- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04515329
Tear Film Markers in Dry Eye Syndrome
Tear Film Markers in Dry Eye Syndrome: Impact of Immunomodulatory Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects will be recruited based on their diagnosis of dry eyes and an estimate of the severity of the disease that would be made by the investigator based on the patient's history and clinical examination.
Dry Eye Severity is determined by scoring > 12 on the Ocular Surface Disease Index (OSDI) rubric, which is standard practice.
Patients who have been diagnosed with dry eye, but who have not been prescribed a drug to treat that condition, will be recruited.
After signing a consent form, subjects will complete their routine care eye exam.
The PI will include consecutive patients for each arm. Once the mandate is completed in both arms, the investigator will stop the recruitment. The investigator will include patients who will choose to use artificial tear drops in one group. For the other group, the investigator will choose patients who would electively agree to use cyclosporine eyedrops. If these patients choose not to be a part of the study, they will still end up using the treatment that they would like to use.
- 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).
Eye drop timetable:
- If instructed to take 4 times a day, the subject will instill one drop in the morning, the afternoon, the early evening, and before bedtime.
- If instructed to take 2 times a day, the subject will instill one drop in the morning and the evening.
- Subjects will also be instructed to space eye drops by 3-5 minutes.
Both the Cyclosporine and Artificial Tears will be ordered by the subject's doctor, which will be available through the subject's pharmacist. These drops are normally prescribed as part of the subject's routine care.
Both subjects and physicians will be aware of the type of treatment; however the data entry and analysis would be blinded. This will be done by giving each individual subject a linking code.
Subjects will self-administer the eyedrops for 8 weeks.
---------------------------------------------------------
Research Procedures:
The following samples would be collected at baseline and at Week 8:
Baseline (Visit 1):
- Randomization
- Tear Fluid Collection
- Impression Cytology
Week 4 (Visit 2):
• Data collection: Subject will follow up normally with their ophthalmologist as part of their routine care eye exam. The following will be collected: Demographics; Clinical History and office visits; Images and Photography; and Microbiology records.
Week 8 (Visit 3):
- Tear Fluid Collection
- Impression Cytology
Visits 1 and 3 will add up to 20 minutes to the participant's routine care eye exam.
---------------------------------------------------------
Explanation of Procedures:
Numbing Anesthesia Drop (Proparacaine 0.5%):
Subject will receive a numbing anesthesia drop (Proparacaine 0.5%) in the eye that is inflamed as part of their standard of care. The effect of this drop will wear off in 20 minutes after instillation, but the subject is not required to stay until the numbing subsides.
Tear Fluid Collection (Schirmer Testing):
A small amount of the subject's tears will be collected by placing paper strips in the corner of their eye.
Impression Cytology:
The investigators will collect a single sample of material from the surface of the subject's eye and then evaluate it on a cellular level. During impression cytology the subject will be asked to look straight ahead with their chin slightly lifted. A drop of anesthetic eye drops is instilled in the lower fornix of the eye. The plunger of the impression cytology device (EYEPRIM; OPIA Technologies SAS, Paris, France, or equivalent) is pushed to touch the cornea with the membrane gently for 5 seconds. The pressure is released before removing the device. The membrane is then carefully transferred from the device into a 1.5-mL tube using a pair of sterile forceps. Multiple EYEPRIM membranes may be collected. One drop of artificial tear drop would be instilled on the surface of the eye. The participant would be asked to close his/her eye for a few seconds. A capillary tube or Schirmer's strip would be used to collect the tear film.
The total duration of research procedures will be approximately 20 minutes.
---------------------------------------------------------
Samples:
Microbiology analysis will be processed at the UPMC Eye Center's Ophthalmology Microbiology Lab.
The tear fluid samples would be analyzed by ELISA for:
- Matrix metalloproteinase-9
- SLURP-1
- HLA-DR5
- IL-1RA,
- IL-6, and
- IL-8
Impression cytology samples would be used to isolate total RNA, which will be converted to cDNA and used for QPCR evaluation of corresponding transcripts for the above targets. QPCRs along with ELISAs would provide convincing evidence to elucidate the effect(s) of 0.09% cyclosporine on expression of these markers of ocular surface inflammation. At the end of the study, the subject assignments will be unmasked and the difference between the treatment and the control groups analyzed.
