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

NCT00909324 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2020-08-17

Study results available
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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).

Conditions

  • Dry Eye

Interventions

DRUG

Pre-LASIK 0.3% hypromellose

Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.

DRUG

Post-LASIK 0.3% hypromellose

Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

  • Novartis India Ltd. · Novartis India Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-01
Primary Completion
2010-01-01
Completion
2010-01-01

Countries

  • India

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00909324 on ClinicalTrials.gov