Status:
COMPLETED
Clinical Evaluation of a Silicone Hydrogel Daily Wear Monthly Replacement Contact Lens
Lead Sponsor:
Alcon Research
Conditions:
Refractive Errors
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this clinical study is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear mo...
Detailed Description
Subjects will be expected to attend 4 office visits: Screening/Baseline/Dispense, Week 1 Follow-up, Month 1 Follow-up, and Month 3 Follow-up/Exit. The total expected duration of participation for each...
Eligibility Criteria
Inclusion
- Key
- Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day;
- Manifest cylinder equal to or less than 0.75 diopter (D) in each eye;
- Best spectacle corrected visual acuity (using manifest refraction) of 20/20 or better in each eye;
- Other protocol-defined inclusion criteria may apply.
- Key
Exclusion
- Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
- Habitually wearing Biofinity lenses;
- Monovision or multifocal contact lens wearers;
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2021
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT04422990
Start Date
October 1 2020
End Date
May 18 2021
Last Update
March 29 2022
Active Locations (14)
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1
Alcon Investigative Site
Los Angeles, California, United States, 90012
2
Alcon Investigative Site
Novato, California, United States, 94945
3
Alcon Investigative Site
Oakland, California, United States, 94513
4
Alcon Investigative Site
Oakland, California, United States, 94607