Clinical trial NCT03226353: Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A
Official title: Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2017-07-21
Enrollment: 77
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to determine if habitual or adapted contact lens wearers of Omafilcon A can be confidently refit into Somofilcon A lenses and be successful after one week of daily wear.

The primary outcome variables for this study are:

* Investigator responses to refit questions;
* Lens fit.

Detailed description: This is a prospective, single-site, dispensing, bilateral wear, open label, daily wear switch study, with the test lens (Somofilcon A) being worn for 7 (+5) days.

Eligibility 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.

Primary outcomes:
measure: Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A?
timeFrame: 1 week
measure: 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?
timeFrame: 1 week
measure: Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day?
timeFrame: 1 week
measure: Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A?
timeFrame: 1 week
measure: Lens Fit - Post-blink Lens Movement
timeFrame: Dispense and 1 Week
measure: Lens Fit - Lens Tightness
timeFrame: Dispense and 1 week
measure: Lens Fit - Lens Deposition
timeFrame: Dispense and 1 week
measure: Lens Fit - Centration
timeFrame: Dispense and 1 Week
measure: Lens Fit - Lens Wettability
timeFrame: Dispense and 1 Week
measure: Overall Lens Fit Acceptance
timeFrame: Dispense and 1 Week
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Center for Contact Lens Research, University of Waterloo
state: Ontario
Study officials:
References: