NCT00598689

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

March 7, 2016

Completed
Last Updated

March 7, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

January 10, 2008

Results QC Date

January 27, 2015

Last Update Submit

February 10, 2016

Conditions

Corneal Epithelium Defect

Keywords

LASIKOcular LubricantsCorneal EpitheliumWound Healing

Outcome Measures

Primary Outcomes (1)

  • Epithelial Healing After Laser Assisted in Situ Keratomileusis (LASIK) Surgery

    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.

    Day 1, End of Week 1

Secondary Outcomes (2)

  • Post Operative Pain Level

    Day 1, End of Week 1

  • Tolerability and Alleviation of Post-operative Pain in LASIK Surgery

    Week 1 post surgery

Study Arms (2)

Lubricant

EXPERIMENTAL

Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.

Drug: 0.3% hypromellose

No Lubricant

NO INTERVENTION

Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery

Interventions

0.3% hypromelloseDRUG

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

Also known as: Genteal Gel
Lubricant

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EyeCare One

Augusta, Georgia, 30907, United States

Location

Related Publications (1)

  • Samuel MA, Kaufman SC, Ahee JA, Wee C, Bogorad D. Diffuse lamellar keratitis associated with carboxymethylcellulose sodium 1% after laser in situ keratomileusis. J Cataract Refract Surg. 2002 Aug;28(8):1409-11. doi: 10.1016/s0886-3350(02)01266-x.

    PMID: 12160811BACKGROUND

MeSH Terms

Interventions

Hypromellose Derivatives

Intervention Hierarchy (Ancestors)

CelluloseGlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
David D. Bogorad, MD, FACS
Organization
Georgia Regents University
dbogorad@gru.edu
706-721-1160

Study Officials

  • David D Bogorad, M.D

    Augusta University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Vice Chairman, Director, Refractive Surgery Service, Department of Ophthalmology

Study Record Dates

First Submitted

January 10, 2008

First Posted

January 22, 2008

Study Start

October 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

March 7, 2016

Results First Posted

March 7, 2016

Record last verified: 2016-02

Locations

US(1)