NCT01068054

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2010

Completed
Last Updated

February 12, 2010

Status Verified

June 1, 2003

Enrollment Period

1.9 years

First QC Date

February 11, 2010

Last Update Submit

February 11, 2010

Conditions

Keratoconjunctivitis, Vernal

Keywords

vernal keratoconjunctivitisFK-506tacrolimuscyclosporinechildren

Outcome Measures

Primary Outcomes (1)

  • overall subjective ocular symptom scores

    8 weeks

Secondary Outcomes (2)

  • overall objective ocular signs

    8 weeks

  • overall side-effect scores

    8 weeks

Study Arms (2)

tacrolimus

ACTIVE COMPARATOR

Tacrolimus arm: active 0.1% tacrolimus eye ointment BID + placebo eye drops QID

Drug: tacrolimus

cyclosporine

ACTIVE COMPARATOR

2% cyclosporine eye drops apply QID + placebo eye ointment apply bid

Drug: cyclosporins

Interventions

tacrolimusDRUG

0.1% ointment,apply bid, 8 weeks

tacrolimus
cyclosporinsDRUG

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

cyclosporine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with clinical diagnosis of vernal keratoconjunctivitis

You may not qualify if:

  • coexisting ocular diseases such as glaucoma, other corneal disease, ocular infections, other coexisting systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

TacrolimusCyclosporins

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Pakit Vichyanond, MD

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2010

First Posted

February 12, 2010

Study Start

June 1, 2003

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

February 12, 2010

Record last verified: 2003-06

Locations

TH(1)