N/A
N=21
Tangible Hydra-PEG: A Promising Solution for Scleral Lens Wearers With Dry Eye
Dry Eye · Dry Eye Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT03417505 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Ocular Surface Tear Breakup Time — 3.81; 2.91 seconds — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Scleral lenses treated with Tangible Hydra-PEG (Device); Untreated scleral lenses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tangible Science
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Surface Tear Breakup Time |
3.81; 2.91 | <0.01 sig |
| PRIMARY Corneal Fluorescein Staining |
0.92; 1.40 | <0.05 sig |
| PRIMARY Ocular Surface Disease Index (OSDI) Questionnaire |
28.24; 35.10 | <0.01 sig |
| PRIMARY Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) |
11.89; 17.30 | <0.01 sig |
| SECONDARY Tear Breakup Time Over the Surface of the Scleral Lens |
5.88; 4.75 | >0.05 |
| SECONDARY Lid Wiper Epitheliopathy |
0.89; 1.41 | <0.05 sig |
| SECONDARY Contact Lens-related Papillary Conjunctivitis |
0.89; 1.45 | <0.01 sig |
| SECONDARY Temporal Conjunctival Lissamine Green Staining |
0.95; 1.23 | <0.05 sig |
| SECONDARY Nasal Conjunctival Lissamine Green Staining |
0.79; 1.03 | >0.05 |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03417505). 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.