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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03417505
• Other study ID #: STM-0686
• Status: Completed
• Phase: N/A
• Start date: January 30, 2018
• Est. completion date: January 4, 2019

Study information

• Verified date: January 2020
• Source: Tangible Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 4, 2019
• Est. primary completion date: January 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• 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.
• Untreated scleral lenses
Scleral lenses without the Tangible Hydra-PEG treatment will serve as a control.

Locations

Country	Name	City	State
United States	Illinois College of Optometry	Chicago	Illinois
United States	Nova Southeastern University	Fort Lauderdale	Florida
United States	University of California, Davis	Sacramento	California

Sponsors (4)

Lead Sponsor	Collaborator
Tangible Science	Illinois College of Optometry, Nova Southeastern University, University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Surface Tear Breakup Time	Tear breakup time of the ocular surface after wearing lenses	30 days
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Temporal Conjunctival Lissamine Green Staining	Temporal conjunctival lissamine green staining scored 0 (no staining) to 4 (most staining).	30 days
Secondary	Nasal Conjunctival Lissamine Green Staining	Nasal conjunctival lissamine green staining scored from 0 (no staining) to 4 (most staining).	30 days