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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-30

Study Completion Date

2019-01-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ocular Effects of Scleral Lens Wear on Dry Eye Patients

NCT05079321

Dry Eye

COMPLETED NA

Evaluation of Tangible Boost Replenishing System

NCT03073148

Contact Lens Solution

COMPLETED NA

A Prospective Study of Two Daily Disposable Contact Lenses

NCT01636986

Myopia

COMPLETED NA

Clinical Performance of 59% Hioxifilcon A vs. Marketed Hydrogel Contact Lenses in Habitual Hydrogel Wearers

NCT04986644

Refractive Error - Myopia Bilateral

COMPLETED NA

PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses

NCT04032457

Refractive Errors

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye Dry Eye Syndromes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, double-masked crossover study

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treated followed by untreated

Patients wear the Hydra-PEG treated scleral lenses for 30 days. After testing and a post contact lens wear washout period, these patients will then wear the untreated lenses for 30 days. In this arm, the intervention (scleral lenses treated with Tangible Hydra-PEG) is administered prior to the control treatment (untreated scleral lenses).

Group Type EXPERIMENTAL

Scleral lenses treated with Tangible Hydra-PEG

Intervention Type DEVICE

Scleral lenses treated with Tangible Hydra-PEG, a hydrophilic, PEG-based contact lens coating designed to improve lens wettability, deposit resistance, and tear film breakup time.

Untreated scleral lenses

Intervention Type DEVICE

Scleral lenses without the Tangible Hydra-PEG treatment will serve as a control.

Untreated followed by treated

Patients wear the untreated scleral lenses for 30 days. After testing and a post contact lens wear washout period, these patients will then wear the Hydra-PEG treated lenses for 30 days. In this arm, the intervention (scleral lenses treated with Tangible Hydra-PEG) is administered after the control treatment (untreated scleral lenses).

Group Type EXPERIMENTAL

Scleral lenses treated with Tangible Hydra-PEG

Intervention Type DEVICE

Scleral lenses treated with Tangible Hydra-PEG, a hydrophilic, PEG-based contact lens coating designed to improve lens wettability, deposit resistance, and tear film breakup time.

Untreated scleral lenses

Intervention Type DEVICE

Scleral lenses without the Tangible Hydra-PEG treatment will serve as a control.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Scleral lenses treated with Tangible Hydra-PEG

Scleral lenses treated with Tangible Hydra-PEG, a hydrophilic, PEG-based contact lens coating designed to improve lens wettability, deposit resistance, and tear film breakup time.

Intervention Type DEVICE

Untreated scleral lenses

Scleral lenses without the Tangible Hydra-PEG treatment will serve as a control.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tangible Hydra-PEG is a hydrophilic PEG-based lens coating control

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No