Status:
COMPLETED
CEQUA for Sjogren's Syndrome Dry Eye
Lead Sponsor:
Center for Ophthalmic and Vision Research, LLC
Collaborating Sponsors:
Sun Pharmaceutical Industries Limited
Conditions:
Dry Eye
Dry Eye Syndromes
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to show that CEQUA (cyclosporine 0.09% ophthalmic solution) improves symptoms of dry eye disease in a population of patients with Sjogren's Syndrome diagnosis.
Detailed Description
After being informed about the study and potential risks, all participants giving informed consent will have an eye exam and will be asked about their medical history to determine eligibility for the ...
Eligibility Criteria
Inclusion
- Clinical diagnosis of Sjogren's Syndrome.
- Self-reported complaints of ocular dryness for a period of at least 3 months
- Best-corrected distance visual acuity of 20/25 or better in each eye.
Exclusion
- Use of cyclosporine within the last 3 months.
- Use of ocular steroid within the 3 months.
- Previous history of treatment failure with cyclosporine.
- Known hypersensitivity or contraindication to the study medication or any of its ingredients.
- Use of any systemic or topical ocular medication that is known to cause or exacerbate dry eye.
- Any active ocular infection.
- Severe or serious ocular condition in either eye or any other unstable medical condition that may preclude study treatment or follow-up.
- History or presence of chronic generalized systemic disease that might increase the risk to the subject or confound the results of the study.
- Currently pregnant or lactating.
Key Trial Info
Start Date :
June 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04835623
Start Date
June 21 2021
End Date
March 21 2024
Last Update
April 16 2024
Active Locations (1)
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1
Center for Ophthalmic and Vision Recearch
Manhattan, New York, United States, 10022