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| Name | Class |
|---|---|
| Glia, LLC | INDUSTRY |
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To evaluate the safety and efficacy of 1% Pro-ocular topical gel administered twice daily for 12 weeks in treatment of Dry Eye Disease
Pro-ocular™ 1% topical gel his demonstrated efficacy in rapidly reducing or eliminating dry eye symptoms, and after multiple doses, the signs and symptoms of ocular surface disease including dry eye disease.
Study DE-2 is single center, randomized, double-masked, placebo-controlled, parallel-group study designed to evaluate the safety and efficacy of 1% Pro-ocular topical gel administered twice daily for 12 weeks for treatment of Dry Eye Disease. The approximately 80 subjects will be randomized 1:1, active drug:placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pro-ocular™ | Active Comparator | Pro-ocular™ Topical Gel |
|
| Placebo | Placebo Comparator | Placebo Topical Gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pro-ocular™ Topical Gel | Drug | Pro-ocular™ Topical Gel 1% is applied dermally to the forehead twice-daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score | Change from baseline in SANDE symptoms frequency score (0-100 worst) | 2 weeks |
| Change in corneal (central) fluorescein staining score | Change from baseline in score on a visual analog scale (0-10 worst) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score | Change from baseline in SANDE symptoms global score (0-100 worst) | 2 weeks |
| Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score |
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Inclusion Criteria:
Male or female of any race, at least 20 years of age at Visit 1 Screening.
Has a subject reported history (including physician diagnosis) of dry eye disease in both eyes for at least 3 months prior to Visit 1.
Has SANDE score ≥50 in either frequency or severity of symptoms of dryness and/or irritation at Visit 1.
Have all of the following in the same eye at Visit 1:
Has provided written informed consent.
Be able and willing to follow oral and written instructions, including participation in all study assessments and visits.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peichun Kuo | PharmaDax Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri-Service General Hospital, National Defense Medical Center | Taipei | 11490 | Taiwan |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D007638 | Keratoconjunctivitis Sicca |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
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| Placebo Topical Gel | Drug | Placebo is a toopical gel without active ingredient applied dermally to the forehead twice-daily |
|
Change from baseline in SANDE symptoms global score (0-100 worst)
| 4 weeks |
| Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score | Change from baseline in SANDE symptoms global score (0-100 worst) | 8 weeks |
| Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score | Change from baseline in SANDE symptoms global score (0-100 worst) | 12 weeks |
| Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score | Change from baseline in SANDE symptoms frequency score (0-100 worst) | 4 weeks |
| Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score | Change from baseline in SANDE symptoms frequency score (0-100 worst) | 8 weeks |
| Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score | Change from baseline in SANDE symptoms frequency score (0-100 worst) | 12 weeks |
| Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score | Change from baseline in SANDE symptoms severity score (0-100 worst) | 2 weeks |
| Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score | Change from baseline in SANDE symptoms severity score (0-100 worst) | 4 weeks |
| Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score | Change from baseline in SANDE symptoms severity score (0-100 worst) | 8 weeks |
| Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score | Change from baseline in SANDE symptoms severity score (0-100 worst) | 12 weeks |
| Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score | Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst) | 1 hour |
| Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score | Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst) | 2 weeks |
| Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score | Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst) | 4 weeks |
| Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score | Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst) | 8 weeks |
| Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score | Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst) | 12 weeks |
| Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores | Change from baseline in GLIA OSDSQ sum of scores (highest worst) | 1 hour |
| Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores | Change from baseline in GLIA OSDSQ sum of scores (highest worst) | 2 weeks |
| Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores | Change from baseline in GLIA OSDSQ sum of scores (highest worst) | 4 weeks |
| Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores | Change from baseline in GLIA OSDSQ sum of scores (highest worst) | 8 weeks |
| Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores | Change from baseline in GLIA OSDSQ sum of scores (highest worst) | 12 weeks |
| Change in Tear Film Grading by TearScan examination | Change from baseline in tear film grade (0-3 best) | 1 hour |
| Change in Tear Film Grading by TearScan examination | Change from baseline in tear film grade (0-3 best) | 2 weeks |
| Change in Tear Film Grading by TearScan examination | Change from baseline in tear film grade (0-3 best) | 4 weeks |
| Change in Tear Film Grading by TearScan examination | Change from baseline in tear film grade (0-3 best) | 8 weeks |
| Change in Tear Film Grading by TearScan examination | Change from baseline in tear film grade (0-3 best) | 12 weeks |
| Change in Meibography score by Keratograph® | Change from baseline using Grades 0 to 3 (0 no loss to 3 >2/3 loss) | 12 weeks |
| Change in Tear Meniscus Height (TMH) by Keratograph® | Change from baseline in mm TMH (higher is better) | 1 hour |
| Change in Tear Meniscus Height (TMH) by Keratograph® | Change from baseline in mm TMH (higher is better) | 4 weeks |
| Change in Tear Meniscus Height (TMH) by Keratograph® | Change from baseline in mm TMH (higher is better) | 8 weeks |
| Change in Tear Meniscus Height (TMH) by Keratograph® | Change from baseline in mm TMH (higher is better) | 12 weeks |
| Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT) | Change from baseline in NIKBUT in seconds (longer is better) | 1 hour |
| Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT) | Change from baseline in NIKBUT in seconds (longer is better) | 4 weeks |
| Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT) | Change from baseline in NIKBUT in seconds (longer is better) | 8 weeks |
| Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT) | Change from baseline in NIKBUT in seconds (longer is better) | 12 weeks |
| Change in Bulbar redness score by Keratograph® | Change from baseline in Bulbar redness score (highest is worst) | 1 hour |
| Change in Bulbar redness score by Keratograph® | Change from baseline in Bulbar redness score (highest is worst) | 4 weeks |
| Change in Bulbar redness score by Keratograph® | Change from baseline in Bulbar redness score (highest is worst) | 8 weeks |
| Change in Bulbar redness score by Keratograph® | Change from baseline in Bulbar redness score (highest is worst) | 12 weeks |
| Change in tear film osmolarity by TearLab™ osmolarity system | Change from baseline in mOsms/L (higher value is worse) | 1 hour |
| Change in tear film osmolarity by TearLab™ osmolarity system | Change from baseline in mOsms/L (higher value is less sensitive) | 2 weeks |
| Change in corneal sensitivity using Cochet-Bonnet esthesiometer | Change from baseline in mm Hg (higher is less sensitive) | 1 hour |
| Change in corneal sensitivity using Cochet-Bonnet esthesiometer | Change from baseline in mm Hg (higher is less sensitive) | 2 weeks |
| Change in corneal sensitivity using Cochet-Bonnet esthesiometer | Change from baseline in mm Hg (higher is less sensitive) | 4 weeks |
| Change in corneal sensitivity using Cochet-Bonnet esthesiometer | Change from baseline in mm Hg (higher is less sensitive) | 8 weeks |
| Change in corneal sensitivity using Cochet-Bonnet esthesiometer | Change from baseline in mm Hg (higher is less sensitive) | 12 weeks |
| Change in Fluorescein Tear Break-Up Time (FBUT) | Change from baseline in FBUT in seconds (longer is better) | 1 hour |
| Change in Fluorescein Tear Break-Up Time (FBUT) | Change from baseline in FBUT in seconds (longer is better) | 4 weeks |
| Change in Fluorescein Tear Break-Up Time (FBUT) | Change from baseline in FBUT in seconds (longer is better) | 8 weeks |
