Short-term evaluation of a commercial eyedrop in contact lens wearers

Not Applicable

Completed

• Conditions: /A; Not Applicable

• Registration Number: ISRCTN11194798
• Lead Sponsor: CooperVision Inc. (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-08-07
• Study Start: 2019-03-01
• Last Update Posted: 1 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

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).
11. Pregnant or lactating or planning a pregnancy at the time of enrolment.
12. Participation in any concurrent clinical trial or in last 14 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified