Status:
COMPLETED
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)
Lead Sponsor:
Lux Biosciences, Inc.
Conditions:
Keratoconjunctivitis Sicca
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00851734
Start Date
February 1 2009
End Date
April 1 2009
Last Update
June 22 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Product Investigations
Conshohocken, Pennsylvania, United States, 19428