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Comparison of Ocular Lubricants in People With Symptoms of Dry Eye

NCT07451184 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-28

No results posted yet for this study

Summary

Ocular dryness and discomfort are symptoms commonly associated with dry eye. Lubricating eye drops, also called artificial tears, are often used to moisten the eye and provide relief from these symptoms. There are currently several types of lubricating eye drops available, differing in their ingredients, consistency, and recommended frequency of application. The aim of this study is to compare the effectiveness of two lubricating eye drops that differ in their ingredients and recommended frequency of application. The goal is to see whether they perform the same or if one of them provides better relief for people with dry eye symptoms. One of the eye drops is commercially available in Canada, the other one is not commercially available in Canada and therefore considered an investigational eye drop. This eye drop is available in the United States of America. In this study, participants will use one drop twice per day and the other drop four times per day. Each product will be used for 4 weeks and all participants will use both products (one after the other). There will be a 2-week period of no drops between the two study products. Before starting each drop and after 4 weeks of drop use, we will assess the eyes of the participants and ask them how their eyes feel. Participants will also be asked to answer a series of questions regarding the drops. Participants will encounter procedures that they normally experience in an eye care setting. The results will help the funding company to better understand the performance of the products used in this study. It may also help eyecare practitioners in managing their patients with dry eye symptoms. The hypothesis is that the drop used twice a day will be non-inferior to the drop used 4 times per day for the change in dry eye symptoms (assessed with the Ocular Surface Disease Index questionnaire) after 4 weeks of use.

Conditions

  • Dry Eye Symptoms

Interventions

DRUG

Propylene glycol 0.6%

1 drop per eye multiple times per day for 4 weeks

DEVICE

3% trehalose and 0.15% sodium hyaluronate

1 drop per eye multiple times per day for 4 weeks

Sponsors & Collaborators

  • Alcon Research

    collaborator INDUSTRY

  • University of Waterloo

    lead OTHER

Principal Investigators

  • Jill Woods, MSc, MCOptom · Centre for Ocular Research & Education

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-23
Primary Completion
2027-05-23
Completion
2027-05-23
FDA Drug
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 NCT07451184 on ClinicalTrials.gov