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