One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/24/2017 |
Start Date: | August 14, 2017 |
End Date: | December 20, 2017 |
The purpose of this study is to evaluate the clinical performance of the contact lens care
product Oté Sensation in a representative population of soft contact lens wearers. For
comparison, a widely used FDA approved soft lens multipurpose solution will be used as a
control. This control product has been tested in previous clinical trials.
product Oté Sensation in a representative population of soft contact lens wearers. For
comparison, a widely used FDA approved soft lens multipurpose solution will be used as a
control. This control product has been tested in previous clinical trials.
This will be a 1-month, 200-subject, double-masked (care product), bilateral, randomized,
comparative study. Subjects will be clinically evaluated at the initial baseline visit (Visit
1), then after 1 week and 1 month of lens wear having been randomly assigned to use one of
six lens types and to either the test or control solutions.
comparative study. Subjects will be clinically evaluated at the initial baseline visit (Visit
1), then after 1 week and 1 month of lens wear having been randomly assigned to use one of
six lens types and to either the test or control solutions.
Inclusion Criteria:
- Be a currently adapted soft contact lens wearer (>1 month of lens wear).
- Be at least 18 years of age.
- Refractive astigmatism <0.75 D in both eyes.
- Have clear corneas and be free of any anterior segment disorders.
- Be correctable through spherocylindrical refraction to 6/12 (20/40) (0.30 LogMAR) or
better in each eye.
- Contact lens sphere requirement between +4.00 Dioptre and -8.00 D (inclusive).
- Require visual correction in both eyes (monovision allowed, no monofit).
- Have normal eyes with no evidence of abnormality or disease. For the purposes of this
study a normal eye is defined as one having:
1. No amblyopia
2. No strabismus
3. No evidence of lid abnormality or infection
4. No conjunctival abnormality or infection that would contraindicate contact lens
wear
5. No clinically significant slit lamp findings (i.e. corneal staining, stromal
edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
6. No other active ocular disease.
Exclusion Criteria:
- Require toric or multifocal contact lenses.
- Previously shown a sensitivity to any of the study solution components.
- Any systemic or ocular disease or allergies affecting ocular health.
- Using systemic or topical medications that will in the investigator's opinion affect
ocular physiology or lens performance.
- Clinically significant (>Grade 3) corneal staining, corneal stromal edema, corneal
vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any
other abnormality of the cornea that would contraindicate contact lens wear.
- Any corneal infiltrates or any corneal scarring or neovascularization within the
central 5mm of the cornea.
- Keratoconus or other corneal irregularity.
- Aphakia or amblyopia.
- Have undergone corneal refractive surgery or any anterior segment surgery.
- Abnormal lacrimal secretions.
- Has diabetes.
- Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an
immunosuppressive disease (e.g., HIV).
- History of chronic eye disease (e.g. glaucoma).
- Pregnant or lactating or planning a pregnancy at the time of enrolment.
- Participation in any concurrent clinical trial or in last 30 days.
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