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

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. Identifier: NCT00846989
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : February 13, 2013
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: RKI983A Drug: Latanoprost Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : January 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost

Arm Intervention/treatment
Experimental: 1 Drug: RKI983A
RKI983 0.05 % twice daily

Experimental: 2 Drug: RKI983A
RKI983 0.1 % twice daily

Active Comparator: 3 Drug: Latanoprost
Latanoprost 0.005 % once a day

Primary Outcome Measures :
  1. Mean reduction of the daily average intraocular pressure (IOP) . [ Time Frame: from Baseline to Day 29 ]

Secondary Outcome Measures :
  1. Mean IOP reduction at each assessment time-point [ Time Frame: from Baseline to Day 8, 15, 22 and 29 ]
  2. Mean reduction of the daily average IOP [ Time Frame: from Baseline to Days 8, 15 and 22 ]
  3. Frequency of adverse events [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00846989

  Hide Study Locations
United States, California
Novartis Investigative Site
Artesia, California, United States, 90701
Novartis Investigative Site
Inglewood, California, United States, 90301
Novartis Investigative Site
La Jolla, California, United States, 92037
Novartis Investigative Site
Poway, California, United States, 92064
Novartis Investigative Site
Stockton, California, United States, 95207
United States, Connecticut
Novartis Investigative Site
Danbury, Connecticut, United States, 06810
United States, Georgia
Novartis Investigative Site
Atlanta, Georgia, United States, 30342
Novartis Investigative Site
Morrow, Georgia, United States, 30260
Novartis Investigative Site
Roswell, Georgia, United States, 30076
United States, Hawaii
Novartis Investigative Site
Kaneohe, Hawaii, United States, 96744
United States, Kansas
Novartis Investigative Site
Topeka, Kansas, United States, 66606
United States, Kentucky
Novartis Investigative Site
Louisville, Kentucky, United States, 40217
United States, Louisiana
Novartis Investigative Site
Bossier City, Louisiana, United States, 71111
United States, Massachusetts
Novartis Investigative Site
Cambridge, Massachusetts, United States, 02142
United States, Missouri
Novartis Investigative Site
Springfield, Missouri, United States, 65804
United States, Nebraska
Novartis Investigative Site
Omaha, Nebraska, United States, 68131
United States, Nevada
Novartis Investigative Site
Las Vegas, Nevada, United States, 89148
United States, New York
Novartis Investigative Site
Bethpage, New York, United States, 11714
Novartis Investigative Site
Lynbrook, New York, United States, 11563
Novartis Investigative Site
Rochester, New York, United States, 14618
United States, North Carolina
Novartis Investigative Site
Charlotte, North Carolina, United States, 28204
Novartis Investigative Site
Charlotte, North Carolina, United States, 28210
United States, Oklahoma
Novartis Investigative Site
Tulsa, Oklahoma, United States, 74104
United States, South Carolina
Novartis Investigative Site
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
Novartis Investigative Site
Memphis, Tennessee, United States, 38119
United States, Texas
Novartis Investigative Site
El Paso, Texas, United States, 79904
Novartis Investigative Site
Houston, Texas, United States, 77030
Novartis Investigative Site
San Antonio, Texas, United States, 78229
United States, Washington
Novartis Investigative Site
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00846989     History of Changes
Other Study ID Numbers: CRKI983A2201
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: February 13, 2013
Last Verified: February 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
primary open-angle glaucoma (POAG),
ocular hypertension (OH),
intraocular pressure (IOP)

Additional relevant MeSH terms:
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Antihypertensive Agents