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Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-angle Glaucoma or Ocular Hypertension Patients

Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-angle Glaucoma or Ocular Hypertension Patients

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00069706
Enrollment
118
Registered
2003-10-06
Start date
2003-07-31
Completion date
2003-10-31
Last updated
2012-02-14

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

Conditions

Open-angle Glaucoma, Ocular Hypertension

Keywords

open-angle, glaucoma, ocular, hypertension, POAG

Brief summary

The purpose of this study is to determine the safety and IOP-lowering ability of a glaucoma therapy in patients with open-angle glaucoma or ocular hypertension.

Interventions

DRUGAL-12182 0.003% Ophthalmic Solution

Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

OTHERAL-12182 Ophthalmic Solution Vehicle

Placebo

DRUGLatanoprost 0.005% Ophthalmic Solution

Commercially marketed ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

DRUGAL-12182 0.01% Ophthalmic Solution

Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

DRUGAL-12182 0.03% Ophthalmic Solution

Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

Sponsors

Alcon Research
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years or older. * Diagnosis of open-angle glaucoma or ocular hypertension. * LogMAR visual acuity not worse than 0.6. * Other protocol-defined inclusion criteria may apply.

Exclusion criteria

* Clinically relevant ophthalmic or systemic conditions. * Other protocol-defined

Design outcomes

Primary

MeasureTime frame
Mean Intraocular Pressure (IOP)—

Outcome results

None listed

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