CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 170 enrolled
Drug / intervention
Pre-LASIK 0.3% hypromellose +1 moredrug
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/NCT00909324
NCT00909324Phase 4Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted May 28, 2009·Updated Aug 17, 2020

In Brief

A Phase 4 clinical trial evaluating Pre-LASIK 0.3% hypromellose and Post-LASIK 0.3% hypromellose for Dry Eye. Completed, enrolled 170 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye
CountriesIndia
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 28, 2009
Enrollment StartAug 1, 2009
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.1 years ago

Interventions

Pre-LASIK 0.3% hypromellosedrug

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.

Post-LASIK 0.3% hypromellosedrug

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.