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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XG-104 low dose | Experimental |
| |
| XG-104 intermediate dose | Experimental |
| |
| XG-104 high dose | Experimental |
| |
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XG-104 | Drug | Comparison of XG-104 (3 concentrations) versus placebo eye drops efficacy |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity (ETDRS) (Pre-CAESM) | Day -7 | |
| Visual Acuity (ETDRS) (Pre-CAESM) | Day 1 | |
| Visual Acuity (ETDRS) (Pre-CAESM) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail Torkildsen, MD | Andover Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Placebo | Drug |
|
| 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 |
| 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 |