Status:
COMPLETED
Tangible Hydra-PEG: A Promising Solution for Scleral Lens Wearers With Dry Eye
Lead Sponsor:
Tangible Science
Collaborating Sponsors:
Nova Southeastern University
University of California, Davis
Conditions:
Dry Eye
Dry Eye Syndromes
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Tangible Hydra-PEG is a novel coating technology designed to improve lens wettability, deposit resistance, and tear film breakup time. This is a randomized double masked cross-over study to examine co...
Detailed Description
Dry eye (DE) is a common complaint of millions of people worldwide with a significant impact on quality of life. For decades, this condition has presented a challenge to eye care professionals as conv...
Eligibility Criteria
Inclusion
- Reduced tear film break up time (TBUT), a sign of dry eye disease and contact lens discomfort
- Scleral lens wearer (at least 8 hours per day for at least 5 days per week and have had their habitual lenses no longer than 1 year). Scleral lenses wear will be defined as 15.00 mm to 19.00 mm inclusive.
Exclusion
- Disorders that affect sensitivity (herpetic disease, severe diabetes mellitus)
- Anatomic variations of the conjunctiva that can impair proper scleral lens fitting
- Pregnancy
- Best corrected Snellen visual acuity worse than 20/30 in either eye
- Ocular pathology other than dry eye (e.g. glaucoma, macular degeneration, keratoconus) which may significantly impact visual function.
Key Trial Info
Start Date :
January 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2019
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03417505
Start Date
January 30 2018
End Date
January 4 2019
Last Update
January 18 2020
Active Locations (3)
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1
University of California, Davis
Sacramento, California, United States, 95825
2
Nova Southeastern University
Fort Lauderdale, Florida, United States, 33314
3
Illinois College of Optometry
Chicago, Illinois, United States, 60616