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

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Miami
• Treatments: Pregabalin

Criteria

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