Trial Outcomes & Findings for A Comparison of Pregabalin (Lyrica®) to Placebo in Pain Relief After Photorefractive Keratectomy (PRK) Surgery (NCT NCT01097577)
NCT ID: NCT01097577
Last Updated: 2020-10-28
Results Overview
Determine if clinical efficacy is achieved with pregabalin administered prior to PRK and continued for 5 days. This will be evaluated using the short-form McGill pain questionnaire (SF-MPQ). Primary efficacy is assessed on 100mm Visual Analog Scale (VAS); total range is 0 to 100. A score closer to zero indicates a better outcome of less pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
130 participants
Primary outcome timeframe
5 days
Results posted on
2020-10-28
Participant Flow
Participant milestones
| Measure |
Pregabalin
pregabalin: 1 capsule (75 mg) PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
|
Lactose Capsule
Placebo: 1 capsule PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
63
|
|
Overall Study
COMPLETED
|
67
|
62
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Pregabalin
pregabalin: 1 capsule (75 mg) PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
|
Lactose Capsule
Placebo: 1 capsule PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Comparison of Pregabalin (Lyrica®) to Placebo in Pain Relief After Photorefractive Keratectomy (PRK) Surgery
Baseline characteristics by cohort
| Measure |
Pregabalin
n=67 Participants
pregabalin: 1 capsule (75 mg) PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
|
Lactose Capsule
n=63 Participants
Placebo: 1 capsule PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.6 years
n=5 Participants
|
35.1 years
n=7 Participants
|
34.85 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
38 participants
n=5 Participants
|
45 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
12 participants
n=5 Participants
|
7 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
67 participants
n=5 Participants
|
63 participants
n=7 Participants
|
130 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 daysDetermine if clinical efficacy is achieved with pregabalin administered prior to PRK and continued for 5 days. This will be evaluated using the short-form McGill pain questionnaire (SF-MPQ). Primary efficacy is assessed on 100mm Visual Analog Scale (VAS); total range is 0 to 100. A score closer to zero indicates a better outcome of less pain.
Outcome measures
| Measure |
Pregabalin
n=67 Participants
pregabalin: 1 capsule (75 mg) PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
|
Lactose Capsule
n=63 Participants
Placebo: 1 capsule PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
|
|---|---|---|
|
Clinical Efficacy
Baseline
|
0.89 units on a scale
Standard Deviation 2.51
|
1.33 units on a scale
Standard Deviation 8.3
|
|
Clinical Efficacy
Surgery Day
|
7.56 units on a scale
Standard Deviation 10.95
|
10.34 units on a scale
Standard Deviation 16.55
|
|
Clinical Efficacy
Postop day 1 morning
|
6.32 units on a scale
Standard Deviation 9.14
|
10.22 units on a scale
Standard Deviation 15.27
|
|
Clinical Efficacy
Postop day 1 evening
|
21.32 units on a scale
Standard Deviation 21.95
|
27.09 units on a scale
Standard Deviation 25.03
|
|
Clinical Efficacy
Postop day 2 morning
|
23.49 units on a scale
Standard Deviation 21.31
|
29.27 units on a scale
Standard Deviation 25.1
|
|
Clinical Efficacy
Postop day 2 evening
|
26.14 units on a scale
Standard Deviation 22.79
|
25.78 units on a scale
Standard Deviation 26.66
|
|
Clinical Efficacy
Postop day 3 morning
|
8.48 units on a scale
Standard Deviation 12.84
|
8.76 units on a scale
Standard Deviation 15.66
|
|
Clinical Efficacy
Postop day 3 evening
|
3.48 units on a scale
Standard Deviation 6.74
|
6.02 units on a scale
Standard Deviation 11.18
|
|
Clinical Efficacy
Postop day 4 morning
|
1.9 units on a scale
Standard Deviation 4.56
|
2.65 units on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: 5 daysDetermine if clinical efficacy is achieved with pregabalin administered prior to PRK and continued for 5 days. This will be evaluated using the short-form McGill pain questionnaire (SF-MPQ). Secondary efficacy is assessed with present pain intensity (PPI) score. Scale is 0 (no pain) to 5 (excruciating pain)
Outcome measures
| Measure |
Pregabalin
n=67 Participants
pregabalin: 1 capsule (75 mg) PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
|
Lactose Capsule
n=63 Participants
Placebo: 1 capsule PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
|
|---|---|---|
|
PPI Score
Baseline
|
0.03 score on a scale
Standard Deviation 0.17
|
0.03 score on a scale
Standard Deviation 0.25
|
|
PPI Score
Surgery Day
|
0.69 score on a scale
Standard Deviation 0.76
|
0.84 score on a scale
Standard Deviation 0.79
|
|
PPI Score
Postop day 1 morning
|
0.67 score on a scale
Standard Deviation 0.73
|
0.89 score on a scale
