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OpenTrials
Completed

NCT Number: NCT02701764

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Anat Galor

Miami, Florida, 33133, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin

Drug

Placebo

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 8, 2016
Registry last updated
Nov 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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