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Tear Film Markers in Dry Eye Syndrome

NCT04515329 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2023-12-18

No results posted yet for this study

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

Interventions

DRUG

Cyclosporine

Eye drops taken twice daily.

DRUG

Artificial tear

Preservative-free artificial tear drops 4 times a day.

Sponsors & Collaborators

  • Sun Pharmaceutical Industries Limited

    collaborator INDUSTRY

  • Vishal Jhanji

    lead OTHER

Principal Investigators

  • Vishal Jhanji, MD · UPMC Eye Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-08
Primary Completion
2023-12-08
Completion
2023-12-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04515329 on ClinicalTrials.gov