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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Dry Eye

In brief

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

Key facts

Study ID

NCT02701764

Run by

University of Miami

People needed

43

Starts

2016-07-26

Expected to finish

2018-12-01

Last updated by the study team

2019-11-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Anat Galor — Miami, Florida, United States

Full record on ClinicalTrials.gov

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