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

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ClinicalTrials.gov Identifier: NCT03417505
Recruitment Status : Not yet recruiting
First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Collaborators:
Nova Southeastern University
University of California, Davis
Illinois College of Optometry
Information provided by (Responsible Party):
Tangible Science

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.

Condition or disease Intervention/treatment Phase
Dry Eye Dry Eye Syndromes Device: Scleral lenses treated with Tangible Hydra-PEG Device: Untreated scleral lenses Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, double-masked crossover study
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Tangible Hydra-PEG: A Promising Solution for Scleral Lens Wearers With Dry Eye
Estimated Study Start Date : January 30, 2018
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear Tears

Arm Intervention/treatment
Experimental: 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).
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.
Other Name: Tangible Hydra-PEG is a hydrophilic PEG-based lens coating

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

Experimental: 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).
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.
Other Name: Tangible Hydra-PEG is a hydrophilic PEG-based lens coating

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




Primary Outcome Measures :
  1. Change in ocular surface tear breakup time [ Time Frame: Assessment (day 1), baseline (day 9), post lens wear testing (day 40), baseline (day 48), post lens wear testing (day 79) ]
    Tear breakup time of the ocular surface after wearing Hydra-PEG treated lenses compared to control lenses

  2. Change in ocular surface staining [ Time Frame: Assessment (day 1), baseline (day 9), post lens wear testing (day 40), baseline (day 48), post lens wear testing (day 79) ]
    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

  3. Change in responses to Ocular Surface Disease Index (OSDI) questionnaire [ Time Frame: Assessment (day 1), baseline (day 9), post lens wear testing (day 40), baseline (day 48), post lens wear testing (day 79) ]
    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).

  4. Change in responses to the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) [ Time Frame: Assessment (day 1), baseline (day 9), post lens wear testing (day 40), baseline (day 48), post lens wear testing (day 79) ]
    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.


Secondary Outcome Measures :
  1. Change in tear breakup time over the surface of the scleral lens [ Time Frame: Assessment (day 1), baseline (day 9), post lens wear testing (day 40), baseline (day 48), post lens wear testing (day 79) ]
    Tear breakup time over the surface of the Hydra-PEG treated scleral lens compared to the control lens

  2. Change in lid wiper epitheliopathy [ Time Frame: Assessment (day 1), baseline (day 9), post lens wear testing (day 40), baseline (day 48), post lens wear testing (day 79) ]
    Fluorescein and lissamine staining to assess lid wiper epitheliopathy using a grading scale developed by Don Korb,OD 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.

  3. Change in contact lens-related papillary conjunctivitis [ Time Frame: Assessment (day 1), baseline (day 9), post lens wear testing (day 40), baseline (day 48), post lens wear testing (day 79) ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417505


Contacts
Contact: Chandra Mickles, OD MS FAAO 800-541-6682 cmickles@nova.edu
Contact: Judy Magnum 954-262- 1413 jmagnum@nova.edu

Locations
United States, California
University of California, Davis Not yet recruiting
Sacramento, California, United States, 95825
Contact: Melissa Barnett, OD FAAO FSLS    800-282-3284    barnettod@yahoo.com   
United States, Florida
Nova Southeastern University Not yet recruiting
Fort Lauderdale, Florida, United States, 33314
Contact: Chandra Mickles, OD MS FAAO    954-262-1464    cmickles@nova.edu   
United States, Illinois
Illinois College of Optometry Not yet recruiting
Chicago, Illinois, United States, 60616
Contact: Jennifer Harthan, OD FAAO FSLS    312-949-7137    jharthan@ico.edu   
Sponsors and Collaborators
Tangible Science
Nova Southeastern University
University of California, Davis
Illinois College of Optometry
Investigators
Principal Investigator: Chandra Mickles, OD MS FAAO Nova Southeastern University

Responsible Party: Tangible Science
ClinicalTrials.gov Identifier: NCT03417505     History of Changes
Other Study ID Numbers: STM-0686
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Tangible Science:
Contact lens discomfort
Scleral lens
Tangible Hydra-PEG

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases