CEQUA for Sjogren's Syndrome Dry Eye

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04835623
• Other study ID #: SP-001
• Status: Completed
• Phase: Phase 4
• Start date: June 21, 2021
• Est. completion date: March 21, 2024

Study information

• Verified date: April 2024
• Source: Center for Ophthalmic and Vision Research, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 21, 2024
• Est. primary completion date: March 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Sjogren's Syndrome
• Syndrome

Intervention

Drug:
• Cyclosporine 0.09% Ophthalmic Solution
one drop each eye twice daily

Locations

Country	Name	City	State
United States	Center for Ophthalmic and Vision Recearch	Manhattan	New York

Sponsors (2)

Lead Sponsor	Collaborator
Center for Ophthalmic and Vision Research, LLC	Sun Pharmaceutical Industries Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in total corneal staining	Expanded NEI corneal staining scale ranging from 0 to 15	Baseline and week 12
Secondary	Mean change from baseline in total conjunctival staining	Expanded NEI conjunctival staining scale ranging from 0 to 20	Baseline and week 12
Secondary	Mean change from baseline in the score of dry eye questionnaires	Dry eye questionnaire score ranging from 0 to 28	Baseline and week 12