CEQUA for Sjogren's Syndrome Dry Eye

NCT04835623 | Completed Phase 4 FDA Drug

• 1 other identifier: SP-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye; Dry Eye Syndromes; Sjogren's Syndrome

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in total corneal staining

  Expanded NEI corneal staining scale ranging from 0 to 15

  Baseline and week 12

Secondary Outcomes (2)

• Mean change from baseline in total conjunctival staining

  Baseline and week 12

• Mean change from baseline in the score of dry eye questionnaires

  Baseline and week 12

Study Arms (1)

Cyclosporine

EXPERIMENTAL

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

Drug: Cyclosporine 0.09% Ophthalmic Solution

Interventions

Cyclosporine 0.09% Ophthalmic Solution DRUG

one drop each eye twice daily

Also known as: Cequa Ophthalmic Product

Cyclosporine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center for Ophthalmic and Vision Research, LLC: lead
• Sun Pharmaceutical Industries Limited: collaborator

Study Sites (1)

Center for Ophthalmic and Vision Recearch

Manhattan, New York, 10022, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Sjogren's Syndrome

Interventions

Cyclosporine; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• John Rocco Robilotto, OD, PhD

  Center for Ophthalmic and Vision Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 8, 2021
• Study Start: June 21, 2021
• Primary Completion: March 21, 2024
• Study Completion: March 21, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)