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 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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00851734

Enrollment

Registered

2009-02-26

Start date

2009-02-28

Completion date

2009-04-30

Last updated

2012-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconjunctivitis Sicca

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.

Interventions

DRUGvoclosporin ophthalmic solution

0.02%, 0.2% t.i.d. or b.i.d.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
ocular irritation	12 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026