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)

Completed · Phase 1 · Has a placebo group

Conditions studied: Keratoconjunctivitis Sicca

In brief

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.

Key facts

Study ID

NCT00851734

Run by

Lux Biosciences, Inc.

People needed

35

Starts

2009-02-01

Expected to finish

2009-04-01

Last updated by the study team

2012-06-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Product Investigations — Conshohocken, Pennsylvania, United States

Full record on ClinicalTrials.gov

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