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Immunosuppressant

Cyclosporine for Dry Eye Syndrome

Phase 4
Waitlist Available
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
Must not have
Be a woman who is pregnant, nursing, or planning a pregnancy
Have any primary or secondary corneal endothelial disorder such as Fuchs dystrophy or other endothelial dystrophy, significant guttata
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

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.
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.
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
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I am 18 years old or older.
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I have a history of dry eye disease in both eyes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, nursing, or planning to become pregnant.
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I have a corneal condition like Fuchs dystrophy.
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I do not have any eye or body infections currently.
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I have noticeable eye or eyelid issues seen during an eye exam.
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I have cancer in or around my eye.
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I have a chronic illness that is not well-managed.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in corneal ECD

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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
~102 spots leftby Jul 2025
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