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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: XG-104
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |