NCT00465621

Brief Summary

The purpose of thie study is to compare the safety and IOP-lowering efficacy of AL-37807 Ophthalmic Solution 0.05%, 0.1% and 0.2% dosed QD AM to Xalatan dosed QD PM and Vehicle in patients with open-angle glaucoma or ocular hypertension

Trial Health

80
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ 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

March 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Last Updated

July 29, 2008

Status Verified

July 1, 2008

Enrollment Period

4 months

First QC Date

April 23, 2007

Last Update Submit

July 28, 2008

Conditions

Open-Angle GlaucomaOcular Hypertension

Keywords

Open-angle glaucomaocular hypertension

Outcome Measures

Primary Outcomes (1)

  • Mean IP Change from Baseline

Interventions

XalatanDRUG

Eligibility Criteria

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

You may qualify if:

  • Open-angle glaucoma
  • ocular hypertension

You may not qualify if:

  • \- VA worse than 0.60

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Theresa Landry

    Alcon Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 23, 2007

First Posted

April 25, 2007

Study Start

March 1, 2007

Primary Completion

July 1, 2007

Last Updated

July 29, 2008

Record last verified: 2008-07

Locations

US(1)