The Effects of Contact Lenses With Experimental Dye on Visual Function
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 10/20/2018 |
Start Date: | May 15, 2018 |
End Date: | September 20, 2018 |
This is a single-site, two-visit, contralateral, non-dispensing, randomized, controlled and
subject-masked study to measure potential benefits of the new UV blocker.
subject-masked study to measure potential benefits of the new UV blocker.
Inclusion Criteria:
- Potential subjects must satisfy all of the following criteria to be enrolled in the
study:
1. The subject must 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. Between 18 and 65 (inclusive) years of age at the time of screening.
4. Be a current spherical soft silicone hydrogel contact lens wearer in both eyes with a
minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.
5. The subject's vertex-corrected spherical equivalent distance refraction must be in the
range of -1.00 through -4.50 D in each eye.
6. The subject has a best corrected visual acuity of 20/25 or better in each eye.
Exclusion Criteria:
1. Currently pregnant or breastfeeding.
2. Any ocular or systemic allergies or diseases that may interfere with contact lens
wear.
3. Any autoimmune disease or use of medication, which may interfere with contact lens
wear. Habitual medications used by successful soft contact lens wearers are considered
acceptable.
4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of
recurrent corneal erosions, or aphakia.
5. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK,
LASIK, etc.).
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact
lens wear.
7. Multifocal, toric or extended wear contact lens correction.
8. Participation in any contact lens or lens care product clinical trial within 14 days
prior to study enrollment.
9. History of binocular vision abnormality or strabismus.
10. Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive
diseases (e.g., HIV) by self-report.
11. Employee or immediate family member of an employee of clinical site (e.g.,
Investigator, Coordinator, Technician).
12. Any ocular infection.
13. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization,
corneal staining, tarsal abnormalities, conjunctival injection) on the FDA
classification scale, any previous history or signs of a contact lens-related corneal
inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any
other ocular abnormality that may contraindicate contact lens wear.
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