Standard Deviation 0.88
|
|
PPI Score
Postop day 1 evening
|
1.37 score on a scale
Standard Deviation 0.89
|
1.62 score on a scale
Standard Deviation 1.24
|
|
PPI Score
Postop day 2 morning
|
1.43 score on a scale
Standard Deviation 0.89
|
1.62 score on a scale
Standard Deviation 0.99
|
|
PPI Score
Postop day 2 evening
|
1.46 score on a scale
Standard Deviation 0.94
|
1.48 score on a scale
Standard Deviation 1.05
|
|
PPI Score
Postop day 3 morning
|
0.67 score on a scale
Standard Deviation 0.77
|
0.68 score on a scale
Standard Deviation 0.93
|
|
PPI Score
Postop day 3 evening
|
0.3 score on a scale
Standard Deviation 0.58
|
0.48 score on a scale
Standard Deviation 0.78
|
|
PPI Score
Postop day 4 morning
|
0.18 score on a scale
Standard Deviation 0.46
|
0.22 score on a scale
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: 5 daysDetermine if clinical efficacy is achieved with pregabalin administered prior to PRK and continued for 5 days. This will be evaluated using the short-form McGill pain questionnaire (SF-MPQ). Secondary efficacy is assessed using the Total MPQ Score. Scale minimum is 0 (no pain) to maximum of 45 (severe pain). A higher score indicates a worse outcome.
Outcome measures
| Measure |
Pregabalin
n=67 Participants
pregabalin: 1 capsule (75 mg) PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
|
Lactose Capsule
n=63 Participants
Placebo: 1 capsule PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
|
|---|---|---|
|
Total MPQ Score
Baseline
|
0.15 score on a scale
Standard Deviation 0.47
|
0.16 score on a scale
Standard Deviation 0.85
|
|
Total MPQ Score
Surgery Day
|
1.85 score on a scale
Standard Deviation 2.28
|
2.18 score on a scale
Standard Deviation 3.01
|
|
Total MPQ Score
Postop day 1 morning
|
1.79 score on a scale
Standard Deviation 2.16
|
2.16 score on a scale
Standard Deviation 2.36
|
|
Total MPQ Score
Postop day 1 evening
|
4.6 score on a scale
Standard Deviation 5.07
|
5.37 score on a scale
Standard Deviation 6.67
|
|
Total MPQ Score
Postop day 2 morning
|
4.67 score on a scale
Standard Deviation 3.9
|
5.61 score on a scale
Standard Deviation 6.5
|
|
Total MPQ Score
Postop day 2 evening
|
4.87 score on a scale
Standard Deviation 4.1
|
5.68 score on a scale
Standard Deviation 7.54
|
|
Total MPQ Score
Postop day 3 morning
|
1.7 score on a scale
Standard Deviation 2.34
|
2.9 score on a scale
Standard Deviation 6.21
|
|
Total MPQ Score
Postop day 3 evening
|
0.97 score on a scale
Standard Deviation 2.02
|
1.16 score on a scale
Standard Deviation 1.72
|
|
Total MPQ Score
Postop day 4 morning
|
0.6 score on a scale
Standard Deviation 1.35
|
0.39 score on a scale
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: 5 daysDetermine if there was an improvement in the patient's functional health and well-being associated with pregabalin compared to standard of care as assessed by Brief Pain Inventory-short form (BPI-SF). Data was assessed on the day of surgery (Day 0) and at the expected peak of pain, postop Day 2 in the morning. Scale is minimum 0 (no pain) to maximum of 10 (pain as bad as you can imagine). A higher score indicates a worse outcome.
Outcome measures
| Measure |
Pregabalin
n=67 Participants
pregabalin: 1 capsule (75 mg) PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
|
Lactose Capsule
n=63 Participants
Placebo: 1 capsule PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
|
|---|---|---|
|
Quality of Life - BPI
Pain at its Worst, Day0
|
0.51 score on a scale
Standard Deviation 1.02
|
0.24 score on a scale
Standard Deviation 1.011
|
|
Quality of Life - BPI
Pain at its Worst, Day2
|
3.76 score on a scale
Standard Deviation 2.511
|
4.67 score on a scale
Standard Deviation 2.84
|
|
Quality of Life - BPI
Pain at its Least, Day 0
|
0.13 score on a scale
Standard Deviation 0.519
|
0.08 score on a scale
Standard Deviation 0.517
|
|
Quality of Life - BPI
Pain at its least, Day2
|
1.31 score on a scale
Standard Deviation 1.588
|
1.48 score on a scale
Standard Deviation 1.83
|
|
Quality of Life - BPI
Avg Pain, Day0
|
0.37 score on a scale
Standard Deviation 0.693
|
0.33 score on a scale
Standard Deviation 1.122
|
|
Quality of Life - BPI
Avg Pain, Day2
|
2.28 score on a scale
Standard Deviation 1.929
|
3.03 score on a scale
Standard Deviation 2.155
|
|
Quality of Life - BPI
Pain Interference, Day0
|
0.13 score on a scale
Standard Deviation 0.484
|
0.13 score on a scale
Standard Deviation 0.742
|
|
Quality of Life - BPI
Pain Interference, Day2
|
2.56 score on a scale
Standard Deviation 2.161
|
3.5 score on a scale
Standard Deviation 2.832
|
SECONDARY outcome
Timeframe: 5 daysDetermine if there was a reduction in the need for use of rescue pain medications, Percocet and tetracaine, in those subjects who received pregabalin. Total number of doses was collected. A higher number of doses required indicates a worse outcome.
