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)
Part of paid clinical trials in Conshohocken, Pennsylvania.
- Sponsor
- Lux Biosciences, Inc.
- Study ID
- NCT00851734
- Phase
- PHASE1
- Status
- Completed
Conditions
- Keratoconjunctivitis Sicca
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 55 Years
- Healthy Volunteers
- Accepted
Interventions
- voclosporin ophthalmic solution — DRUG0.02%, 0.2% t.i.d. or b.i.d.
Study Details
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.
Key Dates
- Start date
- Feb 28, 2009
- Status verified
- Jun 2012
- Primary completion
- Mar 31, 2009
- Completion
- Apr 30, 2009
Study Design
- Enrollment
- 35 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: LX214 0.02%LX214 ophthalmic solution 0.02%
- Experimental: LX214 0.2%
- Placebo Comparator: placeboplacebo
Primary Outcome Measure
ocular irritation [ Time Frame: 12 hours ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Product Investigations | Conshohocken | Pennsylvania | 19428 | - |
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