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Treg Effector Function and Th2/Treg Ratio in Allergic Conjunctivitis: Effect of Desensitization Therapy

Study acronym: INMUNOREG
StatusNot Yet Recruiting
PhaseNot specified
Started
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Record status
This record was last updated September 17, 2025 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Start date: Sep 1, 2025 to Jan 1, 2026v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study aims to evaluate the effector function and expression of TIGIT and PD-1 on Tregs, as well as the Th2/Treg ratio, in patients with allergic conjunctivitis with and without desensitization therapy, compared to healthy controls. Peripheral blood and tear samples will be collected once at enrollment. Treg and Th2 populations will be immunophenotyped, TIGIT and PD-1 expression assessed, and functional assays performed. Cytokine and antibody (IgE, IgG4) concentrations will be measured in serum and tears. Results will be analyzed using descriptive statistics, Shapiro-Wilk test for distribution, t-tests or ANOVA for group comparisons, and correlation analyses for associations, with p\<0.05 considered significant. This study seeks to identify immunological markers associated with disease severity and treatment response, potentially informing future therapeutic strategies.
Trial Details
NCT Number NCT07171307
Lead Sponsor Instituto de Oftalmología Fundación Conde de Valenciana
Conditions
(from sponsor)		 Conjunctivitis, Allergic
Related terms Conjunctivitis, Allergic
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov