Status:
COMPLETED
Efficacy and Safety of XG-104 for the Treatment of Dry Eye
Lead Sponsor:
Xigen SA
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this study is to assess the safety and efficacy of XG-104 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye after a 4 week Three Times a D...
Eligibility Criteria
Inclusion
- Be at least 18 years of age
- Provide written informed consent
- Have a subject reported history of dry eye
- Have a history of use or desire to use eye drops
Exclusion
- Have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the Investigator may interfere with study parameters;
- Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
- Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
- Have used Restasis® within 30 days of Visit 1;
- Have any planned ocular and/or lid surgeries over the study period;
- Be a woman who is pregnant, nursing or planning a pregnancy;
- Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 4 (or early termination visit) if of childbearing potential.
- Have a known allergy and/or sensitivity to the study drug or its components
- Have a condition or be in a situation which the Investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
- Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;
- Be unable or unwilling to follow instructions, including participation in all study assessments and visits
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT02235259
Start Date
September 1 2014
End Date
February 1 2015
Last Update
July 18 2016
Active Locations (1)
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1
Andover Eye Associates
Andover, Massachusetts, United States, 01810