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

Primary Purpose

Dry Eye

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

XG-104

Placebo

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Andover Eye Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

XG-104 low dose

XG-104 intermediate dose

XG-104 high dose

Placebo

Arm Description

Placebo

Outcomes

Primary Outcome Measures

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

Worst Dry Eye Symptom

Secondary Outcome Measures

Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM

Lissamine Green Staining using Ora Calibra™ Scale and NEI Scale (all regions) (Pre- and Post-CAESM and change from Pre- to Post-CAESM

Tear Film Break-up Time (Pre- and Post-CAESM)

Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM)

Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM)

Tear Osmolarity (Post-CAESM)

Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology

Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology

Unanesthetized Schirmer's Test (Pre-CAESM)

Drop Comfort and Symptom Assessment using Ora Calibra™ Scales

Ocular Surface Disease Index (OSDI) (Pre-CAESM)

Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM)

Ocular Discomfort using Ora Calibra™ Discomfort and 4-Symptom Questionnaire (Pre and Post-CAESM)

Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure)

Daily diary

Full Information

NCT ID

NCT02235259

First Posted

September 5, 2014

Last Updated

July 15, 2016

Sponsor

Xigen SA

1. Study Identification

Unique Protocol Identification Number

NCT02235259

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xigen SA

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

260 (Actual)

8. Arms, Groups, and Interventions

Arm Title

XG-104 low dose

Arm Type

Experimental

Arm Title

XG-104 intermediate dose

Arm Type

Experimental

Arm Title

XG-104 high dose

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

XG-104

Intervention Description

Comparison of XG-104 (3 concentrations) versus placebo eye drops efficacy

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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

Title

Worst Dry Eye Symptom

Time Frame

From D22 to Day 28

Secondary Outcome Measure Information:

Title

Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM

Time Frame

Day 15

Title

Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM

Time Frame

Day 29

Title

Lissamine Green Staining using Ora Calibra™ Scale and NEI Scale (all regions) (Pre- and Post-CAESM and change from Pre- to Post-CAESM

Time Frame

Day 15

Title

Lissamine Green Staining using Ora Calibra™ Scale and NEI Scale (all regions) (Pre- and Post-CAESM and change from Pre- to Post-CAESM

Time Frame

Day 29

Title

Tear Film Break-up Time (Pre- and Post-CAESM)

Time Frame

Day 15

Title

Tear Film Break-up Time (Pre- and Post-CAESM)

Time Frame

Day 29

Title

Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM)

Time Frame

Day 15

Title

Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM)

Time Frame

Day 29

Title

Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM)

Time Frame

Day 15

Title

Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM)

Time Frame

Day 29

Title

Tear Osmolarity (Post-CAESM)

Time Frame

Day 1

Title

Tear Osmolarity (Post-CAESM)

Time Frame

Day 29

Title

Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology

Time Frame

Day 15

Title

Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology

Time Frame

Day 29

Title

Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology

Time Frame

Day 15

Title

Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology

Time Frame

Day 29

Title

Unanesthetized Schirmer's Test (Pre-CAESM)

Time Frame

Day 15

Title

Unanesthetized Schirmer's Test (Pre-CAESM)

Time Frame

Day 29

Title

Drop Comfort and Symptom Assessment using Ora Calibra™ Scales

Time Frame

Day 1

Title

Drop Comfort and Symptom Assessment using Ora Calibra™ Scales

Time Frame

Day 15

Title

Ocular Surface Disease Index (OSDI) (Pre-CAESM)

Time Frame

Day 15

Title

Ocular Surface Disease Index (OSDI) (Pre-CAESM)

Time Frame

Day 29

Title

Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM)

Time Frame

Day 15

Title

Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM)

Time Frame

Day 29

Title

Ocular Discomfort using Ora Calibra™ Discomfort and 4-Symptom Questionnaire (Pre and Post-CAESM)

Time Frame

Day 15

Title

Ocular Discomfort using Ora Calibra™ Discomfort and 4-Symptom Questionnaire (Pre and Post-CAESM)

Time Frame

Day 29

Title

Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure)

Time Frame

Day 15

Title

Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure)

Time Frame

Day 29

Title

Daily diary

Time Frame

up to Day 29

Other Pre-specified Outcome Measures:

Title

Visual Acuity (ETDRS) (Pre-CAESM)

Time Frame

Day -7

Title

Visual Acuity (ETDRS) (Pre-CAESM)

Time Frame

Day 1

Title

Visual Acuity (ETDRS) (Pre-CAESM)

Time Frame

Day 15

Title

Visual Acuity (ETDRS) (Pre-CAESM)

Time Frame

Day 29

Title

Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)

Time Frame

Day -7

Title

Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)

Time Frame

Day 1

Title

Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)

Time Frame

Day 15

Title

Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)

Time Frame

Day 29

Title

Adverse event query

Time Frame

up to Day 29

Title

Dilated Fundoscopy Biomicroscopy

Time Frame

Day -7

Title

Dilated Fundoscopy Biomicroscopy

Time Frame

Day 29

Title

Intraocular Pressure

Time Frame

Day -7

Title

Intraocular Pressure

Time Frame

Day 29

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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; Be unable or unwilling to follow instructions, including participation in all study assessments and visits

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gail Torkildsen, MD

Organizational Affiliation

Andover Eye Associates

Official's Role

Principal Investigator

Facility Information:

Facility Name

Andover Eye Associates

City

Andover

State/Province

Massachusetts

ZIP/Postal Code

01810

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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