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

Glaucoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00846989
• Other study ID #: CRKI983A2201
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2009
• Est. completion date: April 2009

Study information

• Verified date: February 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• RKI983A
RKI983 0.05 % twice daily
• RKI983A
RKI983 0.1 % twice daily
• Latanoprost
Latanoprost 0.005 % once a day

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Artesia	California
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Bethpage	New York
United States	Novartis Investigative Site	Bossier City	Louisiana
United States	Novartis Investigative Site	Cambridge	Massachusetts
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Danbury	Connecticut
United States	Novartis Investigative Site	El Paso	Texas
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Inglewood	California
United States	Novartis Investigative Site	Kaneohe	Hawaii
United States	Novartis Investigative Site	La Jolla	California
United States	Novartis Investigative Site	Las Vegas	Nevada
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	Lynbrook	New York
United States	Novartis Investigative Site	Memphis	Tennessee
United States	Novartis Investigative Site	Morrow	Georgia
United States	Novartis Investigative Site	Mount Pleasant	South Carolina
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Poway	California
United States	Novartis Investigative Site	Rochester	New York
United States	Novartis Investigative Site	Roswell	Georgia
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	Spokane	Washington
United States	Novartis Investigative Site	Springfield	Missouri
United States	Novartis Investigative Site	Stockton	California
United States	Novartis Investigative Site	Topeka	Kansas
United States	Novartis Investigative Site	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean reduction of the daily average intraocular pressure (IOP) .		from Baseline to Day 29
Secondary	Mean IOP reduction at each assessment time-point		from Baseline to Day 8, 15, 22 and 29
Secondary	Mean reduction of the daily average IOP		from Baseline to Days 8, 15 and 22
Secondary	Frequency of adverse events		4 weeks

External Links

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