Clinical trial NCT03417505: Tangible Hydra-PEG: A Promising Solution for Scleral Lens Wearers With Dry Eye
Official title: Tangible Hydra-PEG: A Promising Solution for Scleral Lens Wearers With Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Dry Eye Syndromes
Keywords: Contact lens discomfort
Scleral lens
Tangible Hydra-PEG
Lead sponsor: Tangible Science
Sponsor class: INDUSTRY
Collaborators: name: Nova Southeastern University
name: University of California, Davis
name: Illinois College of Optometry
First posted: 2018-01-31
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-masked crossover study
Primary purpose: SUPPORTIVE_CARE

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 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.

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 conventional therapies are often ineffective. Recently, scleral lenses have demonstrated to be a promising therapeutic and vision rehabilitative option for dry eye sufferers. Nonetheless, despite the benefits of scleral lenses for dry eye patients, inadequate wettability of scleral lenses with subsequent diminished comfort and visual clarity remains a concern for scleral lens wearers with dry eye.

Tangible Hydra-PEG (Tangible Science LLC, Menlo Park, CA, USA) is a novel coating technology designed to improve lens wettability, deposit resistance, and tear film breakup time, ultimately enhancing contact lens comfort. While studies have shown that Tangible Hydra-PEG technology can improve contact lens discomfort (CLD) in soft contact lens and gas permeable lens wearers, to our knowledge, no clinical research investigation has examined the benefits of this new coating on scleral lens wear in dry eye sufferers. As such, the aim of this study is to compare the CLD and DE symptoms of dry eye scleral lens wearers between Tangible Hydra-PEG treated scleral lens wear and untreated scleral lens wear. CLD and DE signs will also be assessed to corroborate our findings.

This will be the first randomized double masked cross-over study to examine CLD and DE symptoms of Tangible Hydra-PEG treated scleral lens wear compared to untreated scleral lens wear in the dry eye patient population. Tangible Hydra-PEG treated scleral lenses can potentially minimize CLD and DE symptoms, ultimately improving outcomes for patients coping with dry eye disease. This study will provide new information about this innovative technology and help practitioners envisage rehabilitative options which will best optimize the quality of life of this important 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.

Primary outcomes:
measure: Ocular Surface Tear Breakup Time
timeFrame: 30 days
measure: Corneal Fluorescein Staining
timeFrame: 30 days
measure: Ocular Surface Disease Index (OSDI) Questionnaire
timeFrame: 30 days
measure: Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
timeFrame: 30 days
Secondary outcomes:
measure: Tear Breakup Time Over the Surface of the Scleral Lens
timeFrame: 30 days
measure: Lid Wiper Epitheliopathy
timeFrame: 30 days
measure: Contact Lens-related Papillary Conjunctivitis
timeFrame: 30 days
measure: Temporal Conjunctival Lissamine Green Staining
timeFrame: 30 days
measure: Nasal Conjunctival Lissamine Green Staining
timeFrame: 30 days
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: Fort Lauderdale
country: United States
facility: Nova Southeastern University
state: Florida
city: Chicago
country: United States
facility: Illinois College of Optometry
state: Illinois
Study officials:
affiliation: Nova Southeastern University
name: Chandra Mickles, OD MS FAAO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mickles CV, Harthan JS, Barnett M. Assessment of a Novel Lens Surface Treatment for Scleral Lens Wearers With Dry Eye. Eye Contact Lens. 2021 May 1;47(5):308-313. doi: 10.1097/ICL.0000000000000754.