ISRCTN11194798
Completed
未知
Crossover evaluation of Clinitas Soothe® eye drops in symptomatic soft contact lens wearers (part 1)
CooperVision Inc. (USA)0 sites15 target enrollmentMarch 1, 2019
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CooperVision Inc. (USA)
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. \=18 years of age
- •2\. Adapted and current symptomatic soft CL wearers (i.e. \>1 month of wear)
- •3\. Spherical spectacle prescription between \+6\.00 and \-10\.00D (inclusive)
- •4\. Correctable to 6/12 (20/40\) or better in each eye
- •5\. Require visual correction in both eyes (monovision allowed but no monofit)
- •6\. Have normal eyes with no evidence of any ocular abnormality or disease.
Exclusion Criteria
- •1\. Previously shown sensitivity to any of the study solutions’ components.
- •2\. Any systemic or ocular disease or allergies affecting ocular health.
- •3\. Using systemic or topical medications that will, in the investigator’s opinion, affect ocular physiology or lens performance.
- •4\. Clinically significant (\>Grade 3\) corneal stromal edema, corneal vascularisation, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
- •5\. Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea.
- •6\. Keratoconus or other corneal irregularity.
- •7\. Aphakia or amblyopia.
- •8\. Has diabetes.
- •9\. Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
- •10\. History of chronic eye disease (e.g. glaucoma or ARMD).
Outcomes
Primary Outcomes
Not specified
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