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)
NCT ID: NCT00851734
Last Updated: 2012-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
35 participants
INTERVENTIONAL
2009-02-28
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LX214 0.02%
LX214 ophthalmic solution 0.02%
voclosporin ophthalmic solution
0.02%, 0.2% t.i.d. or b.i.d.
LX214 0.2%
voclosporin ophthalmic solution
0.02%, 0.2% t.i.d. or b.i.d.
placebo
placebo
voclosporin ophthalmic solution
0.02%, 0.2% t.i.d. or b.i.d.
Interventions
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voclosporin ophthalmic solution
0.02%, 0.2% t.i.d. or b.i.d.
Eligibility Criteria
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Inclusion Criteria
* Schirmer's I Test ≥ 10mm/5 minutes with anesthesia
* Corrected Snellen acuity of 20/40 or better in both eyes
Exclusion Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Lux Biosciences, Inc.
INDUSTRY
Responsible Party
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Locations
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Product Investigations
Conshohocken, Pennsylvania, United States
Countries
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Other Identifiers
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LX214-01
Identifier Type: -
Identifier Source: org_study_id
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