A Dispensing Clinical Trial of Test Contact Lens Against Marketed Contact Lens

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03499067
• Collaborator: (none)
• Enrollment: 58
• Locations: 2
• Arms: 2
• Actual Duration (Months): 3.7
• Patients Per Site: 29
• Patients Per Site Per Month: 7.9

Study Details

Study Description

Brief Summary

Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed lens (control), when worn on a daily basis for 1 month.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Test lens; Device: Control lens

Detailed Description

Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed silicone- hydrogel contact lens (control), when worn on a daily basis for 1 month.

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Each subject will be randomized to wear the test or control contact lens for 1 month and then crossed-over to wear the other contact lens for 1 month.Each subject will be randomized to wear the test or control contact lens for 1 month and then crossed-over to wear the other contact lens for 1 month.
• Masking: Double (Participant, Investigator)
• Masking Description: This will be a double-masked study in which both participant and investigator will be masked.
• Primary Purpose: Treatment
• Official Title: A Dispensing Clinical Trial of Invigor I Lens Against Clariti Lens
• Actual Study Start Date: Apr 11, 2018
• Actual Primary Completion Date: Aug 1, 2018
• Actual Study Completion Date: Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test lens Subjects wearing the test contact lens either as first or second pair during the cross-over study.	Device: Test lens; Contact lens; Other Names: Invigor I lens ; Device: Control lens; Contact lens; Other Names: Clariti lens
Active Comparator: Control lens Subjects wearing the control contact lens either as first or second pair during the cross-over study.	Device: Test lens; Contact lens; Other Names: Invigor I lens ; Device: Control lens; Contact lens; Other Names: Clariti lens

Outcome Measures

Primary Outcome Measures

1. Lens Surface Wettability [Baseline]

   Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time << blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)

2. Lens Surface Wettability [2-weeks]

   Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time << blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)

3. Lens Surface Wettability [4-weeks]

   Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time << blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)

4. Lens Surface Deposits [Baseline]

   Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits, 1: 5 or less small deposits (<0.1mm), 2: >5 deposits of <0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface)

5. Lens Surface Deposits [2-weeks]

   Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits,1: 5 or less small deposits (<0.1mm), 2: >5 deposits of <0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface).

6. Lens Surface Deposits [4-weeks]

   Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits,1: 5 or less small deposits (<0.1mm), 2: >5 deposits of <0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface)

7. Overall Lens Fit Acceptance [Baseline]

   Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)

8. Overall Lens Fit Acceptance [2-Weeks]

   Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)

9. Overall Lens Fit Acceptance [4-Weeks]

   Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)

10. Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration [Baseline]

    Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (<0.5mm), Extremely decentered (>0.5mm)

11. Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration [2-weeks]

    Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (<0.5mm), Extremely decentered (>0.5mm)

12. Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration [4-weeks]

    Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (<0.5mm), Extremely decentered (>0.5mm)

Secondary Outcome Measures

1. Bulbar Conjunctiva Hyperaemia [Baseline]

   Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)

2. Bulbar Conjunctiva Hyperaemia [2-weeks]

   Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)

3. Bulbar Conjunctiva Hyperaemia [4-weeks]

   Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)

4. Limbal Conjunctiva Hyperaemia [Baseline]

   Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)

5. Limbal Conjunctiva Hyperaemia [2-weeks]

   Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)

6. Limbal Conjunctiva Hyperaemia [4-weeks]

   Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Has had a self-reported oculo-visual examination in the last two years.

• Is at least 18 years of age and has full legal capacity to volunteer.

• Has read and understood the information consent letter.

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

• Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.

• Currently wears soft contact lenses.

• Requires spectacle lens powers between -0.75 to -6.50 diopters sphere (0.25D steps).

• Has no more than 0.75 diopters of refractive astigmatism.

• Has clear corneas and no active ocular disease.

• Has not worn lenses for at least 12 hours before the examination.

• Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit

Exclusion Criteria:

• Has never worn contact lenses before.

• Has any systemic disease affecting ocular health.

• Is using any systemic or topical medications that will affect ocular health.

• Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.

• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.

• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.

• Is aphakic.

• Has undergone corneal refractive surgery.

• Is participating in any other type of eye related clinical or research study.

