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

Study Overview
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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.

Official Title
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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.

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: RKI983A
* Drug: RKI983A
* Drug: Latanoprost


Participation Criteria
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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. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: RKI983A<br>* RKI983 0.05 % twice daily<br>|
| Experimental: 2<br> | Drug: RKI983A<br>* RKI983 0.1 % twice daily<br>|
| Active Comparator: 3<br> | Drug: Latanoprost<br>* Latanoprost 0.005 % once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean reduction of the daily average intraocular pressure (IOP) . |  | from Baseline to Day 29 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Frequency of adverse events |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma,, primary open-angle glaucoma (POAG),, ocular hypertension (OH),, intraocular pressure (IOP)