AL-54478 Proof of Concept Study

Ocular Hypertension (OHT) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01318252
• Other study ID #: C-10-080
• Status: Completed
• Phase: Phase 2
• First received: March 16, 2011
• Last updated: July 28, 2014
• Start date: June 2011
• Est. completion date: October 2011

Study information

• Verified date: July 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension
• Ocular Hypertension (OHT)
• Open-angle Glaucoma (OAG)

Intervention

Drug:
• AL-54478 0.005%

• Latanoprost 0.005%

• AL-54478 Vehicle
Inactive ingredients used as a placebo comparator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour Area Under the Curve (AUC) for IOP Change from Baseline after 14 Days of Once Daily Dosing		Day 14	No