Comparison of Clinical Performance of Two Monthly Replacement Toric Soft Contact Lenses (NCT06165627) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Clinical Performance of Two Monthly Replacement Toric Soft Contact Lenses
United States67 participantsStarted 2024-01-23
Plain-language summary
The purpose of this study is to assess the clinical performance of TOTAL30 for Astigmatism (T30fA) soft contact lenses with Biofinity Toric soft contact lenses.
Who can participate
Age range18 Years – 45 Years
SexALL
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Key Inclusion Criteria:
* Successful wearer of toric soft contact lenses in both eyes for a minimum of 5 days per week and at least 12 hours per day during the past 3 months;
* Best corrected distance visual acuity (as determined by manifest refraction at screening) better than or equal to 0.10 logMAR in each eye;
* Willing and able to wear the study lenses as specified in the protocol;
* Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
* Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher; presence of corneal infiltrates;
* Monovision and multifocal contact lens wearers;
* Habitual Biofinity Toric soft contact lens wearers, daily disposable contact lens wearers, and Alcon Toric contact lens wearers in the past 3 months prior to consent;
* Wearing habitual contact lenses in extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
* Other protocol-specified exclusion criteria may apply.
What they're measuring
1
Mean Distance Visual Acuity With Study Lenses at Day 30
Timeframe: Day 30 of each wear period. A wear period was 30 days [-1/+3 days] according to randomization assignment.