NCT00069706

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2003

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2003

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2003

Completed
Last Updated

February 14, 2012

Status Verified

February 1, 2012

Enrollment Period

3 months

First QC Date

September 30, 2003

Last Update Submit

February 11, 2012

Conditions

Open-angle GlaucomaOcular Hypertension

Keywords

open-angleglaucomaocularhypertensionPOAG

Outcome Measures

Primary Outcomes (1)

  • Mean Intraocular Pressure (IOP)

Study Arms (5)

AL-12182 0.003%

EXPERIMENTAL

One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days

Drug: AL-12182 0.003% Ophthalmic Solution

AL-12182 Solution Vehicle

PLACEBO COMPARATOR

One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days

Other: AL-12182 Ophthalmic Solution Vehicle

Latanoprost

ACTIVE COMPARATOR

One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days

Drug: Latanoprost 0.005% Ophthalmic Solution

AL-12182 0.01%

EXPERIMENTAL

One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days

Drug: AL-12182 0.01% Ophthalmic Solution

AL-12182 0.03%

EXPERIMENTAL

One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days

Drug: AL-12182 0.03% Ophthalmic Solution

Interventions

AL-12182 0.003% Ophthalmic SolutionDRUG

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

AL-12182 0.003%
AL-12182 Ophthalmic Solution VehicleOTHER

Placebo

AL-12182 Solution Vehicle
Latanoprost 0.005% Ophthalmic SolutionDRUG

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

Latanoprost
AL-12182 0.01% Ophthalmic SolutionDRUG

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

AL-12182 0.01%
AL-12182 0.03% Ophthalmic SolutionDRUG

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

AL-12182 0.03%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older.
  • Diagnosis of open-angle glaucoma or ocular hypertension.
  • LogMAR visual acuity not worse than 0.6.

You may not qualify if:

  • Clinically relevant ophthalmic or systemic conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular HypertensionGlaucomaHypertension

Interventions

AL-12182Ophthalmic SolutionsLatanoprost

Condition Hierarchy (Ancestors)

Eye DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of ChemicalsProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2003

First Posted

October 6, 2003

Study Start

July 1, 2003

Primary Completion

October 1, 2003

Study Completion

October 1, 2003

Last Updated

February 14, 2012

Record last verified: 2012-02