Efficacy Study of FK-506 and Cyclosporine in Vernal Keratoconjunctivits (VKC)

NCT01068054 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2010-02-12

No results posted yet for this study

Summary

The study was a double-blind, parallel study to compare efficacy of 0.1% tacrolimus ophthalmic ointment vs 2% cyclosporine eye drops in children with vernal keratoconjunctivitis. The duration of the blinded period was 8 weeks followed with 4 weeks of open-period of tacrolimus ointment. The hypothesis was that tacrolimus was as effective as cyclosporine for the treatment of this condition.

Conditions

  • Keratoconjunctivitis, Vernal

Interventions

DRUG

tacrolimus

0.1% ointment,apply bid, 8 weeks

DRUG

cyclosporins

2% eyclosporine eye drops apply 1 drop to each eye QID

Sponsors & Collaborators

  • Siriraj Hospital

    lead OTHER

Principal Investigators

  • Pakit Vichyanond, MD · Siriraj Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2005-05-31
Completion
2005-05-31

Countries

  • Thailand

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01068054 on ClinicalTrials.gov