Trial intelligence / Profile preview

Cyclosporine 0.05% for Diabetic Dry Eye

NCT06824844Phase 4

Key facts

Status
Completed
Start
Dec 2021
Primary completion
Mar 2024
Countries
1
Sponsor
Peking University Third Hospital
Modality
Peptides, Small Molecules
Conditions
dry eye disease (DED)
01

Overview

Phase 4, randomised trial of cyclosporine in dry eye disease (DED) (2 arms), sponsored by Peking University Third Hospital. Primary endpoints: Ocular Surface Disease Index at 3 months, Tear Break-up Time at 3 months and 3 more. Started Dec 2021; status: completed.

02

Design

2 arms
Study design
Randomized
  • Cyclosporine + Artificial Tears

    0.05% cyclosporine eyedrops (bid) + artificial tear eyedrops (qid)

  • Artificial Tears

    Artificial tear eyedrops (qid)

03

Who it enrols

Diabetic patients (Type 2, >= 5 years) aged 50-70 with diagnosed dry eye disease, excluding those with active ocular infection/inflammation, severe blepharitis, or corneal nerve diseases.

04

Endpoints

Primary

  • Ocular Surface Disease Index

  • Tear Break-up Time

  • Corneal Fluorescein Staining

  • Schirmer I Test

  • Lissamine Green Staining

Secondary

  • Corneal Sensitivity

  • Interleukin-1beta Concentration

  • Interleukin-6 Concentration

  • Interleukin-10 Concentration

  • Interleukin-17A Concentration

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