AL-54478 Proof of Concept Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01318252
First received: March 16, 2011
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01318252

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01318252     History of Changes
Other Study ID Numbers: C-10-080
Study First Received: March 16, 2011
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
Elevated IOP

Additional relevant MeSH terms:
Hypertension
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Glaucoma
Eye Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014