Study Type
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Michael J DeRosa, BS, BA
- Phone Number: 412-647-3343
- Email: derosamj@upmc.edu
Study Contact Backup
- Name: Rose Carla Aubourg, BA
- Phone Number: 412-647-3373
- Email: aubourgrc@upmc.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- UPMC Eye Center
-
Contact:
- Rose Carla Aubourg, BA
- Phone Number: 412-647-3373
- Email: aubourgrc@upmc.edu
-
Contact:
- Michael J DeRosa, BS; BA
- Phone Number: 412-647-3343
- Email: derosamj@upmc.edu
-
Principal Investigator:
- Vishal Jhanji, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cyclosporine + Artificial Tears
Cyclosporine eye drops twice daily (Treatment) with preservative-free artificial tear drops 4 times a day (Control).
|
Eye drops taken twice daily.
Other Names:
Preservative-free artificial tear drops 4 times a day.
Other Names:
|
Other: Artificial Tears
Preservative-free artificial tear drops 4 times a day (Control).
|
Preservative-free artificial tear drops 4 times a day.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At the time of sample collection (Baseline and Month 6).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Last follow-up (Month 6).
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Vishal Jhanji, MD, UPMC Eye Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Lacrimal Apparatus Diseases
- Keratoconjunctivitis
- Conjunctivitis
- Conjunctival Diseases
- Keratitis
- Corneal Diseases
- Dry Eye Syndromes
- Keratoconjunctivitis Sicca
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Antifungal Agents
- Pharmaceutical Solutions
- Calcineurin Inhibitors
- Ophthalmic Solutions
- Cyclosporine
- Cyclosporins
- Lubricant Eye Drops
Other Study ID Numbers
- STUDY20010206
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dry Eye
-
Gordon Schanzlin New VisionCompletedDry Eye | Dry Eye Disease | Evaporative Dry Eye | Kerato Conjunctivitis Sicca | Evaporative Dry Eye Disease | Dry Eye, EvaporativeUnited States
-
Kao (Taiwan) CorporationChang Gung Memorial HospitalCompletedEye Fatigue | Dry Eye SymptomTaiwan
-
Alcon ResearchCompletedVisual Performance | Dry Eye Symptoms
-
Alcon ResearchCompletedModerate to Severe Dry Eye
-
Singapore National Eye CentreCompleted
-
AllerganCompletedDry Eye Syndrome | Dry Eye DiseaseUnited States
-
Senju Pharmaceutical Co., Ltd.CompletedDry Eye Syndrome | Dry Eye DiseaseUnited States
-
Bausch & Lomb IncorporatedCompletedDry Eye Disease (DED)United States
-
Centre for Contact Lens ResearchCoopervision, Inc.CompletedContact Lens Related Dry EyeCanada
-
Singapore National Eye CentreCompleted
Clinical Trials on Cyclosporine
-
AllerganCompletedDry Eye SyndromesUnited States
-
NovartisCompletedMaintenance Liver Transplant Patients With New Onset Diabetes
-
AllerganCompleted
-
Hospital de Clinicas de Porto AlegreUniversity of Sao Paulo; Federal University of Rio Grande do SulTerminatedBipolar Disorder | Bipolar Depression | Bipolar Affective DisorderBrazil
-
SCAI TherapeuticsCompletedDry Eye SyndromesKorea, Republic of
-
Santen SASCompletedConjunctivitis, VernalFrance
-
Groupe d'Etude Therapeutique des Affections Inflammatoires...CompletedUlcerative Colitis | Steroid RefractoryFrance, Spain, Belgium, Finland, Italy
-
National Institute of Allergy and Infectious Diseases...TerminatedKidney TransplantationUnited States
-
AllerganCompletedAtopic ConjunctivitisCanada, Czech Republic, United States, Italy, Israel, New Zealand, Spain, India, Germany, Australia, France, United Kingdom
-
Novartis PharmaceuticalsCompletedLiver TransplantationGermany