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)

Keratoconjunctivitis Sicca Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851734
• Other study ID #: LX214-01
• Status: Completed
• Phase: Phase 1
• First received: February 24, 2009
• Last updated: June 21, 2012
• Start date: February 2009
• Est. completion date: April 2009

Study information

• Verified date: June 2012
• Source: Lux Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Drug:
• voclosporin ophthalmic solution
0.02%, 0.2% t.i.d. or b.i.d.

Locations

Country	Name	City	State
United States	Product Investigations	Conshohocken	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Lux Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ocular irritation		12 hours	Yes