Outcome measures
| Measure |
Pregabalin
n=67 Participants
pregabalin: 1 capsule (75 mg) PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
|
Lactose Capsule
n=63 Participants
Placebo: 1 capsule PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
|
|---|---|---|
|
Clinical Efficacy 2
Surgery Day
|
0.81 Rescue medication doses
Standard Deviation 1.234
|
0.94 Rescue medication doses
Standard Deviation 1.134
|
|
Clinical Efficacy 2
Postop Day 1
|
1.7 Rescue medication doses
Standard Deviation 1.842
|
2.44 Rescue medication doses
Standard Deviation 2.014
|
|
Clinical Efficacy 2
Postop Day 3
|
1.7 Rescue medication doses
Standard Deviation 1.633
|
2.56 Rescue medication doses
Standard Deviation 2.589
|
|
Clinical Efficacy 2
Postop Day 4
|
0.43 Rescue medication doses
Standard Deviation 0.802
|
0.62 Rescue medication doses
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: 5 days or moreDetermine if there was a reduction in healing time associated with pregabalin as seen with daily slit-lamp observation. Epithelial defect was measured at post-operative day 3, 5, 7, and 9 in each eye. A higher number of days required for healing indicates a worse outcome.
Outcome measures
| Measure |
Pregabalin
n=134 eyes
pregabalin: 1 capsule (75 mg) PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
|
Lactose Capsule
n=126 eyes
Placebo: 1 capsule PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
|
|---|---|---|
|
Epithelial Healing Time
Days to Heal OD (Right Eye)
|
3 Days
Standard Deviation 1.087
|
2.9 Days
Standard Deviation 0.856
|
|
Epithelial Healing Time
Days to Heal OS (Left Eye)
|
3.09 Days
Standard Deviation 1.164
|
2.9 Days
Standard Deviation 0.856
|
Adverse Events
Pregabalin
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Lactose Capsule
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pregabalin
n=67 participants at risk
pregabalin: 1 capsule (75 mg) PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
|
Lactose Capsule
n=62 participants at risk
Placebo: 1 capsule PO BID starting two hours prior to surgery and continuing 4 days postoperatively.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.5%
3/67 • Number of events 3 • 5 days
Adverse events were self-reported by the patients to the investigators at each follow-up evaluation. Each adverse event reported was monitored daily until resolution.
|
14.5%
9/62 • Number of events 11 • 5 days
Adverse events were self-reported by the patients to the investigators at each follow-up evaluation. Each adverse event reported was monitored daily until resolution.
|
|
Nervous system disorders
Somnolence
|
13.4%
9/67 • Number of events 9 • 5 days
Adverse events were self-reported by the patients to the investigators at each follow-up evaluation. Each adverse event reported was monitored daily until resolution.
|
0.00%
0/62 • 5 days
Adverse events were self-reported by the patients to the investigators at each follow-up evaluation. Each adverse event reported was monitored daily until resolution.
|
|
Nervous system disorders
Dizziness/Lightheadedness
|
14.9%
10/67 • Number of events 10 • 5 days
Adverse events were self-reported by the patients to the investigators at each follow-up evaluation. Each adverse event reported was monitored daily until resolution.
|
3.2%
2/62 • Number of events 2 • 5 days
Adverse events were self-reported by the patients to the investigators at each follow-up evaluation. Each adverse event reported was monitored daily until resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea/congestion
|
10.4%
7/67 • Number of events 7 • 5 days
Adverse events were self-reported by the patients to the investigators at each follow-up evaluation. Each adverse event reported was monitored daily until resolution.
|
3.2%
2/62 • Number of events 2 • 5 days
Adverse events were self-reported by the patients to the investigators at each follow-up evaluation. Each adverse event reported was monitored daily until resolution.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place