Tear Film Markers in Dry Eye Syndrome

NCT04515329 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: STUDY20010206
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Tear Film Cytokines

  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 Outcomes (1)

• OSDI Score

  Last follow-up (Month 6).

Study Arms (2)

Cyclosporine + Artificial Tears

EXPERIMENTAL

Cyclosporine eye drops twice daily (Treatment) with preservative-free artificial tear drops 4 times a day (Control).

Drug: Cyclosporine; Drug: Artificial tear

Artificial Tears

OTHER

Preservative-free artificial tear drops 4 times a day (Control).

Drug: Artificial tear

Interventions

Cyclosporine DRUG

Eye drops taken twice daily.

Also known as: Cequa

Cyclosporine + Artificial Tears

Artificial tear DRUG

Preservative-free artificial tear drops 4 times a day.

Also known as: Preservative-free artificial tears

Artificial Tears; Cyclosporine + Artificial Tears

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vishal Jhanji: lead
• Sun Pharmaceutical Industries Limited: collaborator

Study Sites (1)

UPMC Eye Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporine; Cyclosporins; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Officials

• Vishal Jhanji, MD

  UPMC Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor - Cornea Service

Model Details: * 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).

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 17, 2020
• Study Start: December 8, 2023
• Primary Completion: December 8, 2023
• Study Completion: December 8, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)