Tangible Hydra-PEG: A Promising Solution for Scleral Lens Wearers With Dry Eye
1 other identifier
interventional
21
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2018
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2018
CompletedStudy Start
First participant enrolled
January 30, 2018
CompletedFirst Posted
Study publicly available on registry
January 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2019
CompletedResults Posted
Study results publicly available
January 18, 2020
CompletedJanuary 18, 2020
January 1, 2020
11 months
January 10, 2018
December 20, 2019
January 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (5)
Tear Breakup Time Over the Surface of the Scleral Lens
30 days
Lid Wiper Epitheliopathy
30 days
Contact Lens-related Papillary Conjunctivitis
30 days
Temporal Conjunctival Lissamine Green Staining
30 days
Nasal Conjunctival Lissamine Green Staining
30 days
Study Arms (2)
Treated followed by untreated
EXPERIMENTALPatients 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).
Untreated followed by treated
EXPERIMENTALPatients 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).
Interventions
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.
Scleral lenses without the Tangible Hydra-PEG treatment will serve as a control.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tangible Sciencelead
- Nova Southeastern Universitycollaborator
- University of California, Daviscollaborator
- Illinois College of Optometrycollaborator
Study Sites (3)
University of California, Davis
Sacramento, California, 95825, United States
Nova Southeastern University
Fort Lauderdale, Florida, 33314, United States
Illinois College of Optometry
Chicago, Illinois, 60616, United States
Related Publications (1)
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.
PMID: 33156128DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Kelly Mabry
- Organization
- Tangible Science
Study Officials
- PRINCIPAL INVESTIGATOR
Chandra Mickles, OD MS FAAO
Nova Southeastern University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2018
First Posted
January 31, 2018
Study Start
January 30, 2018
Primary Completion
January 4, 2019
Study Completion
January 4, 2019
Last Updated
January 18, 2020
Results First Posted
January 18, 2020
Record last verified: 2020-01