Clinical trial NCT00846989: Efficacy, Tolerability and Safety of RKI983 (0.05% & 0.10%) vs Xalatan in Patients With POAG or Ocular Hypertension
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glaucoma
Ocular Hypertension
Keywords: glaucoma,
primary open-angle glaucoma (POAG),
ocular hypertension (OH),
intraocular pressure (IOP)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 276
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Mean reduction of the daily average intraocular pressure (IOP) .
timeFrame: from Baseline to Day 29
Secondary outcomes:
measure: Mean IOP reduction at each assessment time-point
timeFrame: from Baseline to Day 8, 15, 22 and 29
measure: Mean reduction of the daily average IOP
timeFrame: from Baseline to Days 8, 15 and 22
measure: Frequency of adverse events
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Novartis Investigative Site
state: California
city: Inglewood
country: United States
facility: Novartis Investigative Site
state: California
city: La Jolla
country: United States
facility: Novartis Investigative Site
state: California
city: Poway
country: United States
facility: Novartis Investigative Site
state: California
city: Stockton
country: United States
facility: Novartis Investigative Site
state: California
city: Danbury
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Morrow
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Roswell
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Kaneohe
country: United States
facility: Novartis Investigative Site
state: Hawaii
city: Topeka
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Louisville
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Bossier City
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Cambridge
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Springfield
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Las Vegas
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Bethpage
country: United States
facility: Novartis Investigative Site
state: New York
city: Lynbrook
country: United States
facility: Novartis Investigative Site
state: New York
city: Rochester
country: United States
facility: Novartis Investigative Site
state: New York
city: Charlotte
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Charlotte
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Tulsa
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Mount Pleasant
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Memphis
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: El Paso
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: Spokane
country: United States
facility: Novartis Investigative Site
state: Washington
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: