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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Placebo; Drug: XG-104

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: XG-104 low dose	Drug: XG-104; Comparison of XG-104 (3 concentrations) versus placebo eye drops efficacy
Experimental: XG-104 intermediate dose	Drug: XG-104; Comparison of XG-104 (3 concentrations) versus placebo eye drops efficacy
Experimental: XG-104 high dose	Drug: XG-104; Comparison of XG-104 (3 concentrations) versus placebo eye drops efficacy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Corneal Fluorescein Staining: in the inferior region change from Pre-CAESM to Post- CAESM, as measured by the Ora CalibraTM Scale	Day 29
Worst Dry Eye Symptom	From D22 to Day 28

Secondary Outcome Measures

Outcome Measure	Time Frame
Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM	Day 15
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 15
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 15
Tear Film Break-up Time (Pre- and Post-CAESM)	Day 29
Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM)	Day 15
Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM)	Day 29
Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM)	Day 15
Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM)	Day 29
Tear Osmolarity (Post-CAESM)	Day 1
Tear Osmolarity (Post-CAESM)	Day 29
Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology	Day 15
Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology	Day 29
Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology	Day 15
Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology	Day 29
Unanesthetized Schirmer's Test (Pre-CAESM)	Day 15
Unanesthetized Schirmer's Test (Pre-CAESM)	Day 29
Drop Comfort and Symptom Assessment using Ora Calibra™ Scales	Day 1
Drop Comfort and Symptom Assessment using Ora Calibra™ Scales	Day 15
Ocular Surface Disease Index (OSDI) (Pre-CAESM)	Day 15
Ocular Surface Disease Index (OSDI) (Pre-CAESM)	Day 29
Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM)	Day 15
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 15
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 15
Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure)	Day 29
Daily diary	up to Day 29

Other Outcome Measures

Outcome Measure	Time Frame
Visual Acuity (ETDRS) (Pre-CAESM)	Day -7
Visual Acuity (ETDRS) (Pre-CAESM)	Day 1
Visual Acuity (ETDRS) (Pre-CAESM)	Day 15
Visual Acuity (ETDRS) (Pre-CAESM)	Day 29
Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)	Day -7
Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)	Day 1
Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)	Day 15
Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)	Day 29
Adverse event query	up to Day 29
Dilated Fundoscopy Biomicroscopy	Day -7
Dilated Fundoscopy Biomicroscopy	Day 29
Intraocular Pressure	Day -7
Intraocular Pressure	Day 29

Collaborators and Investigators

• Sponsor: Xigen SA

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: September 5, 2014
• First Submitted That Met QC Criteria: September 5, 2014
• First Posted (Estimate): September 9, 2014

Study Record Updates

• Last Update Posted (Estimate): July 18, 2016
• Last Update Submitted That Met QC Criteria: July 15, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: SDD-1004-059