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)

• Sponsor: Lux Biosciences, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00851734
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 3
• Duration (Months): 1.9
• Patients Per Site Per Month: 18.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Keratoconjunctivitis Sicca	Drug: voclosporin ophthalmic solution	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LX214 0.02% LX214 ophthalmic solution 0.02%	Drug: voclosporin ophthalmic solution; 0.02%, 0.2% t.i.d. or b.i.d.
Experimental: LX214 0.2%	Drug: voclosporin ophthalmic solution; 0.02%, 0.2% t.i.d. or b.i.d.
Placebo Comparator: placebo placebo	Drug: voclosporin ophthalmic solution; 0.02%, 0.2% t.i.d. or b.i.d.

Outcome Measures

Primary Outcome Measures

1. ocular irritation [12 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Product Investigations	Conshohocken	Pennsylvania	United States	19428

Sponsors and Collaborators

• Lux Biosciences, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lux Biosciences, Inc.
• ClinicalTrials.gov Identifier: NCT00851734
• Other Study ID Numbers: LX214-01
• First Posted: Feb 26, 2009
• Last Update Posted: Jun 22, 2012
• Last Verified: Jun 1, 2012

• Additional relevant MeSH terms: Keratoconjunctivitis; Keratoconjunctivitis Sicca; Dry Eye Syndromes; Ophthalmic Solutions

Study Results

No Results Posted as of Jun 22, 2012