Clinical trial NCT02235259: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Lead sponsor: Xigen SA
Sponsor class: INDUSTRY
First posted: 2014-09-09
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Corneal Fluorescein Staining: in the inferior region change from Pre-CAESM to Post- CAESM, as measured by the Ora CalibraTM Scale
timeFrame: Day 29
measure: Worst Dry Eye Symptom
timeFrame: From D22 to Day 28
Secondary outcomes:
measure: Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM
timeFrame: Day 15
measure: Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM
timeFrame: Day 29
measure: Lissamine Green Staining using Ora Calibra™ Scale and NEI Scale (all regions) (Pre- and Post-CAESM and change from Pre- to Post-CAESM
timeFrame: Day 15
measure: Lissamine Green Staining using Ora Calibra™ Scale and NEI Scale (all regions) (Pre- and Post-CAESM and change from Pre- to Post-CAESM
timeFrame: Day 29
measure: Tear Film Break-up Time (Pre- and Post-CAESM)
timeFrame: Day 15
measure: Tear Film Break-up Time (Pre- and Post-CAESM)
timeFrame: Day 29
measure: Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM)
timeFrame: Day 15
measure: Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM)
timeFrame: Day 29
measure: Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM)
timeFrame: Day 15
measure: Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM)
timeFrame: Day 29
measure: Tear Osmolarity (Post-CAESM)
timeFrame: Day 1
measure: Tear Osmolarity (Post-CAESM)
timeFrame: Day 29
measure: Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology
timeFrame: Day 15
measure: Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology
timeFrame: Day 29
measure: Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology
timeFrame: Day 15
measure: Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology
timeFrame: Day 29
measure: Unanesthetized Schirmer's Test (Pre-CAESM)
timeFrame: Day 15
measure: Unanesthetized Schirmer's Test (Pre-CAESM)
timeFrame: Day 29
measure: Drop Comfort and Symptom Assessment using Ora Calibra™ Scales
timeFrame: Day 1
measure: Drop Comfort and Symptom Assessment using Ora Calibra™ Scales
timeFrame: Day 15
measure: Ocular Surface Disease Index (OSDI) (Pre-CAESM)
timeFrame: Day 15
measure: Ocular Surface Disease Index (OSDI) (Pre-CAESM)
timeFrame: Day 29
measure: Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM)
timeFrame: Day 15
measure: Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM)
timeFrame: Day 29
measure: Ocular Discomfort using Ora Calibra™ Discomfort and 4-Symptom Questionnaire (Pre and Post-CAESM)
timeFrame: Day 15
measure: Ocular Discomfort using Ora Calibra™ Discomfort and 4-Symptom Questionnaire (Pre and Post-CAESM)
timeFrame: Day 29
measure: Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure)
timeFrame: Day 15
measure: Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure)
timeFrame: Day 29
measure: Daily diary
timeFrame: up to Day 29
Other outcomes:
measure: Visual Acuity (ETDRS) (Pre-CAESM)
timeFrame: Day -7
measure: Visual Acuity (ETDRS) (Pre-CAESM)
timeFrame: Day 1
measure: Visual Acuity (ETDRS) (Pre-CAESM)
timeFrame: Day 15
measure: Visual Acuity (ETDRS) (Pre-CAESM)
timeFrame: Day 29
measure: Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)
timeFrame: Day -7
measure: Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)
timeFrame: Day 1
measure: Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)
timeFrame: Day 15
measure: Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)
timeFrame: Day 29
measure: Adverse event query
timeFrame: up to Day 29
measure: Dilated Fundoscopy Biomicroscopy
timeFrame: Day -7
measure: Dilated Fundoscopy Biomicroscopy
timeFrame: Day 29
measure: Intraocular Pressure
timeFrame: Day -7
measure: Intraocular Pressure
timeFrame: Day 29
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
affiliation: Andover Eye Associates
name: Gail Torkildsen, MD
role: PRINCIPAL_INVESTIGATOR
References: