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)

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lux Biosciences, Inc.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• No systemic disease as determined by a physical examination, clinical laboratory evaluation, and an ECG

• Schirmer's I Test ≥ 10mm/5 minutes with anesthesia

• Corrected Snellen acuity of 20/40 or better in both eyes

Exclusion Criteria:

• Subjects diagnosed with any ocular disease other than refraction error

• Subjects with intraocular pressure >21 mmHg

• Use of a contact lens within 7 days prior to administration of the first dose

• Subjects with history of ocular surgery

• Subjects with a history of laser refractive surgery