Design Validation of Senofilcon A With New UV-blocking Additive
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - 49 |
Updated: | 11/16/2018 |
Start Date: | October 1, 2018 |
End Date: | November 1, 2018 |
This is a 2-visit, multi-site, partially subject-masked, 2-arm parallel, controlled,
randomized and dispensing trial. Subjects will be randomized to one of two study lenses for
the entire duration of the study. The study lenses will be worn for a period of 2 weeks each
in a bilateral fashion.
randomized and dispensing trial. Subjects will be randomized to one of two study lenses for
the entire duration of the study. The study lenses will be worn for a period of 2 weeks each
in a bilateral fashion.
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 49 (inclusive) years of age at the time of informed consent.
4. Eligible presbyopes will be those that wear full distance contact lenses in both
eyes, then wear reading glasses over them when needed for near vision.
5. The subject is a current spherical soft 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.
6. Subjects must be able and willing to wear the study lenses at least 6 hours a
day, a minimum of 5 days per week.
7. Subjects must own a wearable pair of distance spectacles.
8. The subject's vertex-corrected spherical equivalent distance refraction must be
in the range of -1.00 to -6.00 D (inclusive) in each eye.
9. The subject's refractive cylinder must be 0.00 to -1.00 D (inclusive) in each
eye.
10. The subject must have a spherocylindrical best corrected distance Snellen visual
acuity of 20/25+3 or better in each eye.
Exclusion Criteria:
- Potential subjects who meet any of the following criteria will be excluded from
participating in the study:
1. Currently pregnant or lactating (subjects who become pregnant during the study
will be discontinued).
2. Any active or ongoing systemic disease (e.g., Sjögren's Syndrome), infectious
disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases
(e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis).
3. Subjects taking suspect oral medications for less than one year.
4. Any prescribed or over the counter (OTC) ocular medication.
5. Any known hypersensitivity or allergic reaction to Optifree® PureMoist®
multi-purpose care solution or Eye-Cept® rewetting drop solution.
6. Toric, extended wear, monovision or multi-focal contact lens correction.
7. Any previous or planned (during the course of the study) ocular surgery (e.g.,
PRK, LASIK, etc.).
8. Participation in any contact lens or lens care product clinical trial within 30
days prior to study enrollment.
9. Participation in clinical trials involving the Test lens within 3 months prior to
study enrollment.
10. Employee or immediate family member of an employee of clinical site (e.g.,
Investigator, Coordinator, Technician).
11. Binocular vision abnormality or strabismus by self-report or prior medical
history.
12. History of recurrent corneal erosions, herpetic keratitis, or pathological dry
eye.
13. Any active ocular allergies, infections or other ocular abnormalities (entropion,
ectropion, extrusions, chalazia, recurrent styes, glaucoma) that the investigator
determines may interfere with the outcomes of this study or otherwise
contraindicate participation in the study.
14. Any Grade 2 or greater slit lamp findings (e.g., edema, corneal
neovascularization, corneal staining, tarsal abnormalities, conjunctival
injection) on the FDA Slit Lamp Classification Scale.
15. Any previous history or signs of a contact lens-related corneal inflammatory
event (e.g., past peripheral ulcer or round peripheral scar) within the past 3
years of otherwise successful contact lens wear.
We found this trial at
10
sites
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