A Study of KCT-0809 in Patients With Dry Eye Syndromes
Phase 2
Completed
- Conditions
- Dry Eye Syndromes
- Interventions
- Drug: PlaceboDrug: KCT-0809
- Registration Number
- NCT01211951
- Lead Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndromes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
- Corneal and conjunctival damage
- Insufficiency of lacrimal secretion or tear film instability
- Ocular symptom
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Exclusion Criteria
- Severe ophthalmic disorder
- Punctual plugs or surgery for occlusion of the lacrimal puncta
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - KCT-0809 ophthalmic solution, low dose KCT-0809 - KCT-0809 ophthalmic solution, medium dose KCT-0809 - KCT-0809 ophthalmic solution, high dose KCT-0809 -
- Primary Outcome Measures
Name Time Method Corneal-conjunctival staining scores 4 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Japan
🇯🇵Tohoku, Kanto, Chubu, Kansai, Kyushu region, Japan