Efficacy and Safety of XG-104 for the Treatment of Dry Eye
- Registration Number
- NCT02235259
- Lead Sponsor
- Xigen SA
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description XG-104 intermediate dose XG-104 - XG-104 low dose XG-104 - Placebo Placebo Placebo XG-104 high dose XG-104 -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Tear Film Break-up Time (Pre- and Post-CAESM) Day 29 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 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
Trial Locations
- Locations (1)
Andover Eye Associates
🇺🇸Andover, Massachusetts, United States