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NCT00598689 · ClinicalTrials.gov registry record · Phase 4
GenTeal in Perioperative Treatment of Laser Assisted in Situ Keratomileusis LASIK Patients
A Phase 4 study of Corneal Epithelium Defect, sponsored by Augusta University.
- Completed
- Registry status
- Phase 4
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT00598689: Completed Phase 4 study of Corneal Epithelium Defect, sponsored by Augusta University.
NCT00598689 is a Phase 4 study of Corneal Epithelium Defect that has completed, run by Augusta University. The registered enrollment target is 80 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00598689, a Phase 4 study of Corneal Epithelium Defect, has completed, sponsored by Augusta University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Assess whether preoperative GenTeal Gel enhances epithelial healing after LASIK surgery within the first post-operative week, compared to control (no preoperative lubricant). Healing of the area of the cornea covering the radius of the sectioned into clock hours 0 - 12 where 0 hours equals no healing and 12 hours equals complete healing.
Conditions Studied
Interventions
- DRUG 0.3% hypromellose
Study Locations (1)
Georgia
- EyeCare One - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-10 |
| Phase | Phase 4 |
What the finished NCT00598689 record still lists
NCT00598689 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Corneal Epithelium Defect appearing as the primary indexed condition, and to 1 intervention - of which 0.3% hypromellose is the first listed.
NCT00598689 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT00598689 about?
NCT00598689 is a clinical study titled "GenTeal in Perioperative Treatment of Laser Assisted in Situ Keratomileusis LASIK Patients". 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...
What is the current status of trial NCT00598689?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 80 participants. The study started on 2007-10. Estimated completion is 2009-10.
What conditions does trial NCT00598689 study?
This clinical trial studies the following conditions: Corneal Epithelium Defect.
What interventions are being tested in trial NCT00598689?
The interventions under investigation include: 0.3% hypromellose (DRUG).
Who is sponsoring clinical trial NCT00598689?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00598689 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00598689's enrollment target sits among peer trials
80 946th of 2000 higher than 1,022 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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