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

Novartis

Status and phase: Completed; Phase 4

Conditions: Dry Eye

Treatments: Drug: Post-LASIK 0.3% hypromellose; Drug: Pre-LASIK 0.3% hypromellose

Study type: Interventional

Funder types: Industry

Identifiers

NCT00909324

CGET980AIN03

Details and patient eligibility

About

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).

Enrollment: 170 patients

Sex: All

Ages: 21 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Pre-LASIK 0.3% hypromellose

Experimental group

Treatment:

Drug: Pre-LASIK 0.3% hypromellose

Post-LASIK 0.3% hypromellose

Active Comparator group

Treatment:

Drug: Post-LASIK 0.3% hypromellose