Efficacy and Safety of XG-104 for the Treatment of Dry Eye
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
| Placebo Comparator: Placebo Placebo |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Andover Eye Associates | Andover | Massachusetts | United States | 01810 |
Sponsors and Collaborators
- Xigen SA
Investigators
- Principal Investigator: Gail Torkildsen, MD, Andover Eye Associates
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SDD-1004-059