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| Sponsor: | Astellas Pharma Inc |
|---|---|
| Information provided by: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00567762 |
Purpose
To investigate the efficacy and safety of FK506 ophthalmic suspension on eye symptoms in patients with vernal keratoconjunctivitis
| Condition | Intervention | Phase |
|---|---|---|
|
Keratoconjunctivitis Conjunctivitis |
Drug: FK506 Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Placebo-Controlled, Double-Masked Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Vernal Keratoconjunctivitis |
| Enrollment: | 56 |
| Study Start Date: | February 2004 |
| Study Completion Date: | September 2004 |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
FK506 ophthalmic suspension
|
Drug: FK506
Opthalmic suspension
|
|
2: Placebo Comparator
Base of eye drops
|
Drug: placebo
placebo eye drops
|
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.
Eligibility| Ages Eligible for Study: | 6 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Japan | |
| Hokkaido, Japan | |
| Tochigi, Japan | |
| Tokyo, Japan | |
| Osaka, Japan | |
| Kagoshima, Japan | |
| Kochi, Japan | |
| Miyazaki, Japan | |
| Ehime, Japan | |
| Study Chair: | Central Contact | Astellas Pharma Inc |
More Information
| Study ID Numbers: | FJ-506D-AC09 |
| Study First Received: | December 3, 2007 |
| Last Updated: | February 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00567762 History of Changes |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
|
Keratoconjunctivitis vernal keratoconjunctivitis FK506 Tacrolimus |
|
Corneal Diseases Conjunctivitis, Allergic Immune System Diseases Immunologic Factors Eye Diseases Physiological Effects of Drugs Conjunctivitis Tacrolimus |
Keratoconjunctivitis Immunosuppressive Agents Pharmacologic Actions Conjunctival Diseases Hypersensitivity Hypersensitivity, Immediate Keratitis |