Tolerability, Safety and Efficacy of RKI983 Eye Drops in Subjects With Primary Open Angle Glaucoma and Ocular Hypertension
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
1 other identifier
interventional
90
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 9, 2007
CompletedFirst Posted
Study publicly available on registry
August 13, 2007
CompletedDecember 28, 2007
December 1, 2007
August 9, 2007
December 19, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change in ocular hypertension from Baseline to Day 7.
Interventions
Eligibility Criteria
You may qualify if:
- Males and females, ≥18 years of age, with primary open angle glaucoma and ocular hypertension
- Females must be post-menopausal or surgically sterile
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (5)
Unknown Facility
Artesia, California, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Durham, North Carolina, United States
Unknown Facility
Houston, Texas, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis
Independent Central IRB
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 9, 2007
First Posted
August 13, 2007
Study Start
July 1, 2007
Last Updated
December 28, 2007
Record last verified: 2007-12