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Preliminary Clinical Study of the Effectiveness and Safety of Ocular Surface Microbiota Transplantation in the Treatment of Dry Eye Disease

StatusCompleted
PhasePhase 1/2
Started
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Record History

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  1. Start date: Oct 1, 2025 to Dec 1, 2025
    • Interventions: Ocular surface microbiota transplantation (Biological), placebo transplantation Group (Biological) to Ocular surface microbiota transplantation (Biological), placebo transplantation (Biological)
    • Study arms: 2 to 3
  2. Trial completed
    • Final enrollment: 30 participants (planned 40)
    • Interventions modified
    • Eligibility criteria expanded, about 36 words
  3. Trial status: Recruiting to Completed Show 6 more changesShow less
    • Enrollment target: estimated 40 to confirmed 30
    • Primary and study completion dates changed from estimate of Jul 1, 2026 to Jun 30, 2026
    • Interventions: Ocular surface microbiota transplantation (Biological), Placebo Group (Biological) to Ocular surface microbiota transplantation (Biological), placebo transplantation Group (Biological)
    • Eligibility criteria expanded, about 70 words
    • Secondary endpoints revised (6)
    • Site details revised
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Evaluate the efficacy and safety of ocular surface microbiota transplantation as an adjunctive therapy for dry eye, and explore its impact on the structure of the ocular surface microbiota.
Trial Details
NCT Number NCT07298811
Lead Sponsor Second Affiliated Hospital of Nanchang University
Conditions
(from sponsor)		 Dry Eye
Related terms Dry Eye Syndromes
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov