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AL-54478 Proof of Concept Study

This study has been completed.
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: March 16, 2011
Last updated: July 28, 2014
Last verified: July 2014
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.

Condition Intervention Phase
Open-angle Glaucoma (OAG)
Ocular Hypertension (OHT)
Drug: AL-54478 0.005%
Drug: Latanoprost 0.005%
Drug: AL-54478 Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 24-hour Area Under the Curve (AUC) for IOP Change from Baseline after 14 Days of Once Daily Dosing [ Time Frame: Day 14 ]

Enrollment: 64
Study Start Date: June 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL-54478
AL-54478 0.005%, single dose, followed 7 days later with 14 days of once daily dosing
Drug: AL-54478 0.005%
Active Comparator: Latanoprost
Latanoprost 0.005%, single dose, followed 7 days later with 14 days of once daily dosing
Drug: Latanoprost 0.005%
Placebo Comparator: Vehicle
AL-54478 Vehicle, single dose, followed 7 days later with 14 days of once daily dosing
Drug: AL-54478 Vehicle
Inactive ingredients used as a placebo comparator


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01318252

Sponsors and Collaborators
Alcon Research
Study Director: Ravaughn Williams Alcon Research
  More Information

Responsible Party: Alcon Research Identifier: NCT01318252     History of Changes
Other Study ID Numbers: C-10-080
Study First Received: March 16, 2011
Last Updated: July 28, 2014

Keywords provided by Alcon Research:
Elevated IOP

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Antihypertensive Agents processed this record on April 28, 2017