Trial Outcomes & Findings for Can Pregabalin Reduce the Frequency and Severity of Dry Eye Symptoms After Laser-assisted in Situ Keratomileusis? (NCT NCT02701764)

NCT ID: NCT02701764

Last Updated: 2019-11-14

Results Overview

DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye. Absolute score will be reported from DEQ5 questionnaire completed at 6 month visit.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 43 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-11-14

Participant Flow

Participant milestones

Measure	Pregabalin Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total. Pregabalin	Placebo Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total. Placebo
Overall Study STARTED	21	22
Overall Study COMPLETED	21	21
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Pregabalin Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total. Pregabalin	Placebo Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total. Placebo
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Can Pregabalin Reduce the Frequency and Severity of Dry Eye Symptoms After Laser-assisted in Situ Keratomileusis?

Baseline characteristics by cohort

Measure	Pregabalin n=21 Participants Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total. Pregabalin	Placebo n=22 Participants Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total. Placebo	Total n=43 Participants Total of all reporting groups
Age, Continuous	37.8 years STANDARD_DEVIATION 9.8 • n=5 Participants	33.0 years STANDARD_DEVIATION 0.6 • n=7 Participants	35.33 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	8 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	14 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: One participant in the placebo group did not complete 6 month visit

DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye. Absolute score will be reported from DEQ5 questionnaire completed at 6 month visit.

Outcome measures

Measure	Pregabalin n=21 Participants Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total. Pregabalin	Placebo n=21 Participants Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total. Placebo
Severity of Dry Eye Symptoms as Assessed by the Dry Eye Questionnaire - 5 (DEQ5)	6.6 score on a scale Standard Deviation 5.0	4.5 score on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: 3 months, 6 months

Population: One participant in the placebo group did not complete the 6 month visit.

OSDI total score ranges from 0-100 with a higher score indicating greater disability. Absolute scores will be reported from OSDI questionnaire completed at 3 and 6 month visit.

Outcome measures

Measure	Pregabalin n=21 Participants Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total. Pregabalin	Placebo n=22 Participants Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total. Placebo
Dry Eye Symptoms as Evaluated by the Ocular Surface Disease Index (OSDI) 3 months	11.9 score on a scale Standard Deviation 11.5	11.0 score on a scale Standard Deviation 16.6
Dry Eye Symptoms as Evaluated by the Ocular Surface Disease Index (OSDI) 6 months	12.6 score on a scale Standard Deviation 15.0	12.3 score on a scale Standard Deviation 16.8

SECONDARY outcome

Timeframe: 3 months, 6 months

Population: One participant in the placebo group did not complete the 6 month visit

Tear production will be measured via Schirmers score. Schirmer strips will be placed in the outer 1/3 of the lower conjunctivae. The Schirmer score will be evaluated as the length of wetting in mm in the Schirmer strips after 5 minutes. Absolute scores will be reported for the tear production evaluation at the 3 and 6 months visit.

Outcome measures

Measure	Pregabalin n=21 Participants Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total. Pregabalin	Placebo n=22 Participants Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total. Placebo
Tear Production Measured by Schirmers Score 3 months	12.40 mm wetting Standard Deviation 8.71	15.90 mm wetting Standard Deviation 9.32
Tear Production Measured by Schirmers Score 6 months	15.45 mm wetting Standard Deviation 8.17	15.05 mm wetting Standard Deviation 8.64

SECONDARY outcome

Timeframe: 3 months, 6 months

Population: One participant in the placebo group did not complete 6 month visit

Participant will have 5 μl of preservative free fluorescein placed on their eye. The participant will then be positioned in the head rest of the slit lamp instrument and will be instructed to blink three times naturally and then not blink. The integrity of the tear film will be measured and, using a stopwatch, the time from the last blink until one or more black (dry) spots appear in the precorneal tear film will be recorded as TBUT. The absolute scores for TBUT completed on the 3 and 6 month visit will be reported.

Outcome measures

Measure	Pregabalin n=21 Participants Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total. Pregabalin	Placebo n=22 Participants Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total. Placebo
Tear Evaporation Measured by Tear Break up Time (TBUT) 6 months	8.35 Seconds Standard Deviation 2.46	9.05 Seconds Standard Deviation 5.93
Tear Evaporation Measured by Tear Break up Time (TBUT) 3 months	7.10 Seconds Standard Deviation 3.87	9.54 Seconds Standard Deviation 5.58

SECONDARY outcome

Timeframe: 3 months, 6 months

Population: One participant in the placebo group did not complete the 6 month visit.

