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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00598689
Enrollment
80
Registered
2008-01-22
Start date
2007-10-31
Completion date
2009-10-31
Last updated
2016-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Epithelium Defect

Keywords

LASIK, Ocular Lubricants, Corneal Epithelium, Wound Healing

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.

Detailed description

LASIK (Laser Keratomileusis in Situ) is a frequently performed procedure to reduce the refractive error of the eye so as to minimize the subsequent need for eyeglasses or contact lenses. The procedure requires the creation of a superficial corneal flap, usually with an instrument known as a microkeratome. During the creation of the flap with a microkeratome, the corneal epithelium is typically subjected to sliding stresses which occasionally cause disruption of the epithelial surface, a complication with potentially serious adverse effect on the post operative visual acuity. As well, shortly before the creation of the flap, the patient is often dilated and invariably treated with topical anesthetics. These agents, and their preservatives, can have a negative effect on corneal epithelial integrity, right before the epithelium must withstand the passage of the microkeratome. Therefore, it is imperative that the epithelium be in the best possible condition prior to the LASIK procedure. For this reason, ocular lubricants may be used for a period of time prior to surgery in order to maximize epithelial health. In the immediate post-operative period the bond between the newly created flap and the underlying corneal stroma is weak, and the epithelium has just been subjected to the pharmacologic and mechanical stresses noted above. It is imperative that the surface continuity of the epithelium between the edge of the flap and the surrounding surface be restored as rapidly as possible, as reestablishment of an intact epithelial surface minimizes the risks of flap shift, epithelial ingrowth, and infection. For all these reasons, it is a generally accepted standard of care to use aggressive ocular lubrication during the post-operative period in order to maximize the speed of epithelial recovery. GenTeal Lubricant Eye Drops and GenTeal Gel, (0.3% hypromellose, Novartis Ophthalmics, Basel, Switzerland) provide a natural alternative to preservative-free treatments, with a sodium perborate preservative system and long-lasting action due to the carbomer gelling agent. The perborate preservative, which breaks down to water and oxygen on the ocular surface, essentially delivers a preservative-free lubricant to the eye. This makes the GenTeal products attractive agents for use in the LASIK perioperative period.

Interventions

DRUG0.3% hypromellose

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

Sponsors

Novartis
CollaboratorINDUSTRY
Augusta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age 18 - 60 2. Both sexes 3. Any race 4. Seeking LASIK surgery at the Medical College of Georgia (MCG)/Eye Care One 5. Meeting all established criteria for appropriateness for LASIK established by MCG/Eye Care One

Exclusion criteria

1. Any corneal pathology including scars, prior herpes keratitis, prior corneal transplant 2. Any immunocompromised state including diabetes mellitus, cancer, HIV infection, or Hepatitis B or C. 3. Failure to meet all established criteria for appropriateness for LASIK established by MCG/Eye Care One

Design outcomes

Primary

MeasureTime frameDescription
Epithelial Healing After Laser Assisted in Situ Keratomileusis (LASIK) SurgeryDay 1, End of Week 1Assess 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.

Secondary

MeasureTime frameDescription
Post Operative Pain LevelDay 1, End of Week 1Assess whether preoperative GenTeal Gel alleviates post operative pain in LASIK surgery patients compared to control (no preoperative lubricant) as measured by patient completion of the Universal Pain Assessment Tool (moderate), a ten point scale with 0 being no pain and 10 being the worst pain possible. Data on the level of pain only in the right eye will be collected.
Tolerability and Alleviation of Post-operative Pain in LASIK SurgeryWeek 1 post surgeryA comparison of subjective comfort level defined as tolerability and alleviation of post-operative pain experienced as a result of post-operative application of GenTeal drops. Subjective pain level was measured on a 10 point likert scale where 0 = no pain and 10 = worst pain possible. A lower score at Week 1 as compared to Day 1 was considered improved. A same score or higher at week 1 as compared to day 1 was considered no improvement.

