AL-54478 Proof of Concept Study | NCT01318252

Studies
AL-54478 Proof of Concept Study

NCT01318252

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Jul 31, 2014Estimated

Enrollment

64Actual

Phase

Phase 2

Conditions

Open-angle Glaucoma (OAG)
Ocular Hypertension (OHT)

Interventions

AL-54478 0.005%
Latanoprost 0.005%
AL-54478 Vehicle

Countries

Not provided

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

Jul 2014

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

Jun 2011

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Mar 16, 2011

First Submission Date that Met QC Criteria

Mar 16, 2011

First Posted Date

Mar 18, 2011Estimated

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

Jul 28, 2014

Certification/Extension First Submitted that Passed QC Review

Jul 28, 2014

Certification/Extension First Posted Date

Jul 31, 2014Estimated

Last Update Submitted Date

Jul 28, 2014

Last Update Posted Date

Jul 31, 2014Estimated

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

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

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AL-54478	Experimental	AL-54478 0.005%, single dose, followed 7 days later with 14 days of once daily dosing	Drug: AL-54478 0.005%
Latanoprost	Active Comparator	Latanoprost 0.005%, single dose, followed 7 days later with 14 days of once daily dosing	Drug: Latanoprost 0.005%
Vehicle	Placebo Comparator	AL-54478 Vehicle, single dose, followed 7 days later with 14 days of once daily dosing	Drug: AL-54478 Vehicle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AL-54478 0.005%	Drug		AL-54478
Latanoprost 0.005%

Measure	Description	Time Frame
24-hour Area Under the Curve (AUC) for IOP Change from Baseline after 14 Days of Once Daily Dosing		Day 14

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with either OAG or OHT.
Patients who are able to comply with the scheduled visits.
Patients who have had a physical exam within 6 months of the Screening Visit.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Females of childbearing potential who meet any 1 of the following conditions: a) Currently pregnant; b) Positive urine pregnancy test; c)Intend to become pregnant; d) Breast feeding; e) Not using highly effective birth control measures.
Patients with extreme narrow angle with complete or partial closure.
Patients with a cup to disc ratio more than 0.8.
Patients with a severe central visual field loss in either eye.
Patients with chronic or recurrent inflammatory eye disease or acute ocular infection or inflammation.
Patients who have had ocular trauma within the past 6 months or have had intraocular surgery within the past 6 months or have had ocular laser surgery within the past 3 months.
Patients with best-correct visual acuity less than 20/80.
Patients who have had ocular infection or inflammation within the past 3 months.
Patients who have clinically relevant progressive retinal disease.
Patients who have severe illness or conditions.
Patients who have hypersensitivity to a prostaglandin analogu.e
Patients who are unable to safely discontinue all IOP-lowering medications during washout.
Patients who are currently on therapy with another investigational agent within 30 days prior to the Screening Visit.
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

ID	Term
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension

ID	Term
D005901	Glaucoma
D005128	Eye Diseases