Clinical trial NCT02701764: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dry Eye
Keywords: laser-assisted in situ keratomileusis
dry eye symptoms
LASIK
prevention
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Severity of Dry Eye Symptoms as Assessed by the Dry Eye Questionnaire - 5 (DEQ5)
timeFrame: 6 months
Secondary outcomes:
measure: Dry Eye Symptoms as Evaluated by the Ocular Surface Disease Index (OSDI)
timeFrame: 3 months, 6 months
measure: Tear Production Measured by Schirmers Score
timeFrame: 3 months, 6 months
measure: Tear Evaporation Measured by Tear Break up Time (TBUT)
timeFrame: 3 months, 6 months
measure: Eye Pain as Evaluated by the Neuropathic Pain Symptom Inventory - Eye (NPSI-E)
timeFrame: 3 months, 6 months
measure: Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Sensory
timeFrame: 3 months, 6 months
measure: Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Affective
timeFrame: 3 months, 6 months
measure: Eye Pain as Assessed by the Numeric Rating Scale (NRS)
timeFrame: 3 months, 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Anat Galor
state: Florida
Study officials:
affiliation: University of Miami
name: Anat Galor, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.