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Tear Film Markers in Dry Eye Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04515329
Recruitment Status : Not yet recruiting
First Posted : August 17, 2020
Last Update Posted : January 8, 2021
Sponsor:
Collaborator:
Sun Pharma Global FZE
Information provided by (Responsible Party):
Vishal Jhanji, University of Pittsburgh

Brief Summary:
Dry eye is the most common reason for visit to an ophthalmologist's office. The prevalence is on the rise and is mainly attributed to factors such as increased environmental pollution and contact lens use. The current management options are limited to over the counter artificial tear drops and three FDA-approved drugs. Of these, cyclosporine has been used worldwide for treating mild to moderate dry eyes. The earlier version consisted of 0.05% cyclosporine which worked well for a limited number of inflammatory dry eye conditions. Recently, 0.09% cyclosporine was approved by the FDA. The nearly double concentration is expected to be more beneficial for severe inflammation which is often seen in Sjögren syndrome and other Rheumatological conditions associated with dry eyes. In this pilot project, the investigator proposes to evaluate the change in expression of SLURP1 and other markers of ocular surface inflammation before and after treatment with 0.09% cyclosporine eye drops.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Cyclosporine Drug: Artificial tear Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  • Study arm: Treatment will be commenced with cyclosporine eye drops twice daily with preservative-free artificial tear drops 4 times a day (Treatment).
  • Control arm: Preservative-free artificial tear drops 4 times a day (Control).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tear Film Markers in Dry Eye Syndrome: Impact of Immunomodulatory Therapy
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : January 3, 2023
Estimated Study Completion Date : January 3, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Cyclosporine + Artificial Tears
Cyclosporine eye drops twice daily (Treatment) with preservative-free artificial tear drops 4 times a day (Control).
Drug: Cyclosporine
Eye drops taken twice daily.
Other Name: Cequa

Drug: Artificial tear
Preservative-free artificial tear drops 4 times a day.
Other Name: Preservative-free artificial tears

Artificial Tears
Preservative-free artificial tear drops 4 times a day (Control).
Drug: Artificial tear
Preservative-free artificial tear drops 4 times a day.
Other Name: Preservative-free artificial tears




Primary Outcome Measures :
  1. Tear Film Cytokines [ Time Frame: At the time of sample collection (Baseline and Month 6). ]
    Change from Baseline in tear film cytokines at 6 months. The tear fluid samples would be analyzed by ELISA for: Matrix metalloproteinase-9; SLURP-1; HLA-DR5; IL-1RA; IL-6; and IL-8.


Secondary Outcome Measures :
  1. OSDI Score [ Time Frame: Last follow-up (Month 6). ]

    Change is Ocular Surface Disease Index (OSDI) score at Month 6.

    The OSDI quickly assesses the symptoms of ocular irritation in dry eye disease and how they affect functioning related to vision. This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time." A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with Dry Eye, but who have not been prescribed a drug to treat this condition.
  • 18 years of age and older
  • OSDI score > 12

Exclusion Criteria:

  • Younger than 18 years of age.
  • Any other associated eye diseases other than Dry Eye.
  • Inability to understand and give informed consent.
  • Patients diagnosed with Dry Eye who are already using Cequa.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04515329


Contacts
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Contact: Michael J DeRosa, BS, BA 412-647-3343 derosamj@upmc.edu
Contact: Rose Carla Aubourg, BA 412-647-3373 aubourgrc@upmc.edu

Locations
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United States, Pennsylvania
UPMC Eye Center
Pittsburgh, Pennsylvania, United States, 15213
Contact: Michael J DeRosa, BS; BA    412-647-3343    derosamj@upmc.edu   
Contact: Rose Carla Aubourg, BA    412-647-3373    aubourgrc@upmc.edu   
Principal Investigator: Vishal Jhanji, MD         
Sponsors and Collaborators
Vishal Jhanji
Sun Pharma Global FZE
Investigators
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Principal Investigator: Vishal Jhanji, MD UPMC Eye Center
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Responsible Party: Vishal Jhanji, Professor - Cornea Service, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04515329    
Other Study ID Numbers: STUDY20010206
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Cyclosporine
Lubricant Eye Drops
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Ophthalmic Solutions
Pharmaceutical Solutions