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

University of Miami

Status and phase: Completed; Phase 3; Phase 2

Conditions: Dry Eye

Treatments: Drug: Pregabalin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02701764

20160095

Details and patient eligibility

About

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

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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43 participants in 2 patient groups, including a placebo group

Pregabalin

Experimental group

Description:

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

Treatment:

Drug: Pregabalin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo