Phase II Safety and Efficacy Study to Evaluate a Glaucoma... | NCT00069719

Studies
Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients

NCT00069719

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Aug 5, 2008Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Open-Angle Glaucoma
Ocular Hypertension

Interventions

Glaucoma therapy

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

ID	Type	Description	Link
C-02-33

Status Module

Record Verification Date

Aug 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

Feb 1999

Primary Completion Date

Aug 2003Actual

Completion Date

Aug 2003Actual

First Submitted Date

Sep 30, 2003

First Submission Date that Met QC Criteria

Oct 3, 2003

First Posted Date

Oct 6, 2003Estimated

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

Aug 4, 2008

Last Update Posted Date

Aug 5, 2008Estimated

Description Module

Brief Summary

To determine the safety and IOP-lowering ability of a test compound in 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

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Glaucoma therapy	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension;
logMAR visual acuity not worse than 0.6.

Exclusion Criteria:

Clinically relevant ophthalmic or systemic conditions may be excluded.

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alcon Clinical Trial Sites		Multiple Locations Throughout the US Sponsored by Alcon of	Texas		United States

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension
D005901	Glaucoma
D006973	Hypertension

Ancestor Terms

ID	Term
D005128	Eye Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided