Phase III Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis

A Randomized, Placebo-controlled, Double-masked Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Vernal Keratoconjunctivitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00567762

Enrollment

Registered

2007-12-05

Start date

2004-02-29

Completion date

2004-09-30

Last updated

2014-09-01

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

Conditions

Keratoconjunctivitis, Conjunctivitis

Keywords

Keratoconjunctivitis, vernal keratoconjunctivitis, FK506, Tacrolimus

Brief summary

To investigate the efficacy and safety of FK506 ophthalmic suspension on eye symptoms in patients with vernal keratoconjunctivitis

Detailed description

0.1% FK506 ophthalmic suspension were administered twice-a-day to patients with vernal keratoconjunctivitis in whom treatment with topical anti-allergic agents had been ineffective. The primary efficacy endpoint was the mean change from the baseline (before the treatment)in total score for objective clinical signs at the final observation. The safety of FK506 ophthalmic suspension was also investigated.

Interventions

DRUGFK506

Opthalmic suspension

DRUGplacebo

placebo eye drops

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

Inclusion criteria

* Vernal keratoconjunctivitis patients diagnosed by Guideline of diagnosis and treatment of allergic conjunctival disease * Patients with type I reactions defined by skin testing, antibody measurement, etc. * Age over 6 years old

Exclusion criteria

* Subjects receiving systemic administration or subconjunctival injection of corticosteroid or immunosuppressants(ophthalmic and systemic medications) within 2-weeks of initiation of the study * Subjects needed to wear contact lenses during treatment period on a testing eye * Subjects complicating an eye infection

Design outcomes

Primary

Measure	Time frame
Mean change from the baseline (before the treatment) in total score for objective clinical signs at the final observation	4 weeks

Secondary

Measure	Time frame
Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign	Week 1, 2 and 4
Subjective symptom score (Visual Analog Scale)	4 weeks
The improvement rate of subjective symptoms	4 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026