Clinical Trial Finder

CEQUA for Sjogren's Syndrome Dry Eye

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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 Criteria:

  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04835623
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Center for Ophthalmic and Vision Research, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 John Rocco Robilotto, OD, PhD
Principal Investigator Affiliation Center for Ophthalmic and Vision Research
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Dry Eye, Dry Eye Syndromes, Sjogren's Syndrome
Additional Details

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 study. Eligible participants will continue to the second visit the same day or up to 10 days later. During the second visit participants will answer questionnaires about their eyes and have their vision, eyes, and tears examined. All participants will be given CEQUA to use over the duration of the study. The same procedures will be repeated every four weeks for 3 months total.

Arms & Interventions

Arms

Experimental: Cyclosporine

Participants receive Cyclosporine 0.09% Ophthalmic Solution (Cequa), 1 drop, each eye, twice a day for 12 weeks

Interventions

Drug: - Cyclosporine 0.09% Ophthalmic Solution

one drop each eye twice daily

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Manhattan, New York

Status

Recruiting

Address

Center for Ophthalmic and Vision Recearch

Manhattan, New York, 10022

Site Contact

George Zikos, OD, MS

[email protected]

212-650-4888

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