NPSI-E total score ranges from 0-100 with a higher score indicating increased eye pain. Absolute scores will be reported from NPSI-Eye questionnaire completed at 3 and 6 month visit.

Outcome measures

Measure	Pregabalin n=21 Participants Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total. Pregabalin	Placebo n=22 Participants Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total. Placebo
Eye Pain as Evaluated by the Neuropathic Pain Symptom Inventory - Eye (NPSI-E) 3 months	2.70 score on a scale Standard Deviation 4.55	1.86 score on a scale Standard Deviation 4.07
Eye Pain as Evaluated by the Neuropathic Pain Symptom Inventory - Eye (NPSI-E) 6 months	2.81 score on a scale Standard Deviation 4.07	3.14 score on a scale Standard Deviation 5.85

SECONDARY outcome

Timeframe: 3 months, 6 months

Population: One participant in the placebo group did not complete the 6 month visit.

sf-MPQ Sensory has a total score ranging from 0-33 with a higher score indicating increased pain. Absolute scores will be reported from sf-MPQ Sensory questionnaire completed at 3 and 6 month visit.

Outcome measures

Measure	Pregabalin n=21 Participants Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total. Pregabalin	Placebo n=22 Participants Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total. Placebo
Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Sensory 3 months	0.65 score on a scale Standard Deviation 1.23	0.36 score on a scale Standard Deviation 0.66
Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Sensory 6 months	0.48 score on a scale Standard Deviation 1.03	0.81 score on a scale Standard Deviation 2.42

SECONDARY outcome

Timeframe: 3 months, 6 months

Population: One participant in the placebo group did not complete the 6 month visit.

sf-MPQ Affective has a total score ranging from 0-12 with a higher score indicating increased pain. Absolute scores will be reported from sf-MPQ Affective questionnaire completed at 3 and 6 month visit.

Outcome measures

Measure	Pregabalin n=21 Participants Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total. Pregabalin	Placebo n=22 Participants Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total. Placebo
Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Affective 3 months	0.30 score on a scale Standard Deviation 0.66	0.18 score on a scale Standard Deviation 0.39
Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Affective 6 months	0.29 score on a scale Standard Deviation 0.46	0.43 score on a scale Standard Deviation 0.98

SECONDARY outcome

Timeframe: 3 months, 6 months

Population: One participant in the placebo group did not complete the 6 month visit.

NRS total score ranges from 0-10 over a one week recall period with the higher score indicating increased pain. Absolute scores will be reported from NRS questionnaire completed at 3 and 6 month visit.

Outcome measures

Measure	Pregabalin n=21 Participants Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total. Pregabalin	Placebo n=22 Participants Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total. Placebo
Eye Pain as Assessed by the Numeric Rating Scale (NRS) 3 months	0.85 score on a scale Standard Deviation 0.27	0.27 score on a scale Standard Deviation 0.55
Eye Pain as Assessed by the Numeric Rating Scale (NRS) 6 months	1.10 score on a scale Standard Deviation 1.48	0.38 score on a scale Standard Deviation 0.97

Adverse Events

Pregabalin

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pregabalin n=21 participants at risk Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total. Pregabalin	Placebo n=22 participants at risk Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total. Placebo
General disorders Tiredness	38.1% 8/21 • 6 months	9.1% 2/22 • 6 months
Nervous system disorders Dizziness	28.6% 6/21 • 6 months	4.5% 1/22 • 6 months
Nervous system disorders Headache	14.3% 3/21 • 6 months	13.6% 3/22 • 6 months
Gastrointestinal disorders Nausea	4.8% 1/21 • 6 months	9.1% 2/22 • 6 months
Gastrointestinal disorders Dry mouth	14.3% 3/21 • 6 months	0.00% 0/22 • 6 months
Gastrointestinal disorders Constipation	14.3% 3/21 • 6 months	4.5% 1/22 • 6 months
Gastrointestinal disorders Bloating	14.3% 3/21 • 6 months	18.2% 4/22 • 6 months
Psychiatric disorders High or elevated mood	19.0% 4/21 • 6 months	4.5% 1/22 • 6 months

Additional Information

Dr. Anat Galor

University of Miami

Phone: 305-450-6050

Email: agalor@med.miami.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place