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Immunosuppressant

Artificial tear for Dry Eye Syndrome

UPMC Eye Center, Pittsburgh, PA
Artificial tear +1 morePhase 4Waitlist AvailableLed by Vishal Jhanji, MDResearch Sponsored by Vishal Jhanji

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.

Eligible Conditions
  • Dry Eye Syndrome

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with Dry Eye, but you haven't been given a prescription for any medication to treat it.
Select...
You have significant difficulties with your eyes, as indicated by a score higher than 12 on a special test called OSDI.

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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~320
Cyclosporine
FDA approved

Find a site

Who is running the clinical trial?

Sun Pharmaceutical Industries LimitedIndustry Sponsor
61 Previous Clinical Trials
13,433 Total Patients Enrolled
Vishal JhanjiLead Sponsor
1 Previous Clinical Trials
300 Total Patients Enrolled
Vishal Jhanji, MDPrincipal Investigator
UPMC Eye Center
1 Previous Clinical Trials
300 Total Patients Enrolled

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
Recent research and studies
clinicaltrials.govStudy
Tear Film Markers in Dry Eye Syndrome
Vishal Jhanji 2023. "Tear Film Markers in Dry Eye Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04515329.
~33 spots leftby Dec 2024
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