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

NCT03417505 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-01-18

Study results available
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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.

Conditions

  • Dry Eye
  • Dry Eye Syndromes

Interventions

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.

DEVICE

Untreated scleral lenses

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

Sponsors & Collaborators

  • Nova Southeastern University

    collaborator OTHER

  • University of California, Davis

    collaborator OTHER

  • Illinois College of Optometry

    collaborator OTHER

  • Tangible Science

    lead INDUSTRY

Principal Investigators

  • Chandra Mickles, OD MS FAAO · Nova Southeastern University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-30
Primary Completion
2019-01-04
Completion
2019-01-04
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03417505 on ClinicalTrials.gov