Safety and Efficacy of Topical Infliximab in Autoimmune Dry Eye Disease

Sponsor
Instituto de Oftalmología Fundación Conde de Valenciana
Study ID
NCT07671222
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Infliximab 0.1% — DRUG
    It uses topical infliximab at 1 mg/mL (0.1%) formulated in preservative-free 1% carboxymethylcellulose (CMC), administered as 1 drop in each eye four times daily for 6 weeks. The comparator is an identical vehicle (CMC 1% without infliximab), which helps isolate the effect of infliximab itself.
  • Loteprednol — DRUG
    The comparator is an identical vehicle (CMC 1% without infliximab), which helps isolate the effect of infliximab itself.

Study Details

Sjögren's syndrome is a condition in which the immune system attacks the body's moisture-producing glands. This often causes severe dry eye, leading to discomfort, irritation, blurred vision, and damage to the eye surface. Inflammation plays an important role in this process, and a protein called TNF-alpha is one of the key drivers. This study will test a new eye drop containing infliximab, a medication that blocks TNF-alpha. The goal is to see whether this treatment can safely improve symptoms and signs of severe dry eye in patients with Sjögren's syndrome.

Key Dates

Start date
Dec 31, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
38 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Infliximab group
    Arm A: Infliximab Group (Intervention) Participants assigned to this group will receive: Topical infliximab 1 mg/mL (0.1%) in CMC 1%, one drop in each eye four times daily (QID) Topical corticosteroid (loteprednol 0.5%), one drop in each eye QID (standard therapy) This group evaluates whether adding infliximab to standard therapy improves symptoms and ocular surface inflammation.
  • Active Comparator: Vehicle group
    Participants assigned to this group will receive: Vehicle (CMC 1%) eye drops without infliximab, one drop in each eye four times daily (QID) Topical corticosteroid (loteprednol 0.5%), one drop in each eye QID (standard therapy) Preservative-free artificial tears as needed (rescue treatment) This group serves as the control, allowing comparison against standard treatment plus vehicle.

Primary Outcome Measure

Change in Ocular Surface Disease Index (OSDI) [ Time Frame: 6 weeks. ]

Central Contacts

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