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Immunosuppressant

CEQUA for Sjogren's Syndrome Dry Eye

Phase 4
Waitlist Available
Led By John Rocco Robilotto, OD, PhD
Research Sponsored by Center for Ophthalmic and Vision Research, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Self-reported complaints of ocular dryness for a period of at least 3 months
Clinical diagnosis of Sjogren's Syndrome.
Must not have
Use of ocular steroid within the 3 months.
Previous history of treatment failure with cyclosporine.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 12
Awards & highlights

Study Summary

This trial is testing whether a medication can improve symptoms of dry eye disease in people with Sjogren's Syndrome.

Who is the study for?
This trial is for individuals with Sjogren's Syndrome who have been experiencing dry eyes for at least three months and can travel to Manhattan, NY. It's not suitable for those who've used eye steroids recently, had no success with cyclosporine before, or are pregnant or planning pregnancy soon.Check my eligibility
What is being tested?
The study aims to determine if CEQUA (cyclosporine 0.09% ophthalmic solution) can relieve the symptoms of dry eye disease in patients diagnosed with Sjogren's Syndrome.See study design
What are the potential side effects?
Potential side effects may include a burning sensation in the eyes, eye redness, discharge, pain, itching or stinging; however individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have experienced dry eyes for at least three months and have reported it yourself.
Select...
You have been diagnosed with Sjogren's Syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
You have tried cyclosporine before and it didn't work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Staining method
Secondary outcome measures
Mean change from baseline in the score of dry eye questionnaires
Mean change from baseline in total conjunctival staining

Trial Design

1Treatment groups
Experimental Treatment
Group I: CyclosporineExperimental Treatment1 Intervention
Participants receive Cyclosporine 0.09% Ophthalmic Solution (Cequa), 1 drop, each eye, twice a day for 12 weeks

Who is running the clinical trial?

Center for Ophthalmic and Vision Research, LLCLead Sponsor
1 Previous Clinical Trials
75 Total Patients Enrolled
Sun Pharmaceutical Industries LimitedIndustry Sponsor
64 Previous Clinical Trials
13,461 Total Patients Enrolled
John Rocco Robilotto, OD, PhDPrincipal InvestigatorCenter for Ophthalmic and Vision Research

Media Library

Cyclosporine 0.09% Ophthalmic Solution (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT04835623 — Phase 4
Sjogren's Syndrome Research Study Groups: Cyclosporine
Sjogren's Syndrome Clinical Trial 2023: Cyclosporine 0.09% Ophthalmic Solution Highlights & Side Effects. Trial Name: NCT04835623 — Phase 4
Cyclosporine 0.09% Ophthalmic Solution (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04835623 — Phase 4
Sjogren's Syndrome Patient Testimony for trial: Trial Name: NCT04835623 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what ailment is Cyclosporine 0.09% Ophthalmic Solution typically prescribed?

"Cyclosporine 0.09% Ophthalmic Solution is a pharmacological remedy primarily used for transplantation, yet it can be beneficial in treating lupus nephritis, excessive tearing, and bulla as well."

Answered by AI

Are there any past research efforts involving Cyclosporine 0.09% Ophthalmic Solution?

"Presently, there are 67 studies ongoing for Cyclosporine 0.09% Ophthalmic Solution with 12 of these in the advanced Phase 3. The town of Aurora has several running trials, but across the United States as a whole 470 different medical centres have active research projects related to this drug treatment solution."

Answered by AI

Does this clinical investigation accommodate geriatric individuals?

"Patients interested in participating must be at least 18 years old and less than 70."

Answered by AI

What is the total sample size for this clinical experiment?

"Correct. The information on clinicaltrials.gov confirms that this medical research project, which was initially posted on June 21st 2021, continues to seek participants. Approximately 50 patients will be accepted at 2 distinct locations for the duration of the trial."

Answered by AI

Is it possible for me to take part in this medical investigation?

"This study is seeking 50 individuals between 18 and 70 years old that are suffering from sicca syndrome. Essential requirements for potential participants include a minimum duration of 3 months with reported dryness in the eyes, as well as best-corrected distance visual acuity no lower than 20/25 per eye."

Answered by AI

Is this experiment currently open for recruitment?

"Affirmative. Clinicaltrials.gov indicates that this clinical trial is currently accepting participants, having been initially advertised on June 21st 2021 and most recently updated on July 7th 2022. The research requires 50 people to be recruited from 2 locations."

Answered by AI

Is Cyclosporine 0.09% Ophthalmic Solution considered a secure method of treatment for individuals?

"Cyclosporine 0.09% Ophthalmic Solution has been authorised, making it eligible for a safety rating of 3 on our scale."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Pennsylvania
New York
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
What site did they apply to?
Center for Ophthalmic and Vision Recearch

Why did patients apply to this trial?

Ive had this chronic condition for awhile and I’d like to find a solution for it while hopefully helping others through the research study, too.
PatientReceived 1 prior treatment
I have used many different eye drops and I still wind up with dry, itchy, painful eyes. If there's something that could work better I'd be happy to try it.
PatientReceived no prior treatments
I have dry eye I wake up every morning with white stains by my right eye and was told by the ophthalmologist oh it’s just dry eye so I want to know what can stop it.
PatientReceived 1 prior treatment
I spent years in pain finally being diagnosed as ad hoc. As I look back I suspect my Mother and Uncle had it. Even now doctor’s believe it’s just dry mouth. Very frustrating.
PatientReceived 1 prior treatment
I have always suffered from severe dry eye but recently in the past year my muscles have been getting spasms everywhere I've gotten dark spots on my legs, been having issues with my kidneys and I'm also living with hiv.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

An overview of the complete time commitment including number of visits would be helpful. And would I expect any of the screening or meds to be painful?
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Phone Call
Most responsive sites:
  1. Center for Ophthalmic and Vision Recearch: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
CEQUA for Sjogren's Syndrome Dry Eye
2021. "CEQUA for Sjogren's Syndrome Dry Eye". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04835623.
~13 spots leftby Apr 2025
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