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

Novartis

Status and phase

Completed

Phase 2

Phase 1

Conditions

Glaucoma

Ocular Hypertension

Treatments

Drug: RKI983A

Drug: Latanoprost

Study type

Interventional

Funder types

Industry

Identifiers

NCT00846989

CRKI983A2201

Details and patient eligibility

About

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.

Enrollment

276 patients

Sex

Male

Ages

18+ years old

Volunteers

No 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.