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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 is a Phase 1 study of Keratoconjunctivitis Sicca that has completed, run by Lux Biosciences. The registered enrollment target is 35 participants, below the 168-participant average among 9 other Keratoconjunctivitis Sicca trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state.

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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

FieldValue
Enrollment Target 35 participants
Start Date 2009-02
Est. Completion 2009-04
Phase Phase 1

Sponsor

Lux Biosciences

7 total trials

What the Registry Record Tells You About NCT00851734

The ClinicalTrials.gov registry entry for NCT00851734 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 168-participant average among 9 other Keratoconjunctivitis Sicca trials with a reported enrollment target (79% lower). The listed sponsor is Lux Biosciences, which has 7 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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