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

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ClinicalTrials.gov Identifier: NCT00846989
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : February 13, 2013
Sponsor:
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: Eye Care Glaucoma
Drug Information available for: Latanoprost
U.S. FDA Resources

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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


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 ClinicalTrials.gov identifier (NCT number): NCT00846989


  Show 29 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov 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 ):
glaucoma,
primary open-angle glaucoma (POAG),
ocular hypertension (OH),
intraocular pressure (IOP)

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