• Known allergy to a product used in this study (ex. Shellfish allergy)

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Center, University of California, Berkeley	Berkeley	California	United States	94704
2	Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University	Bloomington	Indiana	United States	47405

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 10, 2018

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT03499067
• Other Study ID Numbers: CV-18-07
• First Posted: Apr 17, 2018
• Last Update Posted: Aug 26, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Test Lens Then Control Lens	Control Lens Then Test Lens
Arm/Group Description	Subjects were randomized to wear test lens for one month then control lens for one month during the cross-over study. Test lens: Contact lens Control lens: Contact lens	Subjects were randomized to wear control lens for one month then test lens for one month during the cross-over study. Test lens: Contact lens Control lens: Contact lens
Period Title: First Intervention
STARTED	27	31
COMPLETED	22	24
NOT COMPLETED	5	7
Period Title: First Intervention
STARTED	22	24
COMPLETED	22	24
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Total participants
Overall Participants	58
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	58 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27 (6)
Sex: Female, Male (Count of Participants)
Female	44 75.9%
Male	14 24.1%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	58 100%

Outcome Measures

1. Primary Outcome

Title	Lens Surface Wettability
Description	Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time << blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one month in this cross-over study. Test lens: Contact lens	Subjects were randomized to wear control contact lens for one month in this cross-over study. Control lens: Contact lens
Measure Participants	46	46
Mean (Standard Deviation) [units on a scale]	3.26 (0.48)	3.26 (0.44)

2. Primary Outcome

Title	Lens Surface Wettability
Description	Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time << blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)
Time Frame	2-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one month in this cross-over study. Test lens: Contact lens	Subjects were randomized to wear control contact lens for one month in this cross-over study. Control lens: Contact lens
Measure Participants	46	46
Mean (Standard Deviation) [units on a scale]	3.18 (0.53)	3.25 (0.47)

3. Primary Outcome

Title	Lens Surface Wettability
Description	Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time << blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)
Time Frame	4-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one month in this cross-over study. Test lens: Contact lens	Subjects were randomized to wear control contact lens for one month in this cross-over study. Control lens: Contact lens
Measure Participants	46	46
Mean (Standard Deviation) [units on a scale]	3.11 (0.51)	3.01 (0.62)

4. Primary Outcome

Title	Lens Surface Deposits
Description	Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits, 1: 5 or less small deposits (<0.1mm), 2: >5 deposits of <0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one month in this cross-over study. Test lens: Contact lens	Subjects were randomized to wear control contact lens for one month in this cross-over study. Control lens: Contact lens
Measure Participants	46	46
Mean (Standard Deviation) [units on a scale]	0.02 (0.12)	0.04 (0.23)

5. Primary Outcome

Title	Lens Surface Deposits
Description	Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits,1: 5 or less small deposits (<0.1mm), 2: >5 deposits of <0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface).
Time Frame	2-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one month in this cross-over study. Test lens: Contact lens	Subjects were randomized to wear control contact lens for one month in this cross-over study. Control lens: Contact lens
Measure Participants	46	46
Mean (Standard Deviation) [units on a scale]	0.30 (0.60)	0.26 (0.53)

6. Primary Outcome

Title	Lens Surface Deposits
Description	Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits,1: 5 or less small deposits (<0.1mm), 2: >5 deposits of <0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface)
Time Frame	4-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one month in this cross-over study. Test lens: Contact lens	Subjects were randomized to wear control contact lens for one month in this cross-over study. Control lens: Contact lens
Measure Participants	46	46
Mean (Standard Deviation) [units on a scale]	0.35 (0.54)	0.38 (0.63)

7. Primary Outcome

Title	Overall Lens Fit Acceptance
Description	Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one month in this cross-over study. Test lens: Contact lens	Subjects were randomized to wear control contact lens for one month in this cross-over study. Control lens: Contact lens
Measure Participants	46	46
Mean (Standard Deviation) [units on a scale]	3.30 (0.33)	3.27 (0.35)

8. Primary Outcome

Title	Overall Lens Fit Acceptance
Description	Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)
Time Frame	2-Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one month in this cross-over study. Test lens: Contact lens	Subjects were randomized to wear control contact lens for one month in this cross-over study. Control lens: Contact lens
Measure Participants	46	46
Mean (Standard Deviation) [units on a scale]	3.28 (0.41)	3.31 (0.35)

9. Primary Outcome

Title	Overall Lens Fit Acceptance
Description	Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)
Time Frame	4-Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one month in this cross-over study. Test lens: Contact lens	Subjects were randomized to wear control contact lens for one month in this cross-over study. Control lens: Contact lens
Measure Participants	46	46
Mean (Standard Deviation) [units on a scale]	3.31 (0.36)	3.13 (0.53)

