Tangible Hydra-PEG: A Promising Solution for Scleral Lens Wearers With Dry Eye

Completed · Not applicable

Conditions studied: Dry Eye, Dry Eye Syndromes

In brief

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 contact lens discomfort and dry eye symptoms with Tangible Hydra-PEG treated scleral lens wear compared to untreated scleral lens wear in the dry eye patient population.

Key facts

Study ID

NCT03417505

Run by

Tangible Science

People needed

21

Starts

2018-01-30

Expected to finish

2019-01-04

Last updated by the study team

2020-01-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California, Davis — Sacramento, California, United States
• Nova Southeastern University — Fort Lauderdale, Florida, United States
• Illinois College of Optometry — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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