AL-54478 Proof of Concept Study

NCT01318252 | Completed Phase 2

• 1 other identifier: C-10-080
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Elevated IOP

Outcome Measures

Primary Outcomes (1)

• 24-hour Area Under the Curve (AUC) for IOP Change from Baseline after 14 Days of Once Daily Dosing

  Day 14

Study Arms (3)

AL-54478

EXPERIMENTAL

AL-54478 0.005%, single dose, followed 7 days later with 14 days of once daily dosing

Drug: AL-54478 0.005%

Latanoprost

ACTIVE COMPARATOR

Latanoprost 0.005%, single dose, followed 7 days later with 14 days of once daily dosing

Drug: Latanoprost 0.005%

Vehicle

PLACEBO COMPARATOR

AL-54478 Vehicle, single dose, followed 7 days later with 14 days of once daily dosing

Drug: AL-54478 Vehicle

Interventions

AL-54478 0.005% DRUG

AL-54478

Latanoprost 0.005% DRUG

Latanoprost

AL-54478 Vehicle DRUG

Inactive ingredients used as a placebo comparator

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Officials

• Ravaughn Williams

  Alcon Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2011
• First Posted: March 18, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: July 31, 2014

Record last verified: 2014-07