Efficacy, Tolerability and Safety of RKI983 (0.05% & 0.10%) vs Xalatan in Patients With POAG or Ocular Hypertension
A 4-week Multi-center, Single-masked, Randomized, Latanoprost-controlled, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of RKI983 (0.05% and 0.10%) Ophthalmic Solution Given Twice a Day Versus Once Daily Latanoprost 0.005%, in Patients With Primary Open Angle Glaucoma or Ocular Hypertension.
1 other identifier
interventional
276
1 country
29
Brief Summary
This purpose of this study is to access the efficacy, tolerability and safety of RKI983 (0.05% and 0.10%) ophthalmic solution bid versus once daily latanoprost 0.005%, in patients with POAG or 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
Started Jan 2009
Shorter than P25 for phase_1
29 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
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 18, 2009
CompletedFirst Posted
Study publicly available on registry
February 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedDecember 19, 2020
February 1, 2013
3 months
February 18, 2009
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean reduction of the daily average intraocular pressure (IOP) .
from Baseline to Day 29
Secondary Outcomes (3)
Mean IOP reduction at each assessment time-point
from Baseline to Day 8, 15, 22 and 29
Mean reduction of the daily average IOP
from Baseline to Days 8, 15 and 22
Frequency of adverse events
4 weeks
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Females must be post-menopausal or surgically sterile, or must use concomitantly two acceptable forms of effective contraception
- Clinical diagnosis of POAG or OH
- For study eyes not previously treated with anti-glaucoma medications
- IOP must be ≥ 22 mm Hg at least at two assessment time-points at Screening, and
- IOP must be ≥ 22 mm Hg at least at two assessment time-points at Baseline, and
- IOP must be ≥ 20 mm Hg and ≤ 36 mm Hg at all Screening and Baseline assessment time-points.
- Or for study eyes previously treated with anti-glaucoma medications
- IOP must be ≥ 14 mm Hg and ≤ 24 mm Hg at least at two assessment time-points at Screening.
- IOP must be ≥ 22 mm Hg at least at two assessment time-points at Baseline (after wash-out)
- IOP must be ≥ 20 mm Hg and ≤ 36 mm Hg at all Baseline assessment time-points
You may not qualify if:
- History of or current clinically significant ocular conditions in either eye that would contraindicate the use of an investigational drug or latanoprost (e.g. active intraocular inflammation), or that might affect interpretation of the results of the study.
- History or presence of clinically significant medical problems that contraindicate the use of an investigational drug or latanoprost, including but not limited to:
- Uncontrolled hypertension with systolic blood pressure ≥ 160 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg measured at more than one blood pressure reading at Screening or Baseline;
- myocardial infarction within the 3 months period prior to randomization;
- Presence of moderate or severe (grade 2 or 3) conjunctival hyperemia in the study eye at Baseline Visit.
- Argon laser trabeculoplasty or any prior IOP lowering surgery in the study eye.
- Ocular surgery in the study eye within 3 months prior to the Screening Visit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Novartis Investigative Site
Artesia, California, 90701, United States
Novartis Investigative Site
Inglewood, California, 90301, United States
Novartis Investigative Site
La Jolla, California, 92037, United States
Novartis Investigative Site
Poway, California, 92064, United States
Novartis Investigative Site
Stockton, California, 95207, United States
Novartis Investigative Site
Danbury, Connecticut, 06810, United States
Novartis Investigative Site
Atlanta, Georgia, 30342, United States
Novartis Investigative Site
Morrow, Georgia, 30260, United States
Novartis Investigative Site
Roswell, Georgia, 30076, United States
Novartis Investigative Site
Kaneohe, Hawaii, 96744, United States
Novartis Investigative Site
Topeka, Kansas, 66606, United States
Novartis Investigative Site
Louisville, Kentucky, 40217, United States
Novartis Investigative Site
Bossier City, Louisiana, 71111, United States
Novartis Investigative Site
Cambridge, Massachusetts, 02142, United States
Novartis Investigative Site
Springfield, Missouri, 65804, United States
Novartis Investigative Site
Omaha, Nebraska, 68131, United States
Novartis Investigative Site
Las Vegas, Nevada, 89148, United States
Novartis Investigative Site
Bethpage, New York, 11714, United States
Novartis Investigative Site
Lynbrook, New York, 11563, United States
Novartis Investigative Site
Rochester, New York, 14618, United States
Novartis Investigative Site
Charlotte, North Carolina, 28204, United States
Novartis Investigative Site
Charlotte, North Carolina, 28210, United States
Novartis Investigative Site
Tulsa, Oklahoma, 74104, United States
Novartis Investigative Site
Mt. Pleasant, South Carolina, 29464, United States
Novartis Investigative Site
Memphis, Tennessee, 38119, United States
Novartis Investigative Site
El Paso, Texas, 79904, United States
Novartis Investigative Site
Houston, Texas, 77030, United States
Novartis Investigative Site
San Antonio, Texas, 78229, United States
Novartis Investigative Site
Spokane, Washington, 99202, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2009
First Posted
February 19, 2009
Study Start
January 1, 2009
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
December 19, 2020
Record last verified: 2013-02