A Phase II Study of AL-37807 to Treat Open-Angle Glaucoma... | NCT00372931

Studies
A Phase II Study of AL-37807 to Treat Open-Angle Glaucoma or Ocular Hypertension

NCT00372931

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Apr 22, 2008Estimated

Enrollment

120

Phase

Phase 2

Conditions

Open-Angle Glaucoma
Ocular Hypertension

Interventions

AL-37807

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

May 2006

Primary Completion Date

Aug 2007Actual

Completion Date

Not provided

First Submitted Date

Sep 6, 2006

First Submission Date that Met QC Criteria

Sep 6, 2006

First Posted Date

Sep 7, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2008

Last Update Posted Date

Apr 22, 2008Estimated

Description Module

Brief Summary

The purpose of this study is to determine whether AL-37807 is safe and effective in treating patients with open-angle glaucoma or ocular hypertension

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120

Name	Type	Description	Arm Group Labels	Other Names
AL-37807	Drug

Measure	Description	Time Frame
Mean IOP change from baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients of either sex and any race with open-angle glaucoma or ocular hypertension; logMAR visual acuity not worse than 0.60; additionally clinically relevant ophthalmic or systemic conditions may be excluded

Exclusion Criteria:

Under 18

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Theresa Landry	Study Director	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Antonio Site		San Antonio	Texas	78240	United States

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension

Ancestor Terms

ID	Term
D005901	Glaucoma
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided