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

Phase 2

Completed

Conditions: Dry Eye

Interventions: Drug: Placebo
Drug: Pregabalin

Registration Number: NCT02701764

Lead Sponsor: University of Miami

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 43

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total.
Pregabalin	Pregabalin	Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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 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.
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.