CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 80 enrolled
Drug / intervention
0.3% hypromellosedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00598689
NCT00598689Phase 4Completed

Efficacy, Tolerability and Comfort of GenTeal and GenTeal Gel, (0.3% Hypromellose) in the Pre- and Post- Operative Treatment of Patients Undergoing LASIK Surgery

Augusta University·interventional·Posted Jan 22, 2008·Updated Mar 7, 2016

In Brief

A Phase 4 clinical trial evaluating 0.3% hypromellose for Corneal Epithelium Defect. Completed, enrolled 80 participants across 1 site.

Detailed Summary

GenTeal gel is an artificial tear gel used to lubricate the surface of the eye. This study will evaluate the effect of GenTeal gel on comfort following LASIK surgery. Participants will be asked to come to the clinic for three regularly scheduled visits after LASIK surgery: Day 1 (one day after LASIK surgery), Day 7 (one week follow-up), and Day 30 (one month follow-up). Participants will be asked to complete a questionnaire regarding eye comfort during each follow up visit. Participants will be randomly assigned to one of two groups, one of which will receive Genteal Gel four times a day for five days prior to surgery. The other group will receive no preoperative gel or lubricant, which has been our standard approach for many years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsNovartis

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 22, 2008
Enrollment StartOct 1, 2007
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 18.4 years ago

Interventions

0.3% hypromellosedrug

0.3% hypromellose four times a day for 5 days prior to LASIK surgery