AL-54478 Proof of Concept Study

Alcon

Status and phase: Completed; Phase 2

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

Treatments: Drug: AL-54478 0.005%; Drug: Latanoprost 0.005%; Drug: AL-54478 Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01318252

C-10-080

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 3 patient groups, including a placebo group

AL-54478

Experimental group

Description:

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

Treatment:

Drug: AL-54478 0.005%

Latanoprost

Active Comparator group

Description:

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

Treatment:

Drug: Latanoprost 0.005%

Vehicle

Placebo Comparator group

Description:

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

Treatment:

Drug: AL-54478 Vehicle