N/A
N=53
Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers
Myopia · Hyperopia
Bottom Line
View on ClinicalTrials.gov: NCT06098339 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Lens Handling on Removal — 84; 89 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lens A (fanfilcon A) (Device); Lens B (lotrafilcon B) (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Handling on Removal |
84; 89 | — |
Summary
The purpose of this study was to compare the clinical performance of two different reusable lenses in habitual spherical soft lens wearers.
Eligibility Criteria
Inclusion Criteria
- Were at least 18 years of age and no older than 39 years, and had full legal capacity to volunteer;
- Had read and signed an information consent letter;
- Were willing and able to follow instructions and maintain the appointment schedule;
- Self-reported having had a full eye examination in the previous two years;
- Had healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;
- Anticipated being able to wear the study lenses for at least 8 hours a day, 6 days a week;
- 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;
- Had refractive astigmatism no higher than -0.75DC in each eye;
- 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
- Were participating in any concurrent clinical or research study;
- Had any known active ocular disease and/or infection that contraindicated contact lens wear;
- Had a systemic or ocular condition that in the opinion of the investigator may have affected a study outcome variable;
- 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;
- Had known sensitivity to the diagnostic sodium fluorescein used in the study;
- Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
- Had undergone refractive error surgery or intraocular surgery.
Data sourced from ClinicalTrials.gov (NCT06098339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.