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NCT00851734 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study of Keratoconjunctivitis Sicca, sponsored by Lux Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT00851734: Completed Phase 1 study of Keratoconjunctivitis Sicca, sponsored by Lux Biosciences.
NCT00851734 is a Phase 1 study of Keratoconjunctivitis Sicca that has completed, run by Lux Biosciences. The registered enrollment target is 35 participants, below the 174-participant average among 10 other Keratoconjunctivitis Sicca trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00851734, a Phase 1 study of Keratoconjunctivitis Sicca, has completed, sponsored by Lux Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG voclosporin ophthalmic solution
Study Locations (1)
Pennsylvania
- Product Investigations - Conshohocken
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2009-02 |
| Est. Completion | 2009-04 |
| Phase | Phase 1 |
What the finished NCT00851734 record still lists
NCT00851734 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 174-participant average among 10 other Keratoconjunctivitis Sicca trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Keratoconjunctivitis Sicca appearing as the primary indexed condition, and to 1 intervention - of which voclosporin ophthalmic solution is the first listed.
NCT00851734 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00851734 about?
NCT00851734 is a clinical study titled "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)". 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.
What is the current status of trial NCT00851734?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2009-02. Estimated completion is 2009-04.
What conditions does trial NCT00851734 study?
This clinical trial studies the following conditions: Keratoconjunctivitis Sicca.
What interventions are being tested in trial NCT00851734?
The interventions under investigation include: voclosporin ophthalmic solution (DRUG).
Who is sponsoring clinical trial NCT00851734?
This trial is sponsored by Lux Biosciences, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00851734 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00851734's enrollment target sits among peer trials
35 7th of 10 higher than 4 of 10 other Keratoconjunctivitis Sicca trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Keratoconjunctivitis Sicca trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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