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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00846989

Collaborator

(none)

276

Enrollment

Locations

Arms

Duration (Months)

9.5

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

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: RKI983A Drug: Latanoprost	Phase 1/Phase 2

Study Design

Study Type:

Interventional

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 :

Jan 1, 2009

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

Apr 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Mean reduction of the daily average intraocular pressure (IOP) . [from Baseline to Day 29]

Secondary Outcome Measures

Mean IOP reduction at each assessment time-point [from Baseline to Day 8, 15, 22 and 29]
Mean reduction of the daily average IOP [from Baseline to Days 8, 15 and 22]
Frequency of adverse events [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Artesia	California	United States	90701
2	Novartis Investigative Site	Inglewood	California	United States	90301
3	Novartis Investigative Site	La Jolla	California	United States	92037
4	Novartis Investigative Site	Poway	California	United States	92064
5	Novartis Investigative Site	Stockton	California	United States	95207
6	Novartis Investigative Site	Danbury	Connecticut	United States	06810
7	Novartis Investigative Site	Atlanta	Georgia	United States	30342
8	Novartis Investigative Site	Morrow	Georgia	United States	30260
9	Novartis Investigative Site	Roswell	Georgia	United States	30076
10	Novartis Investigative Site	Kaneohe	Hawaii	United States	96744
11	Novartis Investigative Site	Topeka	Kansas	United States	66606
12	Novartis Investigative Site	Louisville	Kentucky	United States	40217
13	Novartis Investigative Site	Bossier City	Louisiana	United States	71111
14	Novartis Investigative Site	Cambridge	Massachusetts	United States	02142
15	Novartis Investigative Site	Springfield	Missouri	United States	65804
16	Novartis Investigative Site	Omaha	Nebraska	United States	68131
17	Novartis Investigative Site	Las Vegas	Nevada	United States	89148
18	Novartis Investigative Site	Bethpage	New York	United States	11714
19	Novartis Investigative Site	Lynbrook	New York	United States	11563
20	Novartis Investigative Site	Rochester	New York	United States	14618
21	Novartis Investigative Site	Charlotte	North Carolina	United States	28204
22	Novartis Investigative Site	Charlotte	North Carolina	United States	28210
23	Novartis Investigative Site	Tulsa	Oklahoma	United States	74104
24	Novartis Investigative Site	Mount Pleasant	South Carolina	United States	29464
25	Novartis Investigative Site	Memphis	Tennessee	United States	38119
26	Novartis Investigative Site	El Paso	Texas	United States	79904
27	Novartis Investigative Site	Houston	Texas	United States	77030
28	Novartis Investigative Site	San Antonio	Texas	United States	78229
29	Novartis Investigative Site	Spokane	Washington	United States	99202