Trial Outcomes & Findings for Clinical Evaluation of 3 Contact Lens Materials With 3 Solution Types (NCT NCT03466060)

Last Updated: 2019-10-02

Results Overview

Subjective assessment of initial comfort was conducted using Visual Analogue Scale (VAS) of comfort. VAS of comfort consists of a vertical line which represents continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). VAS comfort was measured at 1-min, 5-min, 45-min, and 2-hours post-fit. The average comfort score for each solution was reported. This is a contralateral crossover, subject used the revitalens solution in one eye throughout the entire study therefore there are twice as many observations for revitalens compared to the other solutions.

Recruitment status

COMPLETED

Study phase

Target enrollment

130 participants

Primary outcome timeframe

Up to 2-Hours Post Lens Fitting

Results posted on

2019-10-02

Participant Flow

A total of 130 subjects were enrolled into this study. Of those enrolled, 113 subjects were assigned and dispensed a study lens while, 15 subjects were screen failures and 2 subjects were assigned but not administered the Test article. Of those dispensed, 106 subjects completed the study while, 7 subjects were discontinued.

Of those that completed the study, 78 subjects completed without a major protocol deviation impacting a primary endpoint.

Participant milestones

Participant milestones
Measure	Etafilcon A-Opti-Free/Clear Care Subjects that were dispensed the etafilcon A lens throughout the entire study and received Opti-Free in one eye during first period and Clear in one eye during second period. During both periods Revitalens was received on the contralateral eye.	Etafilcon A-Clear Care/Opti-Free Subjects that were dispensed the etafilcon A lens throughout the entire study and received Clear Care in one eye during first period and Opti-Free in one eye during second period. During both periods Revitalens was received on the contralateral eye.	Senofilcon A-Opti-free/Clear Care Subjects that were dispensed the senofilcon A lens throughout the entire study and received Opti-Free in one eye during first period and Clear Care in one eye during second period. During both periods Revitalens was received on the contralateral eye.	Senofilcon A-Clear Care/Opti-Free Subjects that were dispensed the senofilcon A lens throughout the entire study and received Clear Care in one eye during first period and Opti-Free in one eye during second period. During both periods Revitalens was received on the contralateral eye.	Senofilcon C-Opti-Free/Clear Care Subjects that were dispensed the senofilcon C lens throughout the entire study and received Opti-Free in one eye during first period and Clear Care in one eye during second period. During both periods Revitalens was received on the contralateral eye.	Senofilcon C-Clear Care/Opti-Free Subjects that were dispensed the senofilcon C lens throughout the entire study and received Clear Care in one eye during first period and Opti-Free in one eye during second period. During both periods Revitalens was received on the contralateral eye.
Period 1 STARTED	19	18	20	18	20	18
Period 1 COMPLETED	19	16	17	17	20	18
Period 1 NOT COMPLETED	0	2	3	1	0	0
Period 2 STARTED	19	16	17	17	20	18
Period 2 COMPLETED	19	16	16	17	20	18
Period 2 NOT COMPLETED	0	0	1	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Etafilcon A-Clear Care/Opti-Free Subjects that were dispensed the etafilcon A lens throughout the entire study and received Clear Care in one eye during first period and Opti-Free in one eye during second period. During both periods Revitalens was received on the contralateral eye.	Senofilcon A-Opti-free/Clear Care Subjects that were dispensed the senofilcon A lens throughout the entire study and received Opti-Free in one eye during first period and Clear Care in one eye during second period. During both periods Revitalens was received on the contralateral eye.	Senofilcon A-Clear Care/Opti-Free Subjects that were dispensed the senofilcon A lens throughout the entire study and received Clear Care in one eye during first period and Opti-Free in one eye during second period. During both periods Revitalens was received on the contralateral eye.
Period 1 Test Lens Damage	2	0	0
Period 1 Withdrawal by Subject	0	2	0
Period 1 Lost to Follow-up	0	0	1
Period 1 Grade 2 Conjunctivitis	0	1	0
Period 2 Lens Handling Difficulties	0	1	0

Baseline Characteristics

Clinical Evaluation of 3 Contact Lens Materials With 3 Solution Types

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etafilcon A n=37 Participants Subjects that wore the etafilcon A lens during the entire study.	Senofilcon A n=38 Participants Subjects that wore the senofilcon A lens during the entire study.	Senofilcon C n=38 Participants Subjects that wore the senofilcon C lens during the entire study.	Total n=113 Participants Total of all reporting groups
Age, Continuous	28.1 Years STANDARD_DEVIATION 9.41 • n=5 Participants	27.7 Years STANDARD_DEVIATION 7.82 • n=7 Participants	29.1 Years STANDARD_DEVIATION 10.52 • n=5 Participants	28.3 Years STANDARD_DEVIATION 9.25 • n=4 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	30 Participants n=7 Participants	27 Participants n=5 Participants	77 Participants n=4 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants	36 Participants n=4 Participants
Race/Ethnicity, Customized Asian	11 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants	33 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Island	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White	22 Participants n=5 Participants	20 Participants n=7 Participants	24 Participants n=5 Participants	66 Participants n=4 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment United States	37 Participants n=5 Participants	38 Participants n=7 Participants	38 Participants n=5 Participants	113 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 2-Hours Post Lens Fitting

Population: All subjects who successfully completed all study visits without a major protocol deviation.

Outcome measures

Outcome measures
Measure	Revita- Lens n=78 Eyes All subject eyes that wore contact lenses pre-soaked in Revita-lens solution up to 2 hours regardless of the lens type.	Clear Care n=78 Eyes All subject eyes that wore contact lenses pre-soaked in Clear Care solution up to 2 hours regardless of the lens type.	Opti-Free n=78 Eyes All subjects eyes that wore contact lenses pre-soaked in Opit-Free solution up to 2 hours regardless of the lens type.
Subject Comfort 1-Minute Follow-up	92.4 Units on a scale Standard Deviation 11.74	92.4 Units on a scale Standard Deviation 10.52	92.0 Units on a scale Standard Deviation 10.58
Subject Comfort 5-Minute Follow-up	63.0 Units on a scale Standard Deviation 10.17	93.4 Units on a scale Standard Deviation 8.90	92.3 Units on a scale Standard Deviation 9.81
Subject Comfort 45 Minute Follow-up	93.5 Units on a scale Standard Deviation 9.48	93.7 Units on a scale Standard Deviation 8.44	93.5 Units on a scale Standard Deviation 7.96
Subject Comfort 2-Hour Follow-up	94.7 Units on a scale Standard Deviation 7.06	94.6 Units on a scale Standard Deviation 7.32	94.3 Units on a scale Standard Deviation 7.39

Additional Information

Meredith Bishop, OD, MS, FAAO- Senior Principal Research Optometrist

Johnson & Johnson Vision Care Inc.

Phone: 904-443-1396

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60