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AL-54478 Proof of Concept Study

NCT ID: NCT01318252

Last Updated: 2014-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-10-31

Brief Summary

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The purpose of this study is to assess the safety and efficacy of AL-54478 0.005% compared with Latanoprost 0.005% and AL-54478 Vehicle in patients with open-angle glaucoma or ocular hypertension.

Detailed Description

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Conditions

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

Keywords

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Elevated IOP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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AL-54478

AL-54478 0.005%, single dose, followed 7 days later with 14 days of once daily dosing

Group Type EXPERIMENTAL

AL-54478 0.005%

Intervention Type DRUG

Latanoprost

Latanoprost 0.005%, single dose, followed 7 days later with 14 days of once daily dosing

Group Type ACTIVE_COMPARATOR

Latanoprost 0.005%

Intervention Type DRUG

Vehicle

AL-54478 Vehicle, single dose, followed 7 days later with 14 days of once daily dosing

Group Type PLACEBO_COMPARATOR

AL-54478 Vehicle

Intervention Type DRUG

Inactive ingredients used as a placebo comparator

Interventions

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AL-54478 0.005%

Intervention Type DRUG

Latanoprost 0.005%

Intervention Type DRUG

AL-54478 Vehicle

Inactive ingredients used as a placebo comparator

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ravaughn Williams

Role: STUDY_DIRECTOR

Alcon Research

Countries

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United States

Other Identifiers

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C-10-080

Identifier Type: -

Identifier Source: org_study_id