24 Hour IOP Lowering Efficacy of AL-3789

Alcon

Status and phase: Completed; Phase 2

Conditions: Open-angle Glaucoma

Treatments: Drug: AL-3789 Sterile Suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT00643669

C-07-65

Details and patient eligibility

About

The objective of this study was to describe the intraocular pressure-lowering efficacy of AL-3789 over a 24-hour period in patients with open-angle glaucoma compared to an untreated control. Patients received one treatment of AL-3789. Twenty-eight days after treatment, IOP was measured every 4 hours, beginning at 8 AM for 24 hours.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of open-angle glaucoma and treated for at least 30 days prior to Screening Visit with a topical prostaglandin analog as monotherapy.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Pregnant, intend to become pregnant, breastfeeding.
• Difference in IOP greater than 3 mm Hg between eyes at Screening Visit.
• Any form of glaucoma other than open-angle glaucoma.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

25 participants in 2 patient groups

AL-3789

Experimental group

Description:

AL-3789 Sterile Suspension, single depot administration of 0.8 mL in the study eye

Treatment:

Drug: AL-3789 Sterile Suspension

No treatment

No Intervention group

Description:

Fellow eye, as randomized