Back to resultsA 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)
Primary Purpose
Keratoconjunctivitis Sicca
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
voclosporin ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconjunctivitis Sicca
Eligibility 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
Sites / Locations
- Product Investigations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
LX214 0.02%
LX214 0.2%
placebo
Arm Description
LX214 ophthalmic solution 0.02%
placebo
Outcomes
Primary Outcome Measures
ocular irritation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00851734
Brief Title
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)
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 Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lux Biosciences, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconjunctivitis Sicca
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LX214 0.02%
Arm Type
Experimental
Arm Description
LX214 ophthalmic solution 0.02%
Arm Title
LX214 0.2%
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
voclosporin ophthalmic solution
Intervention Description
0.02%, 0.2% t.i.d. or b.i.d.
Primary Outcome Measure Information:
Title
ocular irritation
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Product Investigations
City
Conshohocken
State/Province
Pennsylvania
ZIP/Postal Code
19428
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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)
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