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)

June 21, 2012 updated by: Lux Biosciences, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Conshohocken, Pennsylvania, United States, 19428
        • Product Investigations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ocular irritation
Time Frame: 12 hours
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lux Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

February 24, 2009

First Submitted That Met QC Criteria

February 25, 2009

First Posted (Estimate)

February 26, 2009

Study Record Updates

Last Update Posted (Estimate)

June 22, 2012

Last Update Submitted That Met QC Criteria

June 21, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LX214-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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