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

Use our guide to learn which trials are right for you!

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


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
We found this trial at
1
site
Andover, Massachusetts 01810
?
mi
from
Andover, MA
Click here to add this to my saved trials