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Immunosuppressant

Cyclosporine ophthalmic solution, 0.1% (VEVYE) for Dry Eye Syndrome

Phase 4
Recruiting
Research Sponsored by Novaliq GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be at least 18 years of age
Have a subject reported history of dry eye disease (DED) in both eyes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

"This trial aims to see how well cyclosporine eye drops work on the health of eye cells compared to a saline solution in people with Dry Eye Disease."

Who is the study for?
This trial is for adults over 18 with a history of Dry Eye Disease (DED) in both eyes who can follow the study's instructions and attend all assessments. Participants must provide written consent to join.Check my eligibility
What is being tested?
The trial is testing the effects of Cyclosporine ophthalmic solution, 0.1% (VEVYE), against a saline solution on corneal endothelial cell health in people with DED.See study design
What are the potential side effects?
Cyclosporine may cause eye burning, redness, tearing, discharge, pain, itching, visual blurring or other vision changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I have a history of dry eye disease in both eyes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in corneal ECD

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Cyclosporine ophthalmic solution, 0.1% (VEVYE)Active Control1 Intervention
Cyclosporine ophthalmic solution, 0.1%; 12 months
Group II: Saline solution, 0.6%Placebo Group1 Intervention
Saline solution, 0.6%; 12 months

Find a Location

Who is running the clinical trial?

Novaliq GmbHLead Sponsor
11 Previous Clinical Trials
2,136 Total Patients Enrolled
Sonja Krösser, PhDStudy DirectorNovaliq GmbH
1 Previous Clinical Trials
24 Total Patients Enrolled

Frequently Asked Questions

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

At how many different venues can this clinical trial be accessed?

"At present, this research initiative is enrolling participants from 6 distinct sites, with bases in Torrance, Garner, and Shelby among others. Opting for the closest location to your residence is advisable to reduce travel requirements during potential participation."

Answered by AI

Is the current investigation open for participant enrollment?

"As per clinicaltrials.gov, this ongoing study is actively seeking volunteers. The trial was first made available on April 22nd, 2024 and most recently revised on May 2nd, 2024."

Answered by AI

What is the upper limit of participants who can be enrolled in this clinical investigation?

"Indeed, as per the information on clinicaltrials.gov, this particular medical trial is actively seeking participants. The original posting date was 22nd of April in the year 2024 and it received its latest update on the 2nd of May in that same year. This study aims to recruit a total of 200 patients distributed across six different sites."

Answered by AI

What are the safety profiles of Cyclosporine ophthalmic solution, 0.1% (VEVYE) in patients?

"The safety assessment for Cyclosporine ophthalmic solution, 0.1% (VEVYE) in this Phase 4 trial is rated as a 3 by our team at Power due to its approved status indicating high levels of safety and efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
CYS-007 Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I've tried other artificial tears, saline solutions which didn't work and/or were inconvenient.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine
2024. "A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06329661.
All > Anaheim > Greensboro
~133 spots leftby Nov 2025
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