Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00851734
Other study ID # LX214-01
Secondary ID
Status Completed
Phase Phase 1
First received February 24, 2009
Last updated June 21, 2012
Start date February 2009
Est. completion date April 2009

Study information

Verified date June 2012
Source Lux Biosciences, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date April 2009
Est. primary completion date March 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
United States Product Investigations Conshohocken Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Lux Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary ocular irritation 12 hours Yes
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05618730 - Safety, Tolerability, Plug Retention and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B Phase 1
Completed NCT02254265 - Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca Phase 2/Phase 3
Completed NCT00883649 - Efficacy and Safety Study of Nutritional Supplements for Treatments of Dry Eye N/A
Completed NCT00128245 - Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca Phase 2
Completed NCT00717418 - Efficacy Study of Cyclosporine Ophthalmic Emulsion in Patients With Dry Eye Disease N/A
Enrolling by invitation NCT03436576 - Efficacy of Two Concentrations of Autologous Serum for the Treatment of Severe Dry Eye Phase 3
Completed NCT04147650 - Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome Phase 2/Phase 3
Completed NCT01733992 - A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease Phase 1
Completed NCT00987727 - Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye Phase 4
Completed NCT00788229 - Efficacy and Safety Study of ATs in Patients With Dry Eye Syndrome Phase 2
Completed NCT00554879 - Acupuncture Treatment of Dry Eye N/A
Completed NCT00407043 - Multicenter, Randomized, Controlled Study of the Effect of Lotemax on Initiation of Dry Eye Treatment With Restasis Phase 4
Completed NCT00001731 - Treatment of Dry Eye Syndrome With Cyclosporin A Eye Drops Phase 2
Recruiting NCT03953703 - Levocarnitine for Dry Eye in Sjogren's Syndrome Phase 2
Withdrawn NCT03398018 - Repository Corticotropin Injection in Keratoconjunctivitis Sicca Phase 4
Recruiting NCT02066896 - Laser Therapy to Treat the Dry Mouth of Sjogren's Syndrome Phase 3
Completed NCT02139033 - A Phase 4 Study Investigating the Efficacy of Retaineā„¢ in Managing Signs and Symptoms Associated With Dry Eye Syndrome Phase 4
Terminated NCT01213342 - Omega-3 Fatty Acid Supplements and Dry Eye N/A
Completed NCT00201955 - Study of Rebamipide Eye Drops to Treat Dry Eye Phase 3
Completed NCT00201981 - Study of Rebamipide Eye Drops to Treat Dry Eye Phase 3