CEQUA for Sjogren's Syndrome Dry Eye

Effects of CEQUA™ on Objective and Subjective Dry Eye Findings Associated With Sjogren's Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Dry Eye Syndromes; Sjogren's Syndrome
• Intervention / Treatment: Drug: Cyclosporine 0.09% Ophthalmic Solution

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 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhattan, New York, United States, 10022
      • Center for Ophthalmic and Vision Recearch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cyclosporine; Participants receive Cyclosporine 0.09% Ophthalmic Solution (Cequa), 1 drop, each eye, twice a day for 12 weeks	Drug: Cyclosporine 0.09% Ophthalmic Solution; one drop each eye twice daily; Other Names: Cequa Ophthalmic Product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline in total corneal staining	Expanded NEI corneal staining scale ranging from 0 to 15	Baseline and week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline in total conjunctival staining	Expanded NEI conjunctival staining scale ranging from 0 to 20	Baseline and week 12
Mean change from baseline in the score of dry eye questionnaires	Dry eye questionnaire score ranging from 0 to 28	Baseline and week 12

Collaborators and Investigators

• Sponsor: Center for Ophthalmic and Vision Research, LLC
• Collaborators: Sun Pharmaceutical Industries Limited
• Investigators: Principal Investigator: John Rocco Robilotto, OD, PhD, Center for Ophthalmic and Vision Research

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Actual): March 21, 2024
• Study Completion (Actual): March 21, 2024

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Sjogren's Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Pharmaceutical Solutions; Calcineurin Inhibitors; Ophthalmic Solutions; Cyclosporine; Cyclosporins
• Other Study ID Numbers: SP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No