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Multicenter, randomised, double masked, controlled studies on the efficacy of Cyclosporine eye drop treatment in preventing Vernal Keratoconjunctivitis VKC relapses and in treating the acute phase. - ND

Multicenter, randomised, double masked, controlled studies on the efficacy of Cyclosporine eye drop treatment in preventing Vernal Keratoconjunctivitis VKC relapses and in treating the acute phase. - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-003689-32-IT
Enrollment
48
Registered
2007-01-18
Start date
2006-12-19
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

VERNAL KERATOCONJUNTIVITIS MedDRA version: 9.1 Level: HLGT Classification code 10021877 Term: Ocular infections, irritations and inflammations

Interventions

Trade Name: ZADITEN*COLL 20FL 0,4ML 0,025% Pharmaceutical Form: Eye drops, solution INN or Proposed INN: Ketotifen CAS Number: 34580-14-8 Concentration unit: mg milligram(s) Concentration type: equal

Sponsors

UNIVERSITA CAMPUS BIOMEDICO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: DIAGNOSIS OF VERNAL KERATOCONJUNCTIVITIS ADHERENCE TO PROTOCOL Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: CONCOMITANT OCULAR PATHOLOGIES CONTACT LENS PREGNACY FEEDING SYSTEMIC PATHOLOGIES ALLERGIES TO DRUGS

Design outcomes

Primary

MeasureTime frame
Main Objective: This study will be performed as multicenter, randomized, double-masked, controlled study. It aims to evaluate the efficacy of topical CsA in preventing relapses of VKC;Secondary Objective: This study will be performed as multicenter, randomized, double-masked, controlled study. It aims to evaluate the efficacy of topical CsA in treating the acute phases of the disease VKC ;Primary end point(s): REDUCTION OF RELAPSES—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026