Corneal Epithelium DefectPhase 4NCT00598689
GenTeal in Perioperative Treatment of Laser Assisted in Situ Keratomileusis LASIK Patients
A Phase 4 study testing 0.3% hypromellose in people with Corneal Epithelium Defect, run by Augusta University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Epithelium Defect
- What is being tested?
- 0.3% hypromellose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Oct 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy, Tolerability and Comfort of GenTeal and GenTeal Gel, (0.3% Hypromellose) in the Pre- and Post- Operative Treatment of Patients Undergoing LASIK Surgery
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.
Read the 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.
- Conditions
- Corneal Epithelium Defect
- Being tested
- 0.3% hypromellose
- Keywords
- LASIK, Ocular Lubricants, Corneal Epithelium, Wound Healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.3% hypromelloseDrug
Also called Genteal Gel
0.3% hypromellose four times a day for 5 days prior to LASIK surgery
| Study group | Role | What they receive |
|---|---|---|
| Lubricant | Experimental | Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1, End of Week 1
Secondary outcomes (2)
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.
Measured: Day 1, End of Week 1
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.
Measured: Week 1 post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corneal Epithelium DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, David Bogorad, Augusta University
- Investigators
- David D Bogorad, M.D, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598689
- Sponsor's protocol ID
- 07-09-052
- Status last verified
- Feb 2016
- First submitted
- 10 Jan 2008
- Last updated
- 7 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 12160811
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Tolerability and Comfort of GenTeal and GenTeal Gel, (0.3% Hypromellose) in the Pre- and Post- Operative Treatment of Patients Undergoing LASIK Surgery
- ClinicalTrials.gov ID
- NCT00598689
- Acronym / sponsor ID
- 07-09-052
- Conditions
- Corneal Epithelium Defect
- Keywords
- LASIK, Ocular Lubricants, Corneal Epithelium, Wound Healing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Oct 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 22 Jan 2008 (estimated)
- Results
- Posted 7 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lubricant | Experimental | Drug: 0.3% hypromellosePatients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery. |
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.3% hypromelloseAlso: Genteal Gel0.3% hypromellose four times a day for 5 days prior to LASIK surgery | Drug | Lubricant |
Primary outcome
Epithelial Healing After Laser Assisted in Situ Keratomileusis (LASIK) Surgery
Time frame: Day 1, End of Week 1
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.
2 secondary outcomes
Post Operative Pain Level
Time frame: Day 1, End of Week 1
Tolerability and Alleviation of Post-operative Pain in LASIK Surgery
Time frame: Week 1 post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12160811Samuel 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.
Related trials for Corneal Epithelium Defect
Not yet recruitingPhase 4
Evaluation of Dexpanthenol and Hyaluronic Acid Eye Drops on Corneal Epithelialization After Trans Epithelial PRK
Corneal Epithelial Wound Healing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David D Bogorad, M.D principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.3% hypromellose in people with Corneal Epithelium Defect, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epithelial Healing After Laser Assisted in Situ Keratomileusis (LASIK) Surgery (time frame: Day 1, End of Week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00598689, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2016.