Trial Outcomes & Findings for GenTeal in Perioperative Treatment of Laser Assisted in Situ Keratomileusis LASIK Patients (NCT NCT00598689)
NCT ID: NCT00598689
Last Updated: 2016-03-07
Results Overview
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.
COMPLETED
PHASE4
80 participants
Day 1, End of Week 1
2016-03-07
Participant Flow
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.
Subjects were stratified based on smoking status.
Participant milestones
| Measure |
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
|
No Lubricant
Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GenTeal in Perioperative Treatment of Laser Assisted in Situ Keratomileusis LASIK Patients
Baseline characteristics by cohort
| Measure |
Lubricant
n=40 Participants
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
|
No Lubricant
n=40 Participants
Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=99 Participants
|
40 participants
n=107 Participants
|
80 participants
n=206 Participants
|
|
Number of subjects with best corrected visual acuity of 20/40 or better in each eye
|
40 participants
n=99 Participants
|
40 participants
n=107 Participants
|
80 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1, End of Week 1Population: Subjects that completed 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.
Outcome measures
| Measure |
Lubricant
n=40 Participants
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
|
No Lubricant
n=40 Participants
Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
|
|---|---|---|
|
Epithelial Healing After Laser Assisted in Situ Keratomileusis (LASIK) Surgery
Day 1 post LASIK surgery
|
4.3 Clock Hours
Standard Deviation 3.8
|
3.5 Clock Hours
Standard Deviation 3.0
|
|
Epithelial Healing After Laser Assisted in Situ Keratomileusis (LASIK) Surgery
Week 1 post LASIK surgery
|
9.2 Clock Hours
Standard Deviation 1.5
|
9.0 Clock Hours
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Day 1, End of Week 1Population: Subjects that completed LASIK surgery.
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.
Outcome measures
| Measure |
Lubricant
n=40 Participants
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
|
No Lubricant
n=40 Participants
Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
|
|---|---|---|
|
Post Operative Pain Level
Day 1 post LASIK Surgery
|
5.2 units on a scale
Standard Deviation 2.6
|
5.4 units on a scale
Standard Deviation 2.5
|
|
Post Operative Pain Level
End of Week 1 post LASIK surgery
|
2.8 units on a scale
Standard Deviation 2.1
|
3.1 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Week 1 post surgeryPopulation: Subjects randomized to either group and completed 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.
Outcome measures
| Measure |
Lubricant
n=40 Participants
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
|
No Lubricant
n=40 Participants
Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
|
|---|---|---|
|
Tolerability and Alleviation of Post-operative Pain in LASIK Surgery
Comfort level iimproved at Week 1
|
80 percentage of subjects
|
87.5 percentage of subjects
|
|
Tolerability and Alleviation of Post-operative Pain in LASIK Surgery
Comfort level not improved at week 1
|
20 percentage of subjects
|
12.5 percentage of subjects
|
Adverse Events
Lubricant
No Lubricant
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place