Back to resultsTolerability, Safety and Efficacy of RKI983 Eye Drops in Subjects With Primary Open Angle Glaucoma and Ocular Hypertension
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RKI983
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Ocular Hypertension, RKI983, Primary Open Angle Glaucoma and Ocular Hypertension
Eligibility Criteria
Inclusion Criteria:
- Males and females, ≥18 years of age, with primary open angle glaucoma and ocular hypertension
- Females must be post-menopausal or surgically sterile
Exclusion Criteria:
- Other types of glaucoma
- Eye pressure lowering surgeries
- A history of or current eye conditions or medical problems that would prohibit the use of an investigational drug
Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
Outcomes
Primary Outcome Measures
Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, ECGs and vital signs over period of 7 days treatment.
Secondary Outcome Measures
Change in ocular hypertension from Baseline to Day 7.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00515424
Brief Title
Tolerability, Safety and Efficacy of RKI983 Eye Drops in Subjects With Primary Open Angle Glaucoma and Ocular Hypertension
Official Title
A Multicenter, Randomized, Placebo-Controlled, Latanoprost-Controlled, Parallel Group Study to Assess the Tolerability, Safety and Efficacy of RKI983 Ophthalmic Solution Given Twice a Day Over One Week in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the tolerability and safety of RKI983 ophthalmic solution and explore the effect of the compound on intraocular pressure in subjects with ocular hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
Keywords
Glaucoma, Ocular Hypertension, RKI983, Primary Open Angle Glaucoma and Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
90 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
RKI983
Primary Outcome Measure Information:
Title
Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, ECGs and vital signs over period of 7 days treatment.
Secondary Outcome Measure Information:
Title
Change in ocular hypertension from Baseline to Day 7.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Males and females, ≥18 years of age, with primary open angle glaucoma and ocular hypertension
Females must be post-menopausal or surgically sterile
Exclusion Criteria:
Other types of glaucoma
Eye pressure lowering surgeries
A history of or current eye conditions or medical problems that would prohibit the use of an investigational drug
Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Independent Central IRB
Official's Role
Study Chair
Facility Information:
City
Artesia
State/Province
California
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Durham
State/Province
North Carolina
Country
United States
City
Houston
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Tolerability, Safety and Efficacy of RKI983 Eye Drops in Subjects With Primary Open Angle Glaucoma and Ocular Hypertension
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