NCT01528111

Study to Evaluate the Safety, Tolerability, and Efficacy of LX7101 in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

A Phase 1/2a, Randomized, Parallel-group, Double-masked, Vehicle-controlled, Dose-frequency Escalation Study to Evaluate the Safety, Tolerability, and Intraocular Pressure (IOP)-Lowering Efficacy of Topically Administered LX7101 in Subjects Diagnosed With Primary Open-angle Glaucoma (POAG) or Ocular Hypertension (OHT)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 1/2a study is intended to assess the safety, tolerability, and effects on intraocular pressure of two dose levels and two dose frequencies of LX7101 when administered topically in the eyes of patients diagnosed with primary open-angle glaucoma or ocular hypertension.

Conditions

• Primary Open-angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	LX7101 (0.125%)	Subjects will receive 0.125% LX7101
DRUG	LX7101 (0.25%)	Subjects will receive 0.25% LX7101
DRUG	LX7101 Vehicle	Subjects will receive vehicle

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2012-02-07
• Last updated: 2015-09-14

Locations

5 sites across 1 country: United States