24 Hour IOP Lowering Efficacy of AL-3789 | NCT00643669

Studies
24 Hour IOP Lowering Efficacy of AL-3789

NCT00643669

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Nov 29, 2012Estimated

Enrollment

25Actual

Phase

Phase 2

Conditions

Open-angle Glaucoma

Interventions

AL-3789 Sterile Suspension

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

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Apr 2008Actual

Completion Date

Not provided

First Submitted Date

Mar 24, 2008

First Submission Date that Met QC Criteria

Mar 24, 2008

First Posted Date

Mar 26, 2008Estimated

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

Nov 27, 2012

Certification/Extension First Submitted that Passed QC Review

Nov 27, 2012

Certification/Extension First Posted Date

Nov 29, 2012Estimated

Last Update Submitted Date

Nov 27, 2012

Last Update Posted Date

Nov 29, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study was to describe the intraocular pressure-lowering efficacy of AL-3789 over a 24-hour period in patients with open-angle glaucoma compared to an untreated control. Patients received one treatment of AL-3789. Twenty-eight days after treatment, IOP was measured every 4 hours, beginning at 8 AM for 24 hours.

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

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AL-3789	Experimental	AL-3789 Sterile Suspension, single depot administration of 0.8 mL in the study eye	Drug: AL-3789 Sterile Suspension
No treatment	No Intervention	Fellow eye, as randomized

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AL-3789 Sterile Suspension	Drug	Single administration by anterior juxtascleral depot	AL-3789

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Intraocular Pressure (IOP)		Day 28, Up to 24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of open-angle glaucoma and treated for at least 30 days prior to Screening Visit with a topical prostaglandin analog as monotherapy.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Pregnant, intend to become pregnant, breastfeeding.
Difference in IOP greater than 3 mm Hg between eyes at Screening Visit.
Any form of glaucoma other than open-angle glaucoma.
Other protocol-defined exclusion criteria may apply.

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
Inglewood		Inglewood	California	90301	United States

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided