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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00851734
Other study ID # LX214-01
Secondary ID
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


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
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