| Change in Fluorescein Tear Break-Up Time (FBUT) | Change from baseline in FBUT in seconds (longer is better) | 12 weeks |
| Change in corneal (central) fluorescein staining score | Change from baseline in central corneal fluorescein staining score (0-10 worst) | 2 weeks |
| Change in corneal (central) fluorescein staining score | Change from baseline in central corneal fluorescein staining score (0-10 worst) | 8 weeks |
| Change in corneal (central) fluorescein staining score | Change from baseline in central corneal fluorescein staining score (0-10 worst) | 12 weeks |
| Change in corneal (inferior) fluorescein staining score | Change from baseline in inferior corneal fluorescein staining score (0-10 worst) | 2 weeks |
| Change in corneal (inferior) fluorescein staining score | Change from baseline in inferior corneal fluorescein staining score (0-10 worst) | 4 weeks |
| Change in corneal (inferior) fluorescein staining score | Change from baseline in inferior corneal fluorescein staining score (0-10 worst) | 8 weeks |
| Change in corneal (inferior) fluorescein staining score | Change from baseline in inferior corneal fluorescein staining score (0-10 worst) | 12 weeks |
| Change in corneal (superior) fluorescein staining score | Change from baseline in superior corneal fluorescein staining score (0-10 worst) | 2 weeks |
| Change in corneal (superior) fluorescein staining score | Change from baseline in superior corneal fluorescein staining score (0-10 worst) | 4 weeks |
| Change in corneal (superior) fluorescein staining score | Change from baseline in superior corneal fluorescein staining score (0-10 worst) | 8 weeks |
| Change in corneal (superior) fluorescein staining score | Change from baseline in superior corneal fluorescein staining score (0-10 worst) | 12 weeks |
| Change in corneal fluorescein staining sum of scores | Change from baseline in corneal fluorescein staining sum of scores (0-30 worst) | 2 weeks |
| Change in corneal fluorescein staining sum of scores | Change from baseline in corneal fluorescein staining sum of scores (0-30 worst) | 4 weeks |
| Change in corneal fluorescein staining sum of scores | Change from baseline in corneal fluorescein staining sum of scores (0-30 worst) | 8 weeks |
| Change in corneal fluorescein staining sum of scores | Change from baseline in corneal fluorescein staining sum of scores (0-30 worst) | 12 weeks |
| Change in conjunctival fluorescein staining sum of scores | Change from baseline in conjunctival fluorescein staining sum of scores (0-30 worst) | 2 weeks |
| Change in conjunctival fluorescein staining sum of scores | Change from baseline in conjunctival fluorescein staining sum of scores (0-30 worst) | 4 weeks |
| Change in conjunctival fluorescein staining sum of scores | Change from baseline in conjunctival fluorescein staining sum of scores (0-30 worst) | 8 weeks |
| Change in conjunctival fluorescein staining sum of scores | Change from baseline in conjunctival fluorescein staining sum of scores (0-30 worst) | 12 weeks |
| Change in lissamine green staining (corneal and conjunctival) sum of scores | Change from baseline in lissamine green staining (corneal and conjunctival) sum of scores | 2 weeks |
| Change in lissamine green staining (corneal and conjunctival) sum of scores | Change from baseline in lissamine green staining (corneal and conjunctival) sum of scores (higher is worse) | 4 weeks |
| Change in lissamine green staining (corneal and conjunctival) sum of scores | Change from baseline in lissamine green staining (corneal and conjunctival) sum of scores (higher is worse) | 8 weeks |
| Change in lissamine green staining (corneal and conjunctival) sum of scores | Change from baseline in lissamine green staining (corneal and conjunctival) sum of scores (higher is worse) | 12 weeks |
| Change in conjunctival hyperemia (by slit lamp biomicroscopy) | Change from baseline in conjunctival hyperemia score (0-10 worst) | 2 weeks |
| Change in conjunctival hyperemia (by slit lamp biomicroscopy) | Change from baseline in conjunctival hyperemia score (0-10 worst) | 4 weeks |
| Change in conjunctival hyperemia (by slit lamp biomicroscopy) | Change from baseline in conjunctival hyperemia score (0-10 worst) | 8 weeks |
| Change in conjunctival hyperemia (by slit lamp biomicroscopy) | Change from baseline in conjunctival hyperemia score (0-10 worst) | 12 weeks |
| D003229 |
| Conjunctival Diseases |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |