Overview

Efficacy and Safety of XG-104 for the Treatment of Dry Eye

Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
0
Participant gender:
All
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 Day (TID) treatment period
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Xigen SA
Criteria
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