Countries

United States

Participant flow

Recruitment details

80 subjects were recruited over a period of four months. Subjects were recruited from the pool of patient scheduled to have Laser Assisted in situ Keratomileusis (LASIK) surgery at the Medical College of Georgia/Eye Care One Laser Vision Center, Augusta, Georgia.

Pre-assignment details

Subjects were stratified based on smoking status.

Participants by arm

ArmCount
Lubricant
Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery. 0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery
40
No Lubricant
Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
40
Total80

Baseline characteristics

CharacteristicLubricantNo LubricantTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
40 Participants40 Participants80 Participants
Number of subjects with best corrected visual acuity of 20/40 or better in each eye40 participants40 participants80 participants
Region of Enrollment
United States
40 participants40 participants80 participants
Sex: Female, Male
Female
26 Participants27 Participants53 Participants
Sex: Female, Male
Male
14 Participants13 Participants27 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 400 / 40
serious
Total, serious adverse events
0 / 400 / 40

Outcome results

Primary

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.

Time frame: Day 1, End of Week 1

Population: Subjects that completed LASIK surgery.

ArmMeasureGroupValue (MEAN)Dispersion
LubricantEpithelial Healing After Laser Assisted in Situ Keratomileusis (LASIK) SurgeryDay 1 post LASIK surgery4.3 Clock HoursStandard Deviation 3.8
LubricantEpithelial Healing After Laser Assisted in Situ Keratomileusis (LASIK) SurgeryWeek 1 post LASIK surgery9.2 Clock HoursStandard Deviation 1.5
No LubricantEpithelial Healing After Laser Assisted in Situ Keratomileusis (LASIK) SurgeryDay 1 post LASIK surgery3.5 Clock HoursStandard Deviation 3
No LubricantEpithelial Healing After Laser Assisted in Situ Keratomileusis (LASIK) SurgeryWeek 1 post LASIK surgery9.0 Clock HoursStandard Deviation 1.8
Secondary

Post Operative Pain Level

Assess whether preoperative GenTeal Gel alleviates post operative pain in LASIK surgery patients compared to control (no preoperative lubricant) as measured by patient completion of the Universal Pain Assessment Tool (moderate), a ten point scale with 0 being no pain and 10 being the worst pain possible. Data on the level of pain only in the right eye will be collected.

Time frame: Day 1, End of Week 1

Population: Subjects that completed LASIK surgery.

ArmMeasureGroupValue (MEAN)Dispersion
LubricantPost Operative Pain LevelDay 1 post LASIK Surgery5.2 units on a scaleStandard Deviation 2.6
LubricantPost Operative Pain LevelEnd of Week 1 post LASIK surgery2.8 units on a scaleStandard Deviation 2.1
No LubricantPost Operative Pain LevelDay 1 post LASIK Surgery5.4 units on a scaleStandard Deviation 2.5
No LubricantPost Operative Pain LevelEnd of Week 1 post LASIK surgery3.1 units on a scaleStandard Deviation 2.6
Secondary

Tolerability and Alleviation of Post-operative Pain in LASIK Surgery

A comparison of subjective comfort level defined as tolerability and alleviation of post-operative pain experienced as a result of post-operative application of GenTeal drops. Subjective pain level was measured on a 10 point likert scale where 0 = no pain and 10 = worst pain possible. A lower score at Week 1 as compared to Day 1 was considered improved. A same score or higher at week 1 as compared to day 1 was considered no improvement.

Time frame: Week 1 post surgery

Population: Subjects randomized to either group and completed LASIK surgery.

ArmMeasureGroupValue (NUMBER)
LubricantTolerability and Alleviation of Post-operative Pain in LASIK SurgeryComfort level iimproved at Week 180 percentage of subjects
LubricantTolerability and Alleviation of Post-operative Pain in LASIK SurgeryComfort level not improved at week 120 percentage of subjects
No LubricantTolerability and Alleviation of Post-operative Pain in LASIK SurgeryComfort level iimproved at Week 187.5 percentage of subjects
No LubricantTolerability and Alleviation of Post-operative Pain in LASIK SurgeryComfort level not improved at week 112.5 percentage of subjects

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026