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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02701764

Enrollment

Registered

2016-03-08

Start date

2016-07-26

Completion date

2018-12-01

Last updated

2019-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

Keywords

laser-assisted in situ keratomileusis, dry eye symptoms, LASIK, prevention

Brief summary

Can Lyrica (Pregabalin) help prevent severe Dry Eye post LASIK surgery?

Detailed description

Dry eye symptoms can occur after LASIK surgery. They generally get better with time but in some patients, they can persist. The investigators believe that in some individuals, dry eye symptoms after LASIK persist because the nerves in the cornea become hypersensitive. The investigators wish to study if a medication, called pregabalin, can protect corneal nerves at the time of LASIK surgery and decrease the frequency and severity of dry eye symptoms 6 months after surgery. This medication has been used in a similar way to reduce the frequency of uncomfortable sensations after other surgeries (knee, abdomen) but has never been studied in LASIK surgery.

Interventions

DRUGPregabalin

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* 18 and 65 years of age * undergoing LASIK (unilateral or bilateral procedure). * Females of child-bearing age will need a negative urine or serum pregnancy test at the screening visit. * ocular and systemic medication regimen has been stable for 3 months

Exclusion criteria

* Pregnant or lactating, participating in another study with an investigational drug within one month prior to screening * Using gabapentin, pregabalin, anti-convulsants, duloxetine, venlafaxine (SNRI), or tri-cyclic antidepressants * have a history of allergic, anaphylactic reaction, or severe systemic response to pregabalin or gabapentin * use corticosteroids chronically or during the month prior to surgery, or have a history of corneal disease (HSV or varicella zoster keratitis, prior corneal incisions (cataract surgery, radial keratotomy, LASIK), prior corneal ulcer). * patients with systemic co-morbidities that may confound DE such as HIV, sarcoidosis, graft-versus host disease or a collagen vascular disease. * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Prisoners

Design outcomes

Primary

Measure	Time frame	Description
Severity of Dry Eye Symptoms as Assessed by the Dry Eye Questionnaire - 5 (DEQ5)	6 months	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.

Secondary

Measure	Time frame	Description
Tear Production Measured by Schirmers Score	3 months, 6 months	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.
Tear Evaporation Measured by Tear Break up Time (TBUT)	3 months, 6 months	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.
Eye Pain as Evaluated by the Neuropathic Pain Symptom Inventory - Eye (NPSI-E)	3 months, 6 months	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.
Dry Eye Symptoms as Evaluated by the Ocular Surface Disease Index (OSDI)	3 months, 6 months	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.
Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Affective	3 months, 6 months	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.
Eye Pain as Assessed by the Numeric Rating Scale (NRS)	3 months, 6 months	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.
Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Sensory	3 months, 6 months	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Pregabalin Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total. Pregabalin	21
Placebo Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total. Placebo	22
Total	43

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	0	1

Baseline characteristics

Characteristic	Placebo	Total	Pregabalin
Age, Continuous	33.0 years STANDARD_DEVIATION 0.6	35.33 years STANDARD_DEVIATION 9.9	37.8 years STANDARD_DEVIATION 9.8
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants	22 Participants	11 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants	21 Participants	10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	1 Participants	2 Participants	1 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants	5 Participants	2 Participants
Race (NIH/OMB) White	18 Participants	36 Participants	18 Participants
Sex: Female, Male Female	8 Participants	22 Participants	14 Participants
Sex: Female, Male Male	14 Participants	21 Participants	7 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 21	0 / 22
other Total, other adverse events	13 / 21	10 / 22
serious Total, serious adverse events	0 / 21	0 / 22

Outcome results

Primary

Severity of Dry Eye Symptoms as Assessed by the Dry Eye Questionnaire - 5 (DEQ5)

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.

Time frame: 6 months

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

Arm	Measure	Value (MEAN)	Dispersion
Pregabalin	Severity of Dry Eye Symptoms as Assessed by the Dry Eye Questionnaire - 5 (DEQ5)	6.6 score on a scale	Standard Deviation 5
Placebo	Severity of Dry Eye Symptoms as Assessed by the Dry Eye Questionnaire - 5 (DEQ5)	4.5 score on a scale	Standard Deviation 4.2

Secondary

Dry Eye Symptoms as Evaluated by the Ocular Surface Disease Index (OSDI)

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.