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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:
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
History of Changes
  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:

Drug Information available for: Latanoprost
U.S. FDA Resources

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

  Show 29 Study Locations
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 May 16, 2013