Evaluation of Daily Disposable Toric Soft Lenses Manufactured With an Alternative Hydration Process (NCT06967129) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Daily Disposable Toric Soft Lenses Manufactured With an Alternative Hydration Process
United States281 participantsStarted 2025-04-25
Plain-language summary
This is a prospective, multi-site, dispensing, randomized, controlled, double-masked, bilateral wear, 2x2 crossover study to evaluate the safety and effectiveness of the test lens.
Who can participate
Age range18 Years – 39 Years
SexALL
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Potential subjects must satisfy all of the following criteria to be enrolled in the study:
1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Be between 18 and 39 (inclusive) years of age at the time of screening.
4. By self-report, habitually wear soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 2 days per week during last 30 days.
5. Possess a wearable pair of spectacles that provide correction for distance vision.
6. In both eyes, have astigmatic refractive error suitable for correction with the toric contact lens powers available in this study:
1. Sphere powers (DS) -1.50 through -4.00 (inclusive) in 0.25 steps
2. Cylinder powers (DC) -0.75 and -1.25
3. Axes (°) 170, 180, 10, 80, 90, 100
7. Have best corrected monocular distance visual acuity of 20/30 or better in each eye.
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
1. Be currently pregnant or lactating.
2. Be diabetic.
3. Be currently using any ocular medications or have an ocular infection of any type.
4. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfer…
What they're measuring
1
Distance (4m) Monocular High Luminance High Contrast (HLHC) logMAR Visual Acuity (VA)
Timeframe: At each 1-week follow-up per wear period
2
Toric Lens Orientation
Timeframe: At baseline per wear period
3
Lens Rotational Stability with Blinks
Timeframe: At baseline per wear period
4
Percentage of eyes with Grade 3 or higher SLFs relating to the test lens
Timeframe: Up to 3-week follow-up
5
Percentage of eyes with acceptable lens fitting while wearing the test lens