NCT00761709

Brief Summary

The purpose of this study is to evaluate the safety and intraocular pressure (IOP)-lowering efficacy of AL-39256 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
104

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2009

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2008

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

July 15, 2014

Status Verified

July 1, 2014

Enrollment Period

3 months

First QC Date

September 25, 2008

Last Update Submit

July 11, 2014

Conditions

Open-Angle GlaucomaOcular Hypertension

Keywords

Open Angle GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Mean change from baseline in IOP

    Week 4

Study Arms (3)

AL-39256

EXPERIMENTAL

AL-39256 Ophthalmic Suspension, 1%, 1 drop in the study eye(s) at 8 AM from the morning bottle and 1 drop in the study eye(s) at 8 PM from the evening bottle for 4 weeks.

Drug: AL-39256 Ophthalmic Suspension, 1%

XALATAN

ACTIVE COMPARATOR

Latanoprost Ophthalmic Solution, 0.005%, 1 drop in the study eye(s) at 8 PM from the evening bottle (morning bottle contained vehicle and was dosed 1 drop in the study eye(s) at 8 AM) for 4 weeks.

Drug: Latanoprost Ophthalmic Solution, 0.005%Drug: Vehicle

Vehicle

PLACEBO COMPARATOR

Inactive ingredients, 1 drop in the study eye(s) at 8 AM from the morning bottle and 1 drop in the study eye(s) at 8 PM from the evening bottle for 4 weeks.

Drug: Vehicle

Interventions

AL-39256 Ophthalmic Suspension, 1%DRUG
AL-39256
Latanoprost Ophthalmic Solution, 0.005%DRUG
Also known as: XALATAN®
XALATAN
VehicleDRUG

Inactive ingredients used as a placebo comparator

VehicleXALATAN

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with open-angle glaucoma or ocular hypertension.

You may not qualify if:

  • Females of childbearing potential.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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, Ph.D.

    Alcon Research

    STUDY DIRECTOR

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 25, 2008

First Posted

September 29, 2008

Study Start

July 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

July 15, 2014

Record last verified: 2014-07