Myopia Clinical Trial
Official title:
Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Toric Contact Lenses
Verified date | October 2023 |
Source | Alcon Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of this study is to evaluate the axis orientation of LID226397 toric contact lenses.
Status | Completed |
Enrollment | 92 |
Est. completion date | October 23, 2023 |
Est. primary completion date | October 23, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Key Inclusion Criteria: - Successful wearers of any commercial soft toric contact lenses (except AOfAHP and daily disposable lenses) in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day. - Able to be fit with and wear contact lenses within the available range of sphere & cylinder power and axes. - Best corrected distance visual acuity greater than or equal to 20/25 Snellen (0.10 logMAR) in each eye as determined by manifest refraction at screening. - Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: - 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. - Habitual AOfAHP contact lens wearers and habitual daily disposable lens wearers (worn within last 3 months). - Other exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
United States | Franklin Park Eye Center, PC | Franklin Park | Illinois |
United States | ProCare Vision Centers, Inc. | Granville | Ohio |
United States | Drs. Giedd, P.A. | Maitland | Florida |
United States | Optometry Group, PLLC | Memphis | Tennessee |
United States | Dr. Elsa Pao, OD | Oakland | California |
United States | Vision Health Institute | Orlando | Florida |
United States | Pacific Rims Optometry | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of lenses with axis orientation within ± 30 degrees from the intended axis at 10 minutes after lens insertion | The investigator will view the contact lens through a slit lamp (biomicroscope) and record the axis orientation (-179° to +180°) as the number of degrees away from the ideal location (90° axis) either positive or negative depending on the direction (nasal [+] or temporal [-]). | Day 1 Dispense, 10 minutes after lens insertion, for each wear period. Each wear period is approximately 14 days. |
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