Status:
ENROLLING_BY_INVITATION
Single Lipiflow Treatment to Reduce Pharmacologic Burden in DED
Lead Sponsor:
Dunes Eye Consultants
Collaborating Sponsors:
Johnson & Johnson
Conditions:
MGD-Meibomian Gland Dysfunction
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief Summary
Purpose: To evaluate the efficacy of vectored thermal pulsation treatment in subjects with a history of dry eye disease currently using a topical immunomodulator medication.
Detailed Description
Prospective, non-randomized, interventional study. Subjects with bilateral use of a topical immunomodulator drop and a history of dry eye disease were recruited to participate. All subjects underwent ...
Eligibility Criteria
Inclusion
- No prior history of meibomian gland treatment procedures LipiFlow, TearCare, or I-Lux
- lifitegrast or cyclosporine eye drops daily for a period of at least one year but not exceeding five years
- Meibograpy documneted retention of at least 50% of meibomian glands.
Exclusion
- evidence of meibomian gland dropout exceeding 50%
- ocular rosacea,
- ocular surgery within the preceding three months
- prior in-office thermal meibomian gland treatment
- ocular trauma within preceding three months
- ocular herpetic infection
- chronic or recurrent inflammation
- eyelid abnormalities affecting lid function ocular surface abnormalities compromising corneal integrity (eg, epithelial basement membrane dystrophy, corneal burn)
- pregnant
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06542276
Start Date
September 1 2023
End Date
September 1 2024
Last Update
August 12 2024
Active Locations (1)
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1
Dunes Eye Consultants
Dakota Dunes, South Dakota, United States, 57049