Back to resultsAL-54478 Proof of Concept Study
Primary Purpose
Open-angle Glaucoma (OAG), Ocular Hypertension (OHT)
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AL-54478 0.005%
Latanoprost 0.005%
AL-54478 Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Open-angle Glaucoma (OAG) focused on measuring Elevated IOP
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
AL-54478
Latanoprost
Vehicle
Arm Description
AL-54478 0.005%, single dose, followed 7 days later with 14 days of once daily dosing
Latanoprost 0.005%, single dose, followed 7 days later with 14 days of once daily dosing
AL-54478 Vehicle, single dose, followed 7 days later with 14 days of once daily dosing
Outcomes
Primary Outcome Measures
24-hour Area Under the Curve (AUC) for IOP Change from Baseline after 14 Days of Once Daily Dosing
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01318252
Brief Title
AL-54478 Proof of Concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma (OAG), Ocular Hypertension (OHT)
Keywords
Elevated IOP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AL-54478
Arm Type
Experimental
Arm Description
AL-54478 0.005%, single dose, followed 7 days later with 14 days of once daily dosing
Arm Title
Latanoprost
Arm Type
Active Comparator
Arm Description
Latanoprost 0.005%, single dose, followed 7 days later with 14 days of once daily dosing
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
AL-54478 Vehicle, single dose, followed 7 days later with 14 days of once daily dosing
Intervention Type
Drug
Intervention Name(s)
AL-54478 0.005%
Intervention Type
Drug
Intervention Name(s)
Latanoprost 0.005%
Intervention Type
Drug
Intervention Name(s)
AL-54478 Vehicle
Intervention Description
Inactive ingredients used as a placebo comparator
Primary Outcome Measure Information:
Title
24-hour Area Under the Curve (AUC) for IOP Change from Baseline after 14 Days of Once Daily Dosing
Time Frame
Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravaughn Williams
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
AL-54478 Proof of Concept Study
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