Phase 3
N=43
Can Pregabalin Reduce the Frequency and Severity of Dry Eye Symptoms After Laser-assisted in Situ Keratomileusis?
Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT02701764 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Severity of Dry Eye Symptoms as Assessed by the Dry Eye Questionnaire - 5 (DEQ5) — 6.6; 4.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pregabalin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of Dry Eye Symptoms as Assessed by the Dry Eye Questionnaire - 5 (DEQ5) |
6.6; 4.5 | — |
| SECONDARY Dry Eye Symptoms as Evaluated by the Ocular Surface Disease Index (OSDI) |
11.9; 11.0; 12.6; 12.3 | — |
| SECONDARY Tear Production Measured by Schirmers Score |
12.40; 15.90; 15.45; 15.05 | — |
| SECONDARY Tear Evaporation Measured by Tear Break up Time (TBUT) |
7.10; 9.54; 8.35; 9.05 | — |
| SECONDARY Eye Pain as Evaluated by the Neuropathic Pain Symptom Inventory - Eye (NPSI-E) |
2.70; 1.86; 2.81; 3.14 | — |
| SECONDARY Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Sensory |
0.65; 0.36; 0.48; 0.81 | — |
| SECONDARY Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Affective |
0.30; 0.18; 0.29; 0.43 | — |
| SECONDARY Eye Pain as Assessed by the Numeric Rating Scale (NRS) |
0.85; 0.27; 1.10; 0.38 | — |
Summary
Can Lyrica (Pregabalin) help prevent severe Dry Eye post 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
Data sourced from ClinicalTrials.gov (NCT02701764). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.