Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00851734
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : June 22, 2012
Sponsor:
Information provided by (Responsible Party):
Lux Biosciences, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : February 2009
Actual Primary Completion Date : March 2009
Actual Study Completion Date : April 2009
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. ocular irritation [ Time Frame: 12 hours ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851734


Locations
Layout table for location information
United States, Pennsylvania
Product Investigations
Conshohocken, Pennsylvania, United States, 19428
Sponsors and Collaborators
Lux Biosciences, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Lux Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00851734    
Other Study ID Numbers: LX214-01
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012
Additional relevant MeSH terms:
Layout table for MeSH terms
Keratoconjunctivitis
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctivitis
Conjunctival Diseases
Eye Diseases
 Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions