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

NCT02701764 | Completed Phase 2 Results

• 1 other identifier: 20160095
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye

Keywords

laser-assisted in situ keratomileusis; dry eye symptoms; LASIK; prevention

Outcome Measures

Primary Outcomes (1)

• Severity of Dry Eye Symptoms as Assessed by the Dry Eye Questionnaire - 5 (DEQ5)

  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.

  6 months

Secondary Outcomes (7)

• Dry Eye Symptoms as Evaluated by the Ocular Surface Disease Index (OSDI)

  3 months, 6 months

• Tear Production Measured by Schirmers Score

  3 months, 6 months

• Tear Evaporation Measured by Tear Break up Time (TBUT)

  3 months, 6 months

• Eye Pain as Evaluated by the Neuropathic Pain Symptom Inventory - Eye (NPSI-E)

  3 months, 6 months

• Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Sensory

  3 months, 6 months

Study Arms (2)

Pregabalin

EXPERIMENTAL

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

Drug: Pregabalin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Pregabalin DRUG

Pregabalin

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Anat Galor

Miami, Florida, 33133, United States

Location

Related Publications (2)

• Levitt AE, Galor A, Weiss JS, Felix ER, Martin ER, Patin DJ, Sarantopoulos KD, Levitt RC. Chronic dry eye symptoms after LASIK: parallels and lessons to be learned from other persistent post-operative pain disorders. Mol Pain. 2015 Apr 21;11:21. doi: 10.1186/s12990-015-0020-7.

  PMID: 25896684 BACKGROUND

• Levitt AE, Galor A, Small L, Feuer W, Felix ER. Pain sensitivity and autonomic nervous system parameters as predictors of dry eye symptoms after LASIK. Ocul Surf. 2021 Jan;19:275-281. doi: 10.1016/j.jtos.2020.10.004. Epub 2020 Oct 21.

  PMID: 33096271 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Anat Galor
• Organization: University of Miami

agalor@med.miami.edu

305-450-6050

Study Officials

• Anat Galor, MD, MSPH

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Ophthalmology

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: March 8, 2016
• Study Start: July 26, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 14, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)