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

NCT ID: NCT00846989

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

Keywords

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glaucoma, primary open-angle glaucoma (POAG), ocular hypertension (OH), intraocular pressure (IOP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Group Type EXPERIMENTAL

RKI983A

Intervention Type DRUG

RKI983 0.05 % twice daily

2

Group Type EXPERIMENTAL

RKI983A

Intervention Type DRUG

RKI983 0.1 % twice daily

3

Group Type ACTIVE_COMPARATOR

Latanoprost

Intervention Type DRUG

Latanoprost 0.005 % once a day

Interventions

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RKI983A

RKI983 0.05 % twice daily

Intervention Type DRUG

RKI983A

RKI983 0.1 % twice daily

Intervention Type DRUG

Latanoprost

Latanoprost 0.005 % once a day

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Artesia, California, United States

Site Status

Novartis Investigative Site

Inglewood, California, United States

Site Status

Novartis Investigative Site

La Jolla, California, United States

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Novartis Investigative Site

Poway, California, United States

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Novartis Investigative Site

Stockton, California, United States

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Novartis Investigative Site

Danbury, Connecticut, United States

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Novartis Investigative Site

Atlanta, Georgia, United States

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Novartis Investigative Site

Morrow, Georgia, United States

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Novartis Investigative Site

Roswell, Georgia, United States

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Novartis Investigative Site

Kaneohe, Hawaii, United States

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Novartis Investigative Site

Topeka, Kansas, United States

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Novartis Investigative Site

Louisville, Kentucky, United States

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Novartis Investigative Site

Bossier City, Louisiana, United States

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Novartis Investigative Site

Cambridge, Massachusetts, United States

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Novartis Investigative Site

Springfield, Missouri, United States

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Novartis Investigative Site

Omaha, Nebraska, United States

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Novartis Investigative Site

Las Vegas, Nevada, United States

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Novartis Investigative Site

Bethpage, New York, United States

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Novartis Investigative Site

Lynbrook, New York, United States

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Novartis Investigative Site

Rochester, New York, United States

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Novartis Investigative Site

Charlotte, North Carolina, United States

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Novartis Investigative Site

Charlotte, North Carolina, United States

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Novartis Investigative Site

Tulsa, Oklahoma, United States

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Novartis Investigative Site

Mt. Pleasant, South Carolina, United States

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Novartis Investigative Site

Memphis, Tennessee, United States

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Novartis Investigative Site

El Paso, Texas, United States

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Novartis Investigative Site

Houston, Texas, United States

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Novartis Investigative Site

San Antonio, Texas, United States

Site Status

Novartis Investigative Site

Spokane, Washington, United States

Site Status

Countries

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United States

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2938

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

Other Identifiers

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CRKI983A2201

Identifier Type: -

Identifier Source: org_study_id