10. Primary Outcome

Title	Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Description	Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (<0.5mm), Extremely decentered (>0.5mm)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one month in this cross-over study. Test lens: Contact lens	Subjects were randomized to wear control contact lens for one month in this cross-over study. Control lens: Contact lens
Measure Participants	46	46
Optimal	49 84.5%	38 NaN
Slightly Decentered	45 77.6%	55 NaN
Extremely Decentered	6 10.3%	7 NaN

11. Primary Outcome

Title	Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Description	Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (<0.5mm), Extremely decentered (>0.5mm)
Time Frame	2-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one month in this cross-over study. Test lens: Contact lens	Subjects were randomized to wear control contact lens for one month in this cross-over study. Control lens: Contact lens
Measure Participants	46	46
Optimal	57 98.3%	40 NaN
Slightly Decentered	43 74.1%	52 NaN
Extremely Decentered	0 0%	8 NaN

12. Primary Outcome

Title	Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Description	Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (<0.5mm), Extremely decentered (>0.5mm)
Time Frame	4-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one month in this cross-over study. Test lens: Contact lens	Subjects were randomized to wear control contact lens for one month in this cross-over study. Control lens: Contact lens
Measure Participants	46	46
Optimal	59 101.7%	33 NaN
Slightly Decentered	40 69%	59 NaN
Extremely Decentered	1 1.7%	8 NaN

13. Secondary Outcome

Title	Bulbar Conjunctiva Hyperaemia
Description	Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one month in this cross-over study. Test lens: Contact lens	Subjects were randomized to wear control contact lens for one month in this cross-over study. Control lens: Contact lens
Measure Participants	46	46
Mean (Standard Deviation) [units on a scale]	1.11 (0.49)	1.11 (0.49)

14. Secondary Outcome

Title	Bulbar Conjunctiva Hyperaemia
Description	Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time Frame	2-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one month in this cross-over study. Test lens: Contact lens	Subjects were randomized to wear control contact lens for one month in this cross-over study. Control lens: Contact lens
Measure Participants	46	46
Mean (Standard Deviation) [units on a scale]	1.20 (0.45)	1.23 (0.43)

15. Secondary Outcome

Title	Bulbar Conjunctiva Hyperaemia
Description	Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time Frame	4-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one month in this cross-over study. Test lens: Contact lens	Subjects were randomized to wear control contact lens for one month in this cross-over study. Control lens: Contact lens
Measure Participants	46	46
Mean (Standard Deviation) [units on a scale]	1.15 (0.47)	1.27 (0.43)

16. Secondary Outcome

Title	Limbal Conjunctiva Hyperaemia
Description	Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one month in this cross-over study. Test lens: Contact lens	Subjects were randomized to wear control contact lens for one month in this cross-over study. Control lens: Contact lens
Measure Participants	46	46
Mean (Standard Deviation) [units on a scale]	0.57 (0.35)	0.57 (0.35)

17. Secondary Outcome

Title	Limbal Conjunctiva Hyperaemia
Description	Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time Frame	2-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one month in this cross-over study. Test lens: Contact lens	Subjects were randomized to wear control contact lens for one month in this cross-over study. Control lens: Contact lens
Measure Participants	46	46
Mean (Standard Deviation) [units on a scale]	0.71 (0.40)	0.63 (0.39)

18. Secondary Outcome

Title	Limbal Conjunctiva Hyperaemia
Description	Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection)
Time Frame	4-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one month in this cross-over study. Test lens: Contact lens	Subjects were randomized to wear control contact lens for one month in this cross-over study. Control lens: Contact lens
Measure Participants	46	46
Mean (Standard Deviation) [units on a scale]	0.65 (0.42)	0.76 (0.35)

Adverse Events

Time Frame	From dispense up to 4-weeks on each type of lenses
Arm/Group Title	Test Lens		Control Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one month in this cross-over study. Test lens: Contact lens		Subjects were randomized to wear control contact lens for one month in this cross-over study. Control lens: Contact lens
All Cause Mortality
	Test Lens		Control Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/46 (0%)
Serious Adverse Events
	Test Lens		Control Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/46 (0%)
Other (Not Including Serious) Adverse Events
	Test Lens		Control Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/46 (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.