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Immunosuppressant

Cyclosporine Eye Drops for Dry Eye Syndrome

Phase 4
Waitlist Available
Led By Vishal Jhanji, MD
Research Sponsored by Vishal Jhanji
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 last follow-up (month 6).
Awards & highlights

Study Summary

This trial will evaluate the effectiveness of a new, higher concentration cyclosporine eye drop in treating dry eye, compared to the current standard of care.

Who is the study for?
This trial is for adults over 18 with Dry Eye Syndrome who haven't been treated with drugs for this condition. They must have an OSDI score above 12, indicating moderate to severe symptoms. It's not open to those under 18, anyone unable to consent, or patients already using Cequa.Check my eligibility
What is being tested?
The study tests a new higher concentration (0.09%) of Cyclosporine eye drops against standard artificial tears in treating Dry Eye Syndrome. Researchers will measure changes in inflammation markers on the ocular surface before and after treatment.See study design
What are the potential side effects?
Cyclosporine may cause side effects like eye burning, redness, tearing, discharge, pain, itching; vision problems; or feeling as if something is in the eye.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~last follow-up (month 6).
This trial's timeline: 3 weeks for screening, Varies for treatment, and last follow-up (month 6). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tear Film Cytokines
Secondary outcome measures
OSDI Score

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cyclosporine + Artificial TearsExperimental Treatment2 Interventions
Cyclosporine eye drops twice daily (Treatment) with preservative-free artificial tear drops 4 times a day (Control).
Group II: Artificial TearsExperimental Treatment1 Intervention
Preservative-free artificial tear drops 4 times a day (Control).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Artificial tear
2013
Completed Phase 4
~470
Cyclosporine
1997
Completed Phase 3
~1830

Find a Location

Who is running the clinical trial?

Sun Pharmaceutical Industries LimitedIndustry Sponsor
64 Previous Clinical Trials
13,511 Total Patients Enrolled
Vishal JhanjiLead Sponsor
1 Previous Clinical Trials
Vishal Jhanji, MDPrincipal InvestigatorUPMC Eye Center
1 Previous Clinical Trials

Media Library

Cyclosporine (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT04515329 — Phase 4
Dry Eye Syndrome Research Study Groups: Cyclosporine + Artificial Tears, Artificial Tears
Dry Eye Syndrome Clinical Trial 2023: Cyclosporine Highlights & Side Effects. Trial Name: NCT04515329 — Phase 4
Cyclosporine (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04515329 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given clearance to Artificial tear for consumer use?

"The safety of artificial tear has been thoroughly assessed, thus receiving a score of 3. Such a high rating is attributed to this being an FDA-approved phase 4 trial."

Answered by AI

Are applications presently being accepted for this scientific experiment?

"This experiment is no longer recruiting patients, in spite of having been posted on the clinicaltrials.gov website on November 1st 2022 and last modified September 7th 2022. Nevertheless, there are 149 medical trials currently accepting memberships into their studies."

Answered by AI

What other empirical investigations involving Artificial tear have been conducted?

"Currently, there are 67 trials in progress examining the potential of Artificial tear. 12 of these investigations have reached Phase 3 and most originate from Aurora, Colorado. However, across 470 separate medical sites around the world, this drug is being tested for safety and efficacy."

Answered by AI

How many participants is the trial accommodating?

"Sadly, this trial is no longer recruiting. The first post was on November 1st 2022 and the study's last edit occured on September 7th 2022. If you are searching for other medical trials related to dry eyes or artifical tears, there are currently 82 studies and 67 studies respectively that are still accepting participants."

Answered by AI

In what contexts is artificial tear regularly employed?

"Artificial tear is often the most effective course of action for treating transplantation. There are also various other maladies that may benefit from artificial tear, including lupus nephritis, bulla and excessive tearing."

Answered by AI
~0 spots leftby Apr 2025