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

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pregabalin
Placebo
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dry Eye focused on measuring laser-assisted in situ keratomileusis, dry eye symptoms, LASIK, prevention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Anat Galor

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pregabalin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Dry Eye Symptoms as Evaluated by the Ocular Surface Disease Index (OSDI)
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.
Tear Production Measured by Schirmers Score
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.
Tear Evaporation Measured by Tear Break up Time (TBUT)
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.
Eye Pain as Evaluated by the Neuropathic Pain Symptom Inventory - Eye (NPSI-E)
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.
Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Sensory
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.
Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Affective
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.
Eye Pain as Assessed by the Numeric Rating Scale (NRS)
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.

Full Information

First Posted
February 26, 2016
Last Updated
November 12, 2019
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT02701764
Brief Title
Can Pregabalin Reduce the Frequency and Severity of Dry Eye Symptoms After Laser-assisted in Situ Keratomileusis?
Official Title
Can Pregabalin Reduce the Frequency and Severity of Dry Eye Symptoms After Laser-assisted in Situ Keratomileusis?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 26, 2016 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
laser-assisted in situ keratomileusis, dry eye symptoms, LASIK, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin
Arm Type
Experimental
Arm Description
Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total.
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Severity of Dry Eye Symptoms as Assessed by the Dry Eye Questionnaire - 5 (DEQ5)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Dry Eye Symptoms as Evaluated by the Ocular Surface Disease Index (OSDI)
Description
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.
Time Frame
3 months, 6 months
Title
Tear Production Measured by Schirmers Score
Description
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.
Time Frame
3 months, 6 months
Title
Tear Evaporation Measured by Tear Break up Time (TBUT)
Description
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.
Time Frame
3 months, 6 months
Title
Eye Pain as Evaluated by the Neuropathic Pain Symptom Inventory - Eye (NPSI-E)
Description
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.
Time Frame
3 months, 6 months
Title
Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Sensory
Description
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.
Time Frame
3 months, 6 months
Title
Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Affective
Description
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.
Time Frame
3 months, 6 months
Title
Eye Pain as Assessed by the Numeric Rating Scale (NRS)
Description
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.
Time Frame
3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anat Galor, MD, MSPH
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anat Galor
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25896684
Citation
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.
Results Reference
background
PubMed Identifier
33096271
Citation
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.
Results Reference
derived

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

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