Phase 4 N=80 Randomized Single-blind Treatment

GenTeal in Perioperative Treatment of Laser Assisted in Situ Keratomileusis LASIK Patients

Corneal Epithelium Defect

Bottom Line

View on ClinicalTrials.gov: NCT00598689 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2016

Primary outcome: Primary: Epithelial Healing After Laser Assisted in Situ Keratomileusis (LASIK) Surgery — 4.3; 3.5; 9.2; 9.0 Clock Hours

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: 0.3% hypromellose (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Augusta University
Primary completion: Oct 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Epithelial Healing After Laser Assisted in Situ Keratomileusis (LASIK) Surgery	4.3; 3.5; 9.2; 9.0	—
SECONDARY Post Operative Pain Level	5.2; 5.4; 2.8; 3.1	—
SECONDARY Tolerability and Alleviation of Post-operative Pain in LASIK Surgery	80; 87.5; 20; 12.5	—

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.

Eligibility Criteria

Inclusion Criteria

Age 18 - 60
Both sexes
Any race
Seeking LASIK surgery at the Medical College of Georgia (MCG)/Eye Care One
Meeting all established criteria for appropriateness for LASIK established by MCG/Eye Care One

Exclusion Criteria

Any corneal pathology including scars, prior herpes keratitis, prior corneal transplant
Any immunocompromised state including diabetes mellitus, cancer, HIV infection, or Hepatitis B or C.
Failure to meet all established criteria for appropriateness for LASIK established by MCG/Eye Care One

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00598689). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.