Efficacy and Safety of XG-104 for the Treatment of Dry Eye
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/8/2015 |
Start Date: | September 2014 |
End Date: | January 2015 |
Contact: | Géraldine Dury |
Email: | gd@xigenpharma.com |
Phone: | + 41 21 321 10 80 |
A Phase II, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of XG-104 Ophthalmic Solutions in the Environment, and During Challenge in the Controlled Adverse Environmental (CAESM ) Model for the Treatment of Dry Eye
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 Day (TID) treatment period
Solution compared to placebo for the treatment of the signs and symptoms of dry eye after a
4 week Three Times a Day (TID) treatment period
Inclusion Criteria:
- 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 Criteria:
- 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
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