon II 3 and Nelfilcon A
Arm/Group Description	Participants wear one of their habitual brand lenses (etafilcon A) in one eye, (comparator) and one comparator lens (filcon II 3) in the other eye. filcon II 3: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other. etafilcon A: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other.		Participants wear one of their habitual brand lenses (nelfilcon A) in one eye, (comparator) and one comparator lens (filcon II 3) in the other eye. filcon II 3: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other. nelfilcon A: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other.
All Cause Mortality
	Filcon II 3 and Etafilcon A		Filcon II 3 and Nelfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Filcon II 3 and Etafilcon A		Filcon II 3 and Nelfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Filcon II 3 and Etafilcon A		Filcon II 3 and Nelfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Principal Investigators are NOT employed by the organization sponsoring the study. There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.