NCT00851734

A Dose-Escalation Study to Assess the Safety and Tolerability of LX214 Ophthalmic Solution in Healthy Volunteers, Followed by an Open-Label Evaluation of LX214 in Patients With Keratoconjunctivitis Sicca (KCS)

A Phase 1 Dose-Escalation Study To Assess the Safety and Tolerability of LX214 Ophthalmic Solution in Healthy Volunteers, Followed By an Open-Label Evaluation of LX214 Ophthalmic Solution in Patients With Keratoconjunctivitis Sicca

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Lux Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a first-in-man study for the purpose of determining the safety and tolerability of LX214 ophthalmic solution in healthy volunteers and in patients with dry eye syndrome.

Conditions

• Keratoconjunctivitis Sicca

Interventions

Type	Name	Description
DRUG	voclosporin ophthalmic solution	0.02%, 0.2% t.i.d. or b.i.d.

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-03-01
• Completion: 2009-04-01
• First posted: 2009-02-26
• Last updated: 2012-06-22

Locations

1 site across 1 country: United States