12 Participants Needed

Tear Film Interventions for Tear Film Characteristics

(GAMBIA Trial)

JW
LJ
Overseen ByLyndon Jones, PhD, DSc, FCOptom
Age: Any Age
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Waterloo
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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?

LJ

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

I am at least 17 years old and can legally consent.
I have signed the consent form.
I can follow instructions and keep appointments.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive Systane Complete eye drops and wear senofilcon A and somofilcon A contact lenses on different days

3 days
3 visits (in-person)

Follow-up

Participants are monitored for changes in higher order aberrations after each intervention

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Systane Complete Preservative-Free
Trial Overview The study tests if a device called CA-800 Corneal Analyzer can detect changes in the tear film after using Systane Complete Preservative-Free drops or wearing Senofilcon A or Somofilcon A contact lenses.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Experimental: Systane Complete/ Somofilcon A/ Senofilcon AExperimental Treatment3 Interventions
Group II: Experimental: Systane Complete / Senofilcon A/ Somofilcon AExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Waterloo

Lead Sponsor

Trials
132
Recruited
221,000+

Citations

Systane® lubricant eye drops in the management of ocular ...Overall, the results of these studies variously show that Systane Ultra is effective in reducing the signs and symptoms associated with dry eye, and is safe ...
Systane® Complete Preservative Free Lubricant Eye ...Systane Complete has been evaluated in several pre-clinical and clinical studies.8 PG-HPG nanoemulsion lubricant eye drops have been shown to improve dry eye ...
Efficacy of a new nanoemulsion artificial tear in dry eye ...A recent study performed in USA indicated that Systane COMPLETE MDPF significantly improved the quality of life and reduced dry eye symptoms for digital device ...
Understanding quality of life in digital device users who are ...Using Systane COMPLETE MDPF can significantly improve a symptomatic digital device user's quality of life and dry eye symptom scores when used approximately 4 ...
A Decade of Effective Dry Eye Disease Management with ...Overall, these findings confirm that HP guar in lubricant eye drops improves the adherence and retention of the ATP, improves tear stability and ...
SYSTANE® COMPLETE Preservative-Free Eye DropsSYSTANE® COMPLETE PF provides 8 hours of clinically proven relief for all major types of dry eye. Its preservative-free formula is ideal for sensitive eyes.
Evaluation of Systane Complete for the Treatment ...Systane Complete was found to safely and significantly improve CL comfort in symptomatic CL wearers.
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