Clinical trial NCT06098339: Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers
Official title: Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Hyperopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
Collaborators: name: Centre for Ocular Research & Education, Canada
First posted: 2023-10-24
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the clinical performance of two different reusable lenses in habitual spherical soft lens wearers.

Detailed description: This study was a prospective, bilateral eye, double-masked, randomized, 1 month cross-over, daily-wear design involving two different frequent replacement type lenses. Duration of involvement for each participant was approximately 3 months.

Eligibility criteria: Inclusion Criteria:

1. Were at least 18 years of age and no older than 39 years, and had full legal capacity to volunteer;
2. Had read and signed an information consent letter;
3. Were willing and able to follow instructions and maintain the appointment schedule;
4. Self-reported having had a full eye examination in the previous two years;
5. Had healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;
6. Anticipated being able to wear the study lenses for at least 8 hours a day, 6 days a week;
7. Habitually wore spherical soft contact lenses, for the past 3 months minimum:

   It was preferred that all participants were habitual frequent replacement lens wearers. However, if this was not possible then no more than 5 participants could be habitual daily disposable lens wearers at each site, the rest had to be habitual frequent replacement lens wearers;

   - For the frequent replacement wearers: No more than 3 could be habitual wearers of the Avaira Vitality™/ Serenity™ brand (or their equivalent private label brand name) and no more than 3 could be habitual wearers of AIR OPTIX® plus HydraGlyde® can be enrolled at each site;
8. Had refractive astigmatism no higher than -0.75DC in each eye;
9. Could be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere +6.00 to -6.00D, 0.25D steps).

Exclusion Criteria:

1. Were participating in any concurrent clinical or research study;
2. Had any known active ocular disease and/or infection that contraindicated contact lens wear;
3. Had a systemic or ocular condition that in the opinion of the investigator may have affected a study outcome variable;
4. Were using any systemic or topical medications that in the opinion of the investigator may have affect contact lens wear or a study outcome variable;
5. Had known sensitivity to the diagnostic sodium fluorescein used in the study;
6. Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
7. Had undergone refractive error surgery or intraocular surgery.

Primary outcomes:
measure: Lens Handling on Removal
timeFrame: Day 27
Secondary outcomes:
Other outcomes:
Locations:
city: Ocoee
country: United States
facility: Coan Eye Care
state: Florida
city: State College
country: United States
facility: Nittany Eye Associates
state: Pennsylvania
city: Waterloo
country: Canada
facility: Insight Eye Care
state: Ontario
Study officials:
affiliation: Insight Eye Care
name: Carolyn MacNeil
role: PRINCIPAL_INVESTIGATOR
affiliation: Nittany Eye Associates
name: Abigail Gillogly-Harsch
role: PRINCIPAL_INVESTIGATOR
affiliation: Coan Eye Care
name: Roxanne Achong-Coan
role: PRINCIPAL_INVESTIGATOR
References: