NCT00287521

Brief Summary

The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

November 1, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2006

Completed
Last Updated

March 5, 2012

Status Verified

March 1, 2012

Enrollment Period

3 months

First QC Date

February 3, 2006

Last Update Submit

March 2, 2012

Conditions

Open-angle GlaucomaOcular Hypertension

Keywords

openangleglaucomaocularhypertension

Outcome Measures

Primary Outcomes (1)

  • Mean intra-ocular pressure (IOP) change at Day 28 from baseline (Day 0)

    Day 28

Study Arms (4)

AL-37807 Suspension

EXPERIMENTAL
Drug: AL-37807 Ophthalmic Suspension, 1.0%

Xalatan

ACTIVE COMPARATOR
Drug: Latanoprost, 0.005% (Xalatan)

AL-37807 Vehicle

PLACEBO COMPARATOR
Other: AL-37807 Vehicle

Timolol Maleate

EXPERIMENTAL
Drug: Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%

Interventions

AL-37807 Ophthalmic Suspension, 1.0%DRUG

One drop in the study eye(s) once daily for 28 days

AL-37807 Suspension
Latanoprost, 0.005% (Xalatan)DRUG

One drop in the study eye(s) once daily for 28 days

Also known as: XALATAN
Xalatan
AL-37807 VehicleOTHER

One drop in the study eye(s) once daily for 28 days

AL-37807 Vehicle
Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%DRUG

One drop in the study eye(s) once daily for 28 days

Timolol Maleate

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with open-angle glaucoma (with ot without pseudoexfoliation or pigment dispersion component) or ocular hypertension

You may not qualify if:

  • Under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United States Investigative Sites in Texas and Other States

Fort Worth, Texas, 76180, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular HypertensionGlaucomaHypertension

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Eye DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

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

Study Record Dates

First Submitted

February 3, 2006

First Posted

February 7, 2006

Study Start

November 1, 2005

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

March 5, 2012

Record last verified: 2012-03

Locations

US(1)