Trial Outcomes & Findings for Study of Cyclosporine in Post-LASIK Patients (NCT NCT00991458)
NCT ID: NCT00991458
Last Updated: 2013-07-11
Results Overview
Time to cure is defined as the number of days after laser in situ keratomileusis (LASIK) surgery that the patient has corneal sensitivity (the capability of the cornea to respond to stimulation) ≥ 50 millimeters in all 9 regions of both eyes after LASIK surgery. A patient is considered cured at the first of 2 consecutive visits meeting these criteria. The Inter-Quartile Range presented is actually the 25th Quantile and the 75th Quantile obtained from the Kaplan-Meier Model.
COMPLETED
PHASE2
621 participants
6 Months
2013-07-11
Participant Flow
Participant milestones
| Measure |
Cyclosporine 0.010% Eye Drops
Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
Cyclosporine 0.005% Eye Drops
Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
Placebo (Vehicle for Cyclosporine)
Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
|---|---|---|---|
|
Overall Study
STARTED
|
207
|
209
|
205
|
|
Overall Study
COMPLETED
|
187
|
181
|
180
|
|
Overall Study
NOT COMPLETED
|
20
|
28
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Cyclosporine in Post-LASIK Patients
Baseline characteristics by cohort
| Measure |
Cyclosporine 0.010% Eye Drops
n=207 Participants
Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
Cyclosporine 0.005% Eye Drops
n=209 Participants
Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
Placebo (Vehicle for Cyclosporine)
n=205 Participants
Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
Total
n=621 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<30 years
|
68 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
214 Participants
n=4 Participants
|
|
Age, Customized
30 to 40 years
|
110 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
299 Participants
n=4 Participants
|
|
Age, Customized
>40 years
|
29 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
338 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
283 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: Modified Intent to Treat: all randomized and treated patients with both eyes having Post-LASIK surgery and corneal sensitivity measurements of \< 25 mm in the 3 central regions at Post-Surgery Week 1.
Time to cure is defined as the number of days after laser in situ keratomileusis (LASIK) surgery that the patient has corneal sensitivity (the capability of the cornea to respond to stimulation) ≥ 50 millimeters in all 9 regions of both eyes after LASIK surgery. A patient is considered cured at the first of 2 consecutive visits meeting these criteria. The Inter-Quartile Range presented is actually the 25th Quantile and the 75th Quantile obtained from the Kaplan-Meier Model.
Outcome measures
| Measure |
Cyclosporine 0.010% Eye Drops
n=150 Participants
Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
Cyclosporine 0.005% Eye Drops
n=142 Participants
Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
Placebo (Vehicle for Cyclosporine)
n=139 Participants
Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
|---|---|---|---|
|
Time to Cure
|
189.0 Days
Interval 181.0 to
The upper limit was not reached at 6 months.
|
194.0 Days
Interval 181.0 to 196.0
|
189.0 Days
Interval 180.0 to
The upper limit was not reached at 6 months.
|
SECONDARY outcome
Timeframe: Months 3 to 6Population: Intent to Treat population: all randomized patients for whom data are available for this outcome measure.
The time to the worst outcome post-LASIK surgery in tear film stability is assessed using the Ocular Scatter Index (OSI). The OSI is calculated by an instrument which takes images of the eye over time. OSI values ≥3.0 indicate lower tear film quality resulting in a loss of visual acuity. The worst outcome post-LASIK surgery is defined as the shortest time to OSI ≥3 across both eyes and post-LASIK surgery months 3 to 6.
Outcome measures
| Measure |
Cyclosporine 0.010% Eye Drops
n=177 Participants
Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
Cyclosporine 0.005% Eye Drops
n=173 Participants
Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
Placebo (Vehicle for Cyclosporine)
n=174 Participants
Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
|---|---|---|---|
|
Time to Worst Outcome Post-LASIK Surgery in Tear Film Assessment
|
11.2 Seconds
Standard Deviation 4.24
|
12.0 Seconds
Standard Deviation 4.51
|
11.5 Seconds
Standard Deviation 4.39
|
SECONDARY outcome
Timeframe: Month 3, Month 4, Month 5, Month 6Population: Intent to treat: all randomized patients.
