Tear Film Interventions for Tear Film Characteristics
(GAMBIA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether a special eye device can detect changes in the tear film, the thin liquid layer on the eye's surface, when using certain eye drops or wearing contact lenses. Participants will use an eye drop called Systane Complete Preservative-Free and try two types of contact lenses to identify any differences. Individuals who typically wear soft contact lenses and have healthy eyes without active conditions may be suitable for this trial. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits a broader range of patients.
Do I need to stop taking my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.
What is the safety track record for these treatments?
Research shows that Systane Complete Preservative-Free eye drops are safe for use. Studies have found that these drops effectively ease dry eye symptoms and are generally well-tolerated. No serious side effects have been reported. They provide relief for about 8 hours, making them a good option for sensitive eyes. This information should reassure participants about the safety of using Systane Complete in this trial.12345
Why are researchers enthusiastic about this study treatment?
Researchers are excited about Systane Complete Preservative-Free and its combination with senofilcon A and somofilcon A contact lenses because they offer a new approach to managing tear film characteristics, which are crucial for eye comfort and health. Unlike traditional treatments that might focus solely on artificial tears or single-type contact lenses, this combination approach leverages a preservative-free lubricant to enhance eye moisture, followed by different types of advanced contact lenses on subsequent days. This method aims to improve both the quality and stability of the tear film, potentially offering enhanced comfort and vision clarity compared to current standard treatments.
What evidence suggests that the CA-800 Corneal Analyzer is effective for detecting changes in the tear film?
Research has shown that Systane Complete Preservative-Free eye drops effectively manage dry eye symptoms. Studies have found that these drops significantly reduce discomfort and improve quality of life for individuals with dry eyes, particularly those frequently using digital devices. The drops create a thin layer that maintains moisture and stability on the eye surface, alleviating symptoms like dryness and irritation. In this trial, participants will receive Systane Complete with either senofilcon A or somofilcon A lenses, depending on the study arm. Overall, research supports Systane Complete as a reliable choice for managing dry eyes.12367
Who Is on the Research Team?
Lyndon Jones, PhD, DSc, FCOptom
Principal Investigator
Centre for Ocular Research & Education
Are You a Good Fit for This Trial?
This trial is for individuals at least 17 years old with good vision (0.00 logMAR or better in each eye) and no more than mild astigmatism. Participants must wear spherical soft contact lenses regularly, be able to follow the study schedule, and have clear corneas without active eye diseases.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Systane Complete eye drops and wear senofilcon A and somofilcon A contact lenses on different days
Follow-up
Participants are monitored for changes in higher order aberrations after each intervention
What Are the Treatments Tested in This Trial?
Interventions
- Systane Complete Preservative-Free
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Waterloo
Lead Sponsor