Status:
COMPLETED
Comparison of Clinical Performance of Two Monthly Replacement Toric Soft Contact Lenses
Lead Sponsor:
Alcon Research
Conditions:
Ametropia
Astigmatism
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief 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.
Detailed Description
Subjects will be expected to attend 5 office visits and will be dispensed study lenses (per randomization sequence) for 30-day duration of bilateral wear with each study lens (approximately 60 days of...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
January 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2024
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT06165627
Start Date
January 23 2024
End Date
May 12 2024
Last Update
May 29 2025
Active Locations (5)
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1
Kurata Eye Care Center
Los Angeles, California, United States, 90012
2
Elsa Pao, OD
Oakland, California, United States, 94607
3
Pacific Rims Optometry
San Francisco, California, United States, 94127
4
Vision Health Institute
Orlando, Florida, United States, 32803