Cumulative Poor Vision is determined binocularly per patient (using both eyes at the same time) from the Poor Vision question on the Ocular Surface Disease Index (OSDI) questionnaire. Severity of poor vision is graded on a 5-point scale (0 = none of the time, 1 = some of the time, 2 = half of the time, 3 = most of the time, 4 = all of the time). Cumulative poor vision is defined as at least one poor vision score ≥ 1 beginning at Month 3 post-LASIK.
Outcome measures
| Measure |
Cyclosporine 0.010% Eye Drops
n=207 Participants
Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
Cyclosporine 0.005% Eye Drops
n=209 Participants
Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
Placebo (Vehicle for Cyclosporine)
n=205 Participants
Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
|---|---|---|---|
|
Percentage of Patients With Cumulative Poor Vision
Month 3
|
15.0 Percentage of Patients
|
18.7 Percentage of Patients
|
19.0 Percentage of Patients
|
|
Percentage of Patients With Cumulative Poor Vision
Month 4
|
17.9 Percentage of Patients
|
22.5 Percentage of Patients
|
23.9 Percentage of Patients
|
|
Percentage of Patients With Cumulative Poor Vision
Month 5
|
21.7 Percentage of Patients
|
26.3 Percentage of Patients
|
24.9 Percentage of Patients
|
|
Percentage of Patients With Cumulative Poor Vision
Month 6
|
23.7 Percentage of Patients
|
26.8 Percentage of Patients
|
26.3 Percentage of Patients
|
SECONDARY outcome
Timeframe: Months 3 to 6Population: Intent to Treat population: all randomized patients for whom data are available for this outcome measure.
Reading speed is determined using the MNREAD™ Reading Card. The MNREAD™ reading card is designed to simulate a normal every day reading scenario using binocular vision (both eyes at the same time). The MNREAD™ Reading speed is calculated as (60) X \[Number of words on card - (reading errors)\]/ (number of seconds until the card is read). The worst outcome is defined as the smallest number of words per minute across post-LASIK surgery months 3 to 6.
Outcome measures
| Measure |
Cyclosporine 0.010% Eye Drops
n=206 Participants
Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
Cyclosporine 0.005% Eye Drops
n=209 Participants
Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
Placebo (Vehicle for Cyclosporine)
n=205 Participants
Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
|---|---|---|---|
|
Worst Outcome Post-LASIK Surgery in Reading Speed Assessment
|
173.0 Words Per Minute (WPM)
Standard Deviation 40.17
|
173.7 Words Per Minute (WPM)
Standard Deviation 42.18
|
167.4 Words Per Minute (WPM)
Standard Deviation 45.21
|
Adverse Events
Cyclosporine 0.010% Eye Drops
Cyclosporine 0.005% Eye Drops
Placebo (Vehicle for Cyclosporine)
Serious adverse events
| Measure |
Cyclosporine 0.010% Eye Drops
n=207 participants at risk
Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
Cyclosporine 0.005% Eye Drops
n=209 participants at risk
Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
Placebo (Vehicle for Cyclosporine)
n=205 participants at risk
Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.48%
1/207
|
0.00%
0/209
|
0.00%
0/205
|
|
Reproductive system and breast disorders
Haemorrhagic Ovarian Cyst
|
0.87%
1/115
|
0.00%
0/118
|
0.00%
0/105
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.00%
0/115
|
0.00%
0/118
|
0.95%
1/105
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/115
|
0.00%
0/118
|
0.95%
1/105
|
|
Eye disorders
Refraction Disorder
|
0.00%
0/207
|
0.00%
0/209
|
0.49%
1/205
|
Other adverse events
| Measure |
Cyclosporine 0.010% Eye Drops
n=207 participants at risk
Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
Cyclosporine 0.005% Eye Drops
n=209 participants at risk
Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
Placebo (Vehicle for Cyclosporine)
n=205 participants at risk
Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
|
|---|---|---|---|
|
Eye disorders
Dry Eye
|
25.1%
52/207
|
23.0%
48/209
|
22.9%
47/205
|
|
Eye disorders
Punctate Keratitis
|
6.3%
13/207
|
5.3%
11/209
|
4.9%
10/205
|
|
Eye disorders
Vision Blurred
|
6.3%
13/207
|
3.3%
7/209
|
4.4%
9/205
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER