Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis

Conjunctivitis Clinical Trial

Official title:

Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567918
• Other study ID #: FJ-506D-AC10
• Status: Completed
• Phase: Phase 3
• First received: December 3, 2007
• Last updated: April 3, 2008
• Start date: May 2004
• Est. completion date: January 2008

Study information

• Verified date: April 2008
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

To investigate the long-term efficacy and safety of FK506 ophthalmic suspension in patients with vernal keratoconjunctivitis

Description:

To give a chance of continuous use of 0.1% FK506 ophthalmic suspension to patients with vernal keratoconjunctivitis who were enrolled in the FJ-506D-AC09 study, long-term safety and efficacy were evaluated. Primary efficacy endpoint was the mean change from the baseline (before the treatment) in total score for objective clinical signs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Vernal keratoconjunctivitis patients who were enrolled in the FJ-506D-AC09 study

• Patients who wish to receive continuous administration of FK506 ophthalmic suspension

Exclusion Criteria:

• Subjects who needed prohibited concomitant therapy at the initiation of the study

• Subjects who needed to wear contact lenses during treatment period on a testing eye

• Subjects with complicating an eye infection

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Allergic
• Keratoconjunctivitis

Intervention

Drug:
• FK506
Ophthalmic suspension

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety		length of study	No
Secondary	The mean change from the baseline (before the treatment) in total score for objective clinical signs		length of study	No
Secondary	Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign		Length of study	No
Secondary	Subjective symptom score (Visual Analog Scale)		Length of study	No
Secondary	The improvement rate		Length of study	No