AL-54478 Proof of Concept Study

NCT01318252•Alcon Research

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

Key Dates

Start Date

June 1, 2011

Primary Completion Date

October 1, 2011

Completion Date

October 1, 2011

Last Updated

July 31, 2014

Enrollment

ACTUAL participants

Conditions

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

Interventions

AL-54478 0.005%

DRUG

Latanoprost 0.005%

DRUG

AL-54478 Vehicle

DRUG

Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma and Ocular Hypertension

NCT02226094

Primary Open-angle Glaucoma (POAG)Ocular Hypertension (OHT)

View study

COMPLETEDPHASE1

Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle Glaucoma

NCT01670266

Ocular Hypertension (OHT)Mild Open Angle-glaucoma (OAG)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 31, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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AL-54478 Proof of Concept Study

Inclusion Criteria

Exclusion Criteria

Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma and Ocular Hypertension

Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle Glaucoma

Travoprost Five Day Posology Study