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

Xigen SA1 site in 1 country260 target enrollmentSeptember 2014

ConditionsDry Eye

InterventionsXG-104 Placebo

DrugsXG-104 Placebo

Overview

Phase: Phase 2
Intervention: XG-104
Conditions: Dry Eye
Sponsor: Xigen SA
Enrollment: 260
Locations: 1
Primary Endpoint: Corneal Fluorescein Staining: in the inferior region change from Pre-CAESM to Post- CAESM, as measured by the Ora CalibraTM Scale
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

February 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Xigen SA

Responsible Party

Sponsor

Eligibility 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;

Arms & Interventions

XG-104 low dose

Intervention: XG-104

XG-104 intermediate dose

Intervention: XG-104

XG-104 high dose

Intervention: XG-104

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Corneal Fluorescein Staining: in the inferior region change from Pre-CAESM to Post- CAESM, as measured by the Ora CalibraTM Scale

Time Frame: Day 29

Worst Dry Eye Symptom

Time Frame: From D22 to Day 28

Secondary Outcomes

Daily diary(up to Day 29)
Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM(Day 29)
Lissamine Green Staining using Ora Calibra™ Scale and NEI Scale (all regions) (Pre- and Post-CAESM and change from Pre- to Post-CAESM(Day 29)
Tear Film Break-up Time (Pre- and Post-CAESM)(Day 29)
Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM)(Day 29)
Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM)(Day 29)
Tear Osmolarity (Post-CAESM)(Day 29)
Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology(Day 29)
Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology(Day 29)
Unanesthetized Schirmer's Test (Pre-CAESM)(Day 29)
Drop Comfort and Symptom Assessment using Ora Calibra™ Scales(Day 15)
Ocular Surface Disease Index (OSDI) (Pre-CAESM)(Day 29)
Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM)(Day 29)
Ocular Discomfort using Ora Calibra™ Discomfort and 4-Symptom Questionnaire (Pre and Post-CAESM)(Day 29)
Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure)(Day 29)