Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03226353
• Date of registration: 18/07/2017
• Prospective Registration: No
• Primary sponsor: Coopervision, Inc.
• Public title: Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A
• Scientific title: Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A
• Date of first enrolment: July 6, 2017
• Target sample size: 77
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03226353
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada

Key inclusion & exclusion criteria

Inclusion Criteria:

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

- Has read and signed an information consent letter;

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

- Habitually wears soft spherical contact lenses with a power between +6.00 to -10.00D
(inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no
difficulty wearing contact lenses for 7 days per week, 10 hours per day;

- Habitually wears, or is able to be adequately refit into Proclear 1 Day lenses;

- Demonstrates an acceptable fit with Proclear 1 Day and Clariti 1 Day contact lenses;

- Is correctable to a visual acuity of 0.20 LogMAR (approximately 20/30) or better (in
each eye) with the study lenses or habitual correction;

- Manifest cylindrical spectacle refraction does not exceed -1.00DC in either eye.

Exclusion Criteria:

- Is participating in any concurrent clinical research study;

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

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

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

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

- Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal
communication);

- Is aphakic;

- Has undergone refractive error surgery;

- Is an employee of the Centre for Contact Lens Research;

- Has taken part in another clinical or (pharmaceutical) research study within the last
7 days.



Age minimum: 17 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Myopia

Intervention(s)

Device: omafilcon A

Device: somofilcon A

Primary Outcome(s)

Overall Lens Fit Acceptance [Time Frame: Dispense and 1 Week]

Lens Fit - Lens Deposition [Time Frame: Dispense and 1 week]

Lens Fit - Centration [Time Frame: Dispense and 1 Week]

Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day? [Time Frame: 1 week]

Lens Fit - Lens Wettability [Time Frame: Dispense and 1 Week]

Lens Fit - Post-blink Lens Movement [Time Frame: Dispense and 1 Week]

Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A? [Time Frame: 1 week]

Investigator Assessment to Refit- Based on the Investigator Opinion and Lens Fit Outcomes, Would the Investigator Refit the Subject Into Somofilcon A From Omafilcon A? [Time Frame: 1 week]

Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A? [Time Frame: 1 week]

Lens Fit - Lens Tightness [Time Frame: Dispense and 1 week]

Secondary ID(s)

EX-MKTG-84

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/02/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03226353