Status:
COMPLETED
Efficacy, Tolerability and Safety of RKI983 (0.05% & 0.10%) vs Xalatan in Patients With POAG or Ocular Hypertension
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Glaucoma
Ocular Hypertension
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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;
- active severe viral infections such as active encephalitis, meningitis, hepatitis, herpes simplex, or herpes zoster (minor viral upper respiratory infections such as colds do not require exclusion.)
- 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.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT00846989
Start Date
January 1 2009
End Date
April 1 2009
Last Update
December 19 2020
Active Locations (29)
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1
Novartis Investigative Site
Artesia, California, United States, 90701
2
Novartis Investigative Site
Inglewood, California, United States, 90301
3
Novartis Investigative Site
La Jolla, California, United States, 92037
4
Novartis Investigative Site
Poway, California, United States, 92064