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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dry Eye, Dry Eye Syndromes

Intervention / Treatment
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* Device: Scleral lenses treated with Tangible Hydra-PEG
* Device: Untreated scleral lenses


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, double-masked crossover study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated followed by untreated<br>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). | Device: Scleral lenses treated with Tangible Hydra-PEG<br>* 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.<br>* Other names: Tangible Hydra-PEG is a hydrophilic PEG-based lens coating;Device: Untreated scleral lenses<br>* Scleral lenses without the Tangible Hydra-PEG treatment will serve as a control.<br>* Other names: control;|
| Experimental: Untreated followed by treated<br>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). | Device: Scleral lenses treated with Tangible Hydra-PEG<br>* 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.<br>* Other names: Tangible Hydra-PEG is a hydrophilic PEG-based lens coating;Device: Untreated scleral lenses<br>* Scleral lenses without the Tangible Hydra-PEG treatment will serve as a control.<br>* Other names: control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Tear Breakup Time | Tear breakup time of the ocular surface after wearing lenses | 30 days | 
| Corneal Fluorescein Staining | Fluorescein staining followed by assessment using the Oxford grading scale (0-5, where 5 indicates the most staining and therefore the most damage to the ocular surface) of the ocular surface after wearing Hydra-PEG treated lenses compared to control lenses | 30 days | 
| Ocular Surface Disease Index (OSDI) Questionnaire | Dry eye questionnaire to assess symptoms after wearing Hydra-PEG treated lenses compared to control lenses. Patients will be scored from 0 (no dry eye disease) to 100 (severe dry eye disease). | 30 days | 
| Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) | Validated dry eye questionnaire to assess symptoms after wearing Hydra-PEG treated lenses compared to control lenses. Scale is from 1 to 37, with higher scores indicating more dry eye symptoms. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Breakup Time Over the Surface of the Scleral Lens | Tear breakup time over the surface of the Hydra-PEG treated scleral lens compared to the control lens | 30 days | 
| Lid Wiper Epitheliopathy | Fluorescein and lissamine staining to assess lid wiper epitheliopathy using a grading scale to see if there is a change in the height and width of the staining of the lid wiper area with Hydra-PEG treated lenses compared to untreated control lenses. The lid wiper area is the portion of the marginal conjunctival epithelium of the upper eyelid that wipes the ocular surface or lens during blinking. Epitheliopathy is scored on a scale from 0 (best patient outcome) to 3 (worst patient outcome, more staining) on the basis of the horizontal and vertical extent of lid margin staining. | 30 days | 
| Contact Lens-related Papillary Conjunctivitis | Visual inspection for contact lens-related papillary conjunctivitis with scoring by the Efron grading scale for papillary conjunctivitis [0 (normal) to 4 (severe)] to assess changes after wear of Hydra-PEG treated lenses compared to control lenses. | 30 days | 
| Temporal Conjunctival Lissamine Green Staining | Temporal conjunctival lissamine green staining scored 0 (no staining) to 4 (most staining). | 30 days | 
| Nasal Conjunctival Lissamine Green Staining | Nasal conjunctival lissamine green staining scored from 0 (no staining) to 4 (most staining). | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tangible Hydra-PEG, Contact lens discomfort, Scleral lens