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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma
• Intervention / Treatment: Drug: RKI983A; Drug: RKI983A; Drug: Latanoprost

• Study Type: Interventional
• Enrollment (Actual): 276
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • 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
      • Novartis Investigative Site
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Novartis Investigative Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Novartis Investigative Site
    • Morrow, Georgia, United States, 30260
      • Novartis Investigative Site
    • Roswell, Georgia, United States, 30076
      • Novartis Investigative Site
  • Hawaii
    • Kaneohe, Hawaii, United States, 96744
      • Novartis Investigative Site
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Novartis Investigative Site
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Novartis Investigative Site
  • Louisiana
    • Bossier City, Louisiana, United States, 71111
      • Novartis Investigative Site
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02142
      • Novartis Investigative Site
  • Missouri
    • Springfield, Missouri, United States, 65804
      • Novartis Investigative Site
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Novartis Investigative Site
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Novartis Investigative Site
  • New York
    • Bethpage, New York, United States, 11714
      • Novartis Investigative Site
    • Lynbrook, New York, United States, 11563
      • Novartis Investigative Site
    • Rochester, New York, United States, 14618
      • Novartis Investigative Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Novartis Investigative Site
    • Charlotte, North Carolina, United States, 28210
      • Novartis Investigative Site
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Novartis Investigative Site
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Novartis Investigative Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Novartis Investigative Site
  • Texas
    • El Paso, Texas, United States, 79904
      • Novartis Investigative Site
    • Houston, Texas, United States, 77030
      • Novartis Investigative Site
    • San Antonio, Texas, United States, 78229
      • Novartis Investigative Site
  • Washington
    • Spokane, Washington, United States, 99202
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: RKI983A; RKI983 0.05 % twice daily; Drug: RKI983A; RKI983 0.1 % twice daily
Experimental: 2	Drug: RKI983A; RKI983 0.05 % twice daily; Drug: RKI983A; RKI983 0.1 % twice daily
Active Comparator: 3	Drug: Latanoprost; Latanoprost 0.005 % once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean reduction of the daily average intraocular pressure (IOP) .	from Baseline to Day 29

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CRKI983A2201 can be found on the Novartis Clinical Trial Results website.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: February 18, 2009
• First Submitted That Met QC Criteria: February 18, 2009
• First Posted (Estimate): February 19, 2009

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: glaucoma,; primary open-angle glaucoma (POAG),; ocular hypertension (OH),; intraocular pressure (IOP)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Ocular Hypertension; Hypertension; Pharmaceutical Solutions; Ophthalmic Solutions; Latanoprost
• Other Study ID Numbers: CRKI983A2201