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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02701764
• Other study ID #: 20160095
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 26, 2016
• Est. completion date: December 1, 2018

Study information

• Verified date: November 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Pregabalin

• Placebo

Locations

Country	Name	City	State
United States	Anat Galor	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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.	3 months, 6 months
Secondary	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.	3 months, 6 months
Secondary	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.	3 months, 6 months
Secondary	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.	3 months, 6 months
Secondary	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.	3 months, 6 months
Secondary	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.	3 months, 6 months
Secondary	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.	3 months, 6 months