NCT04835623CompletedPhase 4
CEQUA for Sjogren's Syndrome Dry Eye
Effects of CEQUA™ on Objective and Subjective Dry Eye Findings Associated With Sjogren's Syndrome
Source: ClinicalTrials.gov · Last updated 16 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 5 Apr 2021
- Start date
- 21 Jun 2021
- Primary completion date
- 21 Mar 2024
- Lead sponsor
- Center for Ophthalmic and Vision Research, LLC
- Diseases
- Sjögren's disease
- NCT number
- NCT04835623
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 50
- From 21 Jun 2021 to the primary completion date, 21 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of ocular steroid within the 3 months.
- Previous history of treatment failure with cyclosporine.
- Use of any systemic or topical ocular medication that is known to cause or exacerbate dry eye.
Other illness
- Known hypersensitivity or contraindication to the study medication or any of its ingredients.
- 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.
Other
- Use of cyclosporine within the last 3 months.
- Currently pregnant or lactating.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for Ophthalmic and Vision Recearch Coordinator of this site? Confirm its status | Manhattan | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.