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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)

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ClinicalTrials.gov Identifier: NCT00851734
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : June 22, 2012
Sponsor:
Information provided by (Responsible Party):
Lux Biosciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Keratoconjunctivitis Sicca Drug: voclosporin ophthalmic solution Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2009
Actual Primary Completion Date : March 2009
Actual Study Completion Date : April 2009

Arm Intervention/treatment
Experimental: LX214 0.02%
LX214 ophthalmic solution 0.02%
Drug: voclosporin ophthalmic solution
0.02%, 0.2% t.i.d. or b.i.d.

Experimental: LX214 0.2% Drug: voclosporin ophthalmic solution
0.02%, 0.2% t.i.d. or b.i.d.

Placebo Comparator: placebo
placebo
Drug: voclosporin ophthalmic solution
0.02%, 0.2% t.i.d. or b.i.d.




Primary Outcome Measures :
  1. ocular irritation [ Time Frame: 12 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851734


Locations
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United States, Pennsylvania
Product Investigations
Conshohocken, Pennsylvania, United States, 19428
Sponsors and Collaborators
Lux Biosciences, Inc.

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Responsible Party: Lux Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00851734     History of Changes
Other Study ID Numbers: LX214-01
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012
Additional relevant MeSH terms:
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Keratoconjunctivitis
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions