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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-26

Study Completion Date

2018-12-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pregabalin

Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total.

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

Placebo

Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Pregabalin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes