Trial Outcomes & Findings for Efficacy, Tolerability, and Comfort of 0.3% Hypromellose Eyedrops in Patients Undergoing LASIK Surgery (NCT NCT00909324)
NCT ID: NCT00909324
Last Updated: 2020-08-17
Results Overview
Patients rated their ocular comfort on a scale of 0 to 10 on the following parameters: Burning sensation, foreign body sensation, itching, watering of eyes, dryness of eyes, and photophobia. A higher score indicated greater discomfort. A negative change score indicated improvement.
COMPLETED
PHASE4
170 participants
Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery
2020-08-17
Participant Flow
Participant milestones
| Measure |
Pre-LASIK 0.3% Hypromellose
Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
|
Post-LASIK 0.3% Hypromellose
Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
90
|
|
Overall Study
COMPLETED
|
72
|
90
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy, Tolerability, and Comfort of 0.3% Hypromellose Eyedrops in Patients Undergoing LASIK Surgery
Baseline characteristics by cohort
| Measure |
Pre-LASIK 0.3% Hypromellose
n=72 Participants
Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
|
Post-LASIK 0.3% Hypromellose
n=90 Participants
Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.24 Years
STANDARD_DEVIATION 4.81 • n=99 Participants
|
25.99 Years
STANDARD_DEVIATION 5.06 • n=107 Participants
|
26.10 Years
STANDARD_DEVIATION 4.93 • n=206 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
116 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgeryPopulation: Intent-to-Treat population: All patients in the study who received study treatment.
Patients rated their ocular comfort on a scale of 0 to 10 on the following parameters: Burning sensation, foreign body sensation, itching, watering of eyes, dryness of eyes, and photophobia. A higher score indicated greater discomfort. A negative change score indicated improvement.
Outcome measures
| Measure |
Pre-LASIK 0.3% Hypromellose
n=72 Participants
Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
|
Post-LASIK 0.3% Hypromellose
n=90 Participants
Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
|
|---|---|---|
|
Ocular Comfort Level From Baseline to End of Study
Foreign body sensation: Day 30
|
0.05 Units on a scale
Standard Deviation 0.29
|
0.09 Units on a scale
Standard Deviation 0.33
|
|
Ocular Comfort Level From Baseline to End of Study
Watering of eyes: Day 7
|
0.22 Units on a scale
Standard Deviation 0.49
|
0.25 Units on a scale
Standard Deviation 0.49
|
|
Ocular Comfort Level From Baseline to End of Study
Burning in eyes: Post-LASIK Day 1
|
0.68 Units on a scale
Standard Deviation 1.18
|
0.84 Units on a scale
Standard Deviation 1.16
|
|
Ocular Comfort Level From Baseline to End of Study
Burning in eyes: Day 7
|
0.24 Units on a scale
Standard Deviation 0.52
|
0.31 Units on a scale
Standard Deviation 0.54
|
|
Ocular Comfort Level From Baseline to End of Study
Burning in eyes: Day 30
|
0.08 Units on a scale
Standard Deviation 0.33
|
0.07 Units on a scale
Standard Deviation 0.26
|
|
Ocular Comfort Level From Baseline to End of Study
Foreign body sensation: Post-LASIK Day 1
|
0.94 Units on a scale
Standard Deviation 1.47
|
1.09 Units on a scale
Standard Deviation 1.41
|
|
Ocular Comfort Level From Baseline to End of Study
Foreign body sensation: Day 7
|
0.26 Units on a scale
Standard Deviation 0.56
|
0.27 Units on a scale
Standard Deviation 0.55
|
|
Ocular Comfort Level From Baseline to End of Study
Itching: Post-LASIK Day 1
|
0.35 Units on a scale
Standard Deviation 0.77
|
0.71 Units on a scale
Standard Deviation 1.21
|
|
Ocular Comfort Level From Baseline to End of Study
Itching: Day 7
|
0.16 Units on a scale
Standard Deviation 0.48
|
0.32 Units on a scale
Standard Deviation 0.68
|
|
Ocular Comfort Level From Baseline to End of Study
Itching: Day 30
|
0.05 Units on a scale
Standard Deviation 0.22
|
0.13 Units on a scale
Standard Deviation 0.42
|
|
Ocular Comfort Level From Baseline to End of Study
Watering of eyes: Post-LASIK Day 1
|
0.71 Units on a scale
Standard Deviation 0.94
|
0.71 Units on a scale
Standard Deviation 0.96
|
|
Ocular Comfort Level From Baseline to End of Study
Watering of eyes: Day 30
|
0.10 Units on a scale
Standard Deviation 0.30
|
0.09 Units on a scale
Standard Deviation 0.29
|
|
Ocular Comfort Level From Baseline to End of Study
Dryness of eyes: Post-LASIK Day 1
|
0.82 Units on a scale
Standard Deviation 1.18
|
1.28 Units on a scale
Standard Deviation 1.71
|
|
Ocular Comfort Level From Baseline to End of Study
Dryness of eyes: Day 7
|
0.41 Units on a scale
Standard Deviation 0.72
|
0.72 Units on a scale
Standard Deviation 0.98
|
|
Ocular Comfort Level From Baseline to End of Study
Dryness of eyes: Day 30
|
0.25 Units on a scale
Standard Deviation 0.60
|
0.49 Units on a scale
Standard Deviation 0.84
|
|
Ocular Comfort Level From Baseline to End of Study
Photophobia: Post-LASIK Day 1
|
0.22 Units on a scale
Standard Deviation 0.54
|
0.41 Units on a scale
Standard Deviation 0.90
|
|
Ocular Comfort Level From Baseline to End of Study
Photophobia: Day 7
|
0.09 Units on a scale
Standard Deviation 0.33
|
0.09 Units on a scale
Standard Deviation 0.37
|
|
Ocular Comfort Level From Baseline to End of Study
Photophobia: Day 30
|
0.08 Units on a scale
Standard Deviation 0.33
|
0.07 Units on a scale
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgeryPopulation: Intent-to-Treat population: All patients in the study who received study treatment.
