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

Phase 1

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: RKI983A; Drug: Latanoprost

• Registration Number: NCT00846989
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-18
• Study First Submitted QC: 2009-02-18
• Study First Posted: 2009-02-19
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Disposition First Submitted: 2012-05-02
• Disposition First Submitted QC: 2012-05-02
• Disposition First Posted: 2012-05-04
• Status Verified: 2013-02
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 276

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	RKI983A	-
2	RKI983A	-
3	Latanoprost	-

Primary Outcome Measures

Name	Time	Method
Mean reduction of the daily average intraocular pressure (IOP) .	from Baseline to Day 29

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 Spokane, Washington, United States