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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RKI983A | Drug | RKI983 0.05 % twice daily |
| |
| RKI983A |
| Measure | Description | Time Frame |
|---|---|---|
| Mean reduction of the daily average intraocular pressure (IOP) . | from Baseline to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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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
Or for study eyes previously treated with anti-glaucoma medications
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Artesia | California | 90701 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CRKI983A2201 can be found on the Novartis Clinical Trial Results website. | View source |
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| Drug |
RKI983 0.1 % twice daily |
|
| Latanoprost | Drug | Latanoprost 0.005 % once a day |
|
| Frequency of adverse events |
| 4 weeks |
| Inglewood |
| California |
| 90301 |
| United States |
| Novartis Investigative Site | La Jolla | California | 92037 | United States |
| Novartis Investigative Site | Poway | California | 92064 | United States |
| Novartis Investigative Site | Stockton | California | 95207 | United States |
| Novartis Investigative Site | Danbury | Connecticut | 06810 | United States |
| Novartis Investigative Site | Atlanta | Georgia | 30342 | United States |
| Novartis Investigative Site | Morrow | Georgia | 30260 | United States |
| Novartis Investigative Site | Roswell | Georgia | 30076 | United States |
| Novartis Investigative Site | Kaneohe | Hawaii | 96744 | United States |
| Novartis Investigative Site | Topeka | Kansas | 66606 | United States |
| Novartis Investigative Site | Louisville | Kentucky | 40217 | United States |
| Novartis Investigative Site | Bossier City | Louisiana | 71111 | United States |
| Novartis Investigative Site | Cambridge | Massachusetts | 02142 | United States |
| Novartis Investigative Site | Springfield | Missouri | 65804 | United States |
| Novartis Investigative Site | Omaha | Nebraska | 68131 | United States |
| Novartis Investigative Site | Las Vegas | Nevada | 89148 | United States |
| Novartis Investigative Site | Bethpage | New York | 11714 | United States |
| Novartis Investigative Site | Lynbrook | New York | 11563 | United States |
| Novartis Investigative Site | Rochester | New York | 14618 | United States |
| Novartis Investigative Site | Charlotte | North Carolina | 28204 | United States |
| Novartis Investigative Site | Charlotte | North Carolina | 28210 | United States |
| Novartis Investigative Site | Tulsa | Oklahoma | 74104 | United States |
| Novartis Investigative Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Novartis Investigative Site | Memphis | Tennessee | 38119 | United States |
| Novartis Investigative Site | El Paso | Texas | 79904 | United States |
| Novartis Investigative Site | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | San Antonio | Texas | 78229 | United States |
| Novartis Investigative Site | Spokane | Washington | 99202 | United States |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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