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CEQUA for Sjogren's Syndrome Dry Eye

Primary Purpose

Dry Eye, Dry Eye Syndromes, Sjogren's Syndrome

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cyclosporine 0.09% Ophthalmic Solution
Sponsored by
Center for Ophthalmic and Vision Research, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Center for Ophthalmic and Vision RecearchRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cyclosporine

Arm Description

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

Outcomes

Primary Outcome Measures

Mean change from baseline in total corneal staining
Expanded NEI corneal staining scale ranging from 0 to 15

Secondary Outcome Measures

Mean change from baseline in total conjunctival staining
Expanded NEI conjunctival staining scale ranging from 0 to 20
Mean change from baseline in the score of dry eye questionnaires
Dry eye questionnaire score ranging from 0 to 28

Full Information

First Posted
April 5, 2021
Last Updated
February 8, 2023
Sponsor
Center for Ophthalmic and Vision Research, LLC
Collaborators
Sun Pharmaceutical Industries Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04835623
Brief Title
CEQUA for Sjogren's Syndrome Dry Eye
Official Title
Effects of CEQUA™ on Objective and Subjective Dry Eye Findings Associated With Sjogren's Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
March 20, 2024 (Anticipated)
Study Completion Date
March 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Ophthalmic and Vision Research, LLC
Collaborators
Sun Pharmaceutical Industries Limited

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Dry Eye Syndromes, Sjogren's Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cyclosporine
Arm Type
Experimental
Arm Description
Participants receive Cyclosporine 0.09% Ophthalmic Solution (Cequa), 1 drop, each eye, twice a day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Cyclosporine 0.09% Ophthalmic Solution
Other Intervention Name(s)
Cequa Ophthalmic Product
Intervention Description
one drop each eye twice daily
Primary Outcome Measure Information:
Title
Mean change from baseline in total corneal staining
Description
Expanded NEI corneal staining scale ranging from 0 to 15
Time Frame
Baseline and week 12
Secondary Outcome Measure Information:
Title
Mean change from baseline in total conjunctival staining
Description
Expanded NEI conjunctival staining scale ranging from 0 to 20
Time Frame
Baseline and week 12
Title
Mean change from baseline in the score of dry eye questionnaires
Description
Dry eye questionnaire score ranging from 0 to 28
Time Frame
Baseline and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
George Zikos, OD, MS
Phone
212-650-4888
Email
COVR@ea-ny.com
First Name & Middle Initial & Last Name or Official Title & Degree
John Rocco Robilotto, OD, PhD
Phone
212-650-4888
Email
COVR@ea-ny.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Rocco Robilotto, OD, PhD
Organizational Affiliation
Center for Ophthalmic and Vision Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Ophthalmic and Vision Recearch
City
Manhattan
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Zikos, OD, MS
Phone
212-650-4888
Email
COVR@ea-ny.com
First Name & Middle Initial & Last Name & Degree
John Rocco Robilotto, OD, PhD
First Name & Middle Initial & Last Name & Degree
John Rocco Robilotto, OD, PhD
First Name & Middle Initial & Last Name & Degree
George Zikos, OD, MS
First Name & Middle Initial & Last Name & Degree
Hanish Patel, OD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CEQUA for Sjogren's Syndrome Dry Eye

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