Keratoconjunctivitis Sicca Clinical Trial
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
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Product Investigations | Conshohocken | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Lux Biosciences, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ocular irritation | 12 hours | Yes |
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