Efficacy, Tolerability, and Comfort of 0.3% Hypromellose Eyedrops in Patients Undergoing LASIK Surgery

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to assess the tolerability and comfort of peri-operative 0.3% hypromellose eye drops in LASIK surgery patients and to assess whether pre-operative 0.3% hypromellose eye drops add to post-operative comfort in LASIK surgery patients compared to control (no pre-operative lubricant).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis; Novartis Pharmaceuticals
• Treatments: Ophthalmic Solutions

Criteria

Inclusion Criteria:

• Age 21 - 35

• Both sexes

• Seeking LASIK surgery at the Refractive Surgery Centre

• Meeting all established criteria for appropriateness for LASIK established by the treating center

Exclusion Criteria:

• Any corneal pathology including scars, prior herpes keratitis, prior corneal transplant

• Any immuno-compromised state including cancer, HIV infection, Hepatitis B or C, or diabetes mellitus

• Requirement for any eye-drops for any reason (eg, dry eye or conjunctivitis) within 3 months from time of enrollment

• Anticipated refusal or inability to undergo planned post-operative visits or assessment

• Failure to meet all established criteria for appropriateness for LASIK