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

November 12, 2019 updated by: Anat Galor, University of Miami
Can Lyrica (Pregabalin) help prevent severe Dry Eye post LASIK surgery?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33133
        • Anat Galor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pregabalin
Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total.
Drug: Pregabalin
Placebo Comparator: Placebo
Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of Dry Eye Symptoms as Assessed by the Dry Eye Questionnaire - 5 (DEQ5)
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dry Eye Symptoms as Evaluated by the Ocular Surface Disease Index (OSDI)
Time Frame: 3 months, 6 months
OSDI total score ranges from 0-100 with a higher score indicating greater disability. Absolute scores will be reported from OSDI questionnaire completed at 3 and 6 month visit.
3 months, 6 months
Tear Production Measured by Schirmers Score
Time Frame: 3 months, 6 months
Tear production will be measured via Schirmers score. Schirmer strips will be placed in the outer 1/3 of the lower conjunctivae. The Schirmer score will be evaluated as the length of wetting in mm in the Schirmer strips after 5 minutes. Absolute scores will be reported for the tear production evaluation at the 3 and 6 months visit.
3 months, 6 months
Tear Evaporation Measured by Tear Break up Time (TBUT)
Time Frame: 3 months, 6 months
Participant will have 5 μl of preservative free fluorescein placed on their eye. The participant will then be positioned in the head rest of the slit lamp instrument and will be instructed to blink three times naturally and then not blink. The integrity of the tear film will be measured and, using a stopwatch, the time from the last blink until one or more black (dry) spots appear in the precorneal tear film will be recorded as TBUT. The absolute scores for TBUT completed on the 3 and 6 month visit will be reported.
3 months, 6 months
Eye Pain as Evaluated by the Neuropathic Pain Symptom Inventory - Eye (NPSI-E)
Time Frame: 3 months, 6 months
NPSI-E total score ranges from 0-100 with a higher score indicating increased eye pain. Absolute scores will be reported from NPSI-Eye questionnaire completed at 3 and 6 month visit.
3 months, 6 months
Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Sensory
Time Frame: 3 months, 6 months
sf-MPQ Sensory has a total score ranging from 0-33 with a higher score indicating increased pain. Absolute scores will be reported from sf-MPQ Sensory questionnaire completed at 3 and 6 month visit.
3 months, 6 months
Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Affective
Time Frame: 3 months, 6 months
sf-MPQ Affective has a total score ranging from 0-12 with a higher score indicating increased pain. Absolute scores will be reported from sf-MPQ Affective questionnaire completed at 3 and 6 month visit.
3 months, 6 months
Eye Pain as Assessed by the Numeric Rating Scale (NRS)
Time Frame: 3 months, 6 months
NRS total score ranges from 0-10 over a one week recall period with the higher score indicating increased pain. Absolute scores will be reported from NRS questionnaire completed at 3 and 6 month visit.
3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Anat Galor, MD, MSPH, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

February 26, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (Estimate)

March 8, 2016

Study Record Updates

Last Update Posted (Actual)

November 14, 2019

Last Update Submitted That Met QC Criteria

November 12, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20160095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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