The time required for dry spots to appear on the corneal surface after blinking. Sodium fluorescein dye is added to the eye and the tear film is observed under a slit lamp while the patient avoids blinking until tiny dry spots develop. The longer it takes, the more stable the tear film. A short tear breakup time is a sign of a poor tear film. Generally, \>10 seconds is thought to be normal, 5 to 10 seconds marginal, and \<5 seconds low (with high likelihood of dry eye symptoms), ie, a shorter time indicates greater eye dryness. A positive change score indicates improvement.
Outcome measures
| Measure |
Pre-LASIK 0.3% Hypromellose
n=72 Participants
Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
|
Post-LASIK 0.3% Hypromellose
n=90 Participants
Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
|
|---|---|---|
|
Tear Breakup Time From Baseline to End of Study
Post-LASIK Day 1
|
14.60 Seconds
Standard Deviation 6.06
|
12.47 Seconds
Standard Deviation 6.20
|
|
Tear Breakup Time From Baseline to End of Study
Day 7
|
13.47 Seconds
Standard Deviation 6.22
|
10.84 Seconds
Standard Deviation 3.58
|
|
Tear Breakup Time From Baseline to End of Study
Day 30
|
13.63 Seconds
Standard Deviation 5.36
|
12.70 Seconds
Standard Deviation 5.38
|
SECONDARY outcome
Timeframe: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgeryPopulation: Intent-to-Treat population: All patients in the study who received study treatment.
Schirmer's test determines tear production, and whether the eye produces enough tears to keep it moist. A small strip of filter paper is inserted inside the lower eyelid of each eye and the eyes are closed for 5 minutes. The paper is then removed and the length of paper that is moist is measured. A young person normally moistens 15 mm of the paper. The shorter the length of moist paper, the dryer the eyes. A positive change score indicates improvement.
Outcome measures
| Measure |
Pre-LASIK 0.3% Hypromellose
n=72 Participants
Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
|
Post-LASIK 0.3% Hypromellose
n=90 Participants
Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
|
|---|---|---|
|
Results of Schirmer's Test From Baseline to End of Study
Left eye: Post-LASIK Day 1
|
19.64 mm
Standard Deviation 8.50
|
17.21 mm
Standard Deviation 7.10
|
|
Results of Schirmer's Test From Baseline to End of Study
Left eye: Day 7
|
17.68 mm
Standard Deviation 9.93
|
17.93 mm
Standard Deviation 5.43
|
|
Results of Schirmer's Test From Baseline to End of Study
Left eye: Day 30
|
21.70 mm
Standard Deviation 13.01
|
18.77 mm
Standard Deviation 7.11
|
|
Results of Schirmer's Test From Baseline to End of Study
Right eye: Post-LASIK Day 1
|
22.65 mm
Standard Deviation 7.10
|
13.70 mm
Standard Deviation 2.91
|
|
Results of Schirmer's Test From Baseline to End of Study
Right eye: Day 7
|
22.78 mm
Standard Deviation 0.49
|
15.25 mm
Standard Deviation 0.49
|
|
Results of Schirmer's Test From Baseline to End of Study
Right eye: Day 30
|
22.89 mm
Standard Deviation 2.47
|
18.35 mm
Standard Deviation 3.83
|
Adverse Events
Pre-LASIK 0.3% Hypromellose
Post-LASIK 0.3% Hypromellose
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 The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER