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)

Phase 1

Completed

• Conditions: Keratoconjunctivitis Sicca
• Interventions: Drug: voclosporin ophthalmic solution

• Registration Number: NCT00851734
• Lead Sponsor: Lux Biosciences, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-24
• Study First Submitted QC: 2009-02-25
• Study First Posted: 2009-02-26
• Primary Completion: 2009-03
• Study Completion: 2009-04
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-21
• Last Update Posted: 2012-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LX214 0.2%	voclosporin ophthalmic solution	-
placebo	voclosporin ophthalmic solution	placebo
LX214 0.02%	voclosporin ophthalmic solution	LX214 ophthalmic solution 0.02%

Primary Outcome Measures

Name	Time	Method
ocular irritation	12 hours

Trial Locations

Locations (1)

Product Investigations; 🇺🇸 Conshohocken, Pennsylvania, United States