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

Xigen SA

Status and phase: Completed; Phase 2

Conditions: Dry Eye

Treatments: Drug: Placebo; Drug: XG-104

Study type: Interventional

Funder types: Industry

Identifiers

NCT02235259

SDD-1004-059

Details and patient eligibility

About

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

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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260 participants in 4 patient groups, including a placebo group

XG-104 low dose

Experimental group

Treatment:

Drug: XG-104

XG-104 intermediate dose

Experimental group

Treatment:

Drug: XG-104

XG-104 high dose

Experimental group

Treatment:

Drug: XG-104

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo