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Efficacy, Tolerability and Safety of RKI983 (0.05% & 0.10%) vs Xalatan in Patients With POAG or Ocular Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00846989
First Posted: February 19, 2009
Last Update Posted: February 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
February 18, 2009
February 19, 2009
February 13, 2013
January 2009
April 2009   (Final data collection date for primary outcome measure)
Mean reduction of the daily average intraocular pressure (IOP) . [ Time Frame: from Baseline to Day 29 ]
Same as current
Complete list of historical versions of study NCT00846989 on ClinicalTrials.gov Archive Site
  • Mean IOP reduction at each assessment time-point [ Time Frame: from Baseline to Day 8, 15, 22 and 29 ]
  • Mean reduction of the daily average IOP [ Time Frame: from Baseline to Days 8, 15 and 22 ]
  • Frequency of adverse events [ Time Frame: 4 weeks ]
Same as current
Not Provided
Not Provided
 
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.
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
  • Glaucoma
  • Ocular Hypertension
  • Drug: RKI983A
    RKI983 0.05 % twice daily
  • Drug: RKI983A
    RKI983 0.1 % twice daily
  • Drug: Latanoprost
    Latanoprost 0.005 % once a day
  • Experimental: 1
    Intervention: Drug: RKI983A
  • Experimental: 2
    Intervention: Drug: RKI983A
  • Active Comparator: 3
    Intervention: Drug: Latanoprost
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
276
April 2009
April 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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

Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00846989
CRKI983A2201
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP