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:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00846989
First received: February 18, 2009
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Glaucoma
Ocular Hypertension
Drug: RKI983A
Drug: Latanoprost
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Mean reduction of the daily average intraocular pressure (IOP) . [ Time Frame: from Baseline to Day 29 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean IOP reduction at each assessment time-point [ Time Frame: from Baseline to Day 8, 15, 22 and 29 ] [ Designated as safety issue: No ]
  • Mean reduction of the daily average IOP [ Time Frame: from Baseline to Days 8, 15 and 22 ] [ Designated as safety issue: No ]
  • Frequency of adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 276
Study Start Date: January 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846989

  Hide Study Locations
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, 28210
Novartis Investigative Site
Charlotte, North Carolina, United States, 28204
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
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00846989     History of Changes
Other Study ID Numbers: CRKI983A2201
Study First Received: February 18, 2009
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014