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Immunosuppressant
All participants for Dry Eye Syndrome
N/A
Recruiting
Research Sponsored by University of Waterloo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 10 minutes of drop instillation
Awards & highlights
Study Summary
This trial is testing if cooling eye drops with cyclosporine A can reduce the burning and stinging when applied to the eyes of those with dry eye disease.
Who is the study for?
This trial is for adults over 18 with dry eye disease, evidenced by specific scores on the Ocular Surface Disease Index and Strip meniscometry tests. It's not suitable for contact lens wearers, pregnant or breastfeeding individuals, those allergic to fluorescein, or patients with certain ocular conditions or taking medications that could affect the study.Check my eligibility
What is being tested?
The study examines whether refrigerating Cequa (0.09% cyclosporine A ophthalmic solution) makes it more comfortable to use for treating dry eye syndrome. The discomfort of burning and stinging upon application is a common issue being addressed.See study design
What are the potential side effects?
Patients using Cequa have reported discomfort such as burning and stinging sensations when applying the drops. These side effects may discourage continued use necessary for managing dry eye disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 10 minutes of drop instillation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 10 minutes of drop instillation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ocular discomfort score. A subjective questionnaire that queries participants' ocular discomfort. The instrument ranges from 0 (no discomfort) to 10 (maximum discomfort).
Trial Design
1Treatment groups
Experimental Treatment
Group I: All participantsExperimental Treatment1 Intervention
All participants will have a refrigerated 0.09% cyclosporine drop instilled in one eye, and a non-refrigerated 0.09% cyclosporine drop instilled in the other eye. The eye that receives the refrigerated drop is randomly determined.
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Who is running the clinical trial?
University of WaterlooLead Sponsor
124 Previous Clinical Trials
209,318 Total Patients Enrolled
Sun Pharmaceutical Industries LimitedIndustry Sponsor
64 Previous Clinical Trials
13,471 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any allergies to Cequa or conditions that prevent its use.I have a nerve-related corneal condition.I am over 18 years old.I am not pregnant or breastfeeding.I have a condition or take medication that might affect the study results.
Research Study Groups:
This trial has the following groups:- Group 1: All participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research project presently accepting participants?
"Affirmative. The clinicaltrials.gov website attests to the fact that this trial is currently accepting applicants, having been initially posted on May 19th 2023 and most recently edited on July 13th of the same year. 40 participants are needed from a single medical centre for participation in this study."
Answered by AI
What is the enrollment number for this medical experiment?
"Indeed, according to clinicaltrials.gov, this trial is currently open for enrollment. Initially posted on May 19th 2023 and most recently updated on July 13th 2023, the study seeks 40 participants from a single site."
Answered by AI
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