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OpenTrials
Completed

NCT Number: NCT00851734

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.

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Key information

Conditions

Keratoconjunctivitis Sicca Conjunctival Diseases Conjunctivitis Corneal Diseases Dry Eye Syndromes Eye Diseases Keratitis Keratoconjunctivitis Lacrimal Apparatus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Product Investigations

Conshohocken, Pennsylvania, 19428, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Voclosporin Ophthalmic Solution

Drug

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

Primary outcomes

  1. ocular irritation

    Time frame: 12 hours

Sponsors and collaborators

Lead sponsor

Lux Biosciences, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 26, 2009
Registry last updated
Jun 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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