Tolerability, Safety and Efficacy of RKI983 Eye Drops in Subjects With Primary Open Angle Glaucoma and Ocular Hypertension

A Multicenter, Randomized, Placebo-Controlled, Latanoprost-Controlled, Parallel Group Study to Assess the Tolerability, Safety and Efficacy of RKI983 Ophthalmic Solution Given Twice a Day Over One Week in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00515424

Enrollment

Registered

2007-08-13

Start date

2007-07-31

Completion date

Unknown

Last updated

2007-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Ocular Hypertension

Keywords

Glaucoma, Ocular Hypertension, RKI983, Primary Open Angle Glaucoma and Ocular Hypertension

Brief summary

This study will evaluate the tolerability and safety of RKI983 ophthalmic solution and explore the effect of the compound on intraocular pressure in subjects with ocular hypertension.

Interventions

DRUGRKI983

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* Males and females, ≥18 years of age, with primary open angle glaucoma and ocular hypertension * Females must be post-menopausal or surgically sterile

Exclusion criteria

* Other types of glaucoma * Eye pressure lowering surgeries * A history of or current eye conditions or medical problems that would prohibit the use of an investigational drug Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, ECGs and vital signs over period of 7 days treatment.	—

Secondary

Measure	Time frame
Change in ocular hypertension from Baseline to Day 7.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026