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)
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
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 24, 2009
CompletedFirst Posted
Study publicly available on registry
February 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedJune 22, 2012
June 1, 2012
28 days
February 24, 2009
June 21, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
ocular irritation
12 hours
Study Arms (3)
LX214 0.02%
EXPERIMENTALLX214 ophthalmic solution 0.02%
LX214 0.2%
EXPERIMENTALplacebo
PLACEBO COMPARATORplacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Product Investigations
Conshohocken, Pennsylvania, 19428, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2009
First Posted
February 26, 2009
Study Start
February 1, 2009
Primary Completion
March 1, 2009
Study Completion
April 1, 2009
Last Updated
June 22, 2012
Record last verified: 2012-06