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Ocular Effects of Scleral Lens Wear on Dry Eye Patients

NCT05079321 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-05-06

Study results available
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Summary

The purpose of this study is to investigate the effects of scleral contact lens wear on a DE population using coated (Hydra-PEG) and uncoated (control) lenses. Symptoms of DE, quality of the tear film, quality of life, epithelial and overall corneal thickness, vision and comfort will be assessed before and after dispensing and wearing the lenses for four weeks.

Conditions

  • Dry Eye

Interventions

DEVICE

Hydra-PEG

Zen™ RC scleral lenses (Hydra-PEG coated)

DEVICE

Uncoated

Zen™ RC scleral lenses (non-coated)

Sponsors & Collaborators

  • University of Waterloo

    lead OTHER

Principal Investigators

  • Lyndon Jones, PhD, FCOptom · University of Waterloo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-14
Primary Completion
2023-08-28
Completion
2023-08-28
FDA Device
Yes

Countries

  • Canada

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 NCT05079321 on ClinicalTrials.gov