N/A
N=26
To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT05333965 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Lens Handling on Lens Removal — 8.4; 8.9 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lens A (lehfilcon A lens) (Device); Lens B (comfilcon A lens) (Device)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Handling on Lens Removal |
8.4; 8.9 | — |
Summary
To evaluate the performance of two monthly replacement silicone hydrogel contact lenses in habitual FRP CL wearers when worn for 1-month.
Eligibility Criteria
Inclusion Criteria
- Is at least 17 years of age and has full legal capacity to volunteer;
- Self-reports having had a full eye examination within the previous 2 years;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is a habitual wearer of frequent replacement contact lenses;
- Anticipates no difficulty wearing the contact lenses for 6 days/week and 8 hours/day during the study;
- Has refractive astigmatism no higher than -0.75DC in each eye;
- Can be successfully fit with both study lens types;
- Achieves at least 0.4 logMAR VA monocularly and at least 0.2 logMAR VA binocularly with each study lens type.
Exclusion Criteria
- Is participating in any concurrent clinical research study;
- Has any known active ocular disease and/or infection;
- Has an unstable systemic condition that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;
- Is using any systemic or topical medications in an irregular routine that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;
- Has known sensitivity to the diagnostic sodium fluorescein to be used in the study;
- Is an employee of the Centre for Ocular Research & Education.
Data sourced from ClinicalTrials.gov (NCT05333965). 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.