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The primary objective of this study is to assess the efficacy and safety of 2 concentrations of RX-10045 ophthalmic solution, 0.05% and 0.1%, compared to placebo for the treatment of ocular inflammation and pain in subjects undergoing cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RX-10045 0.05% nanomicellar solution | Experimental | topical eye drops |
|
| RX-10045 0.1% nanomicellar solution | Experimental | topical eye drops |
|
| Vehicle | Placebo Comparator | topical eye drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RX-10045 | Drug | topical therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Clearing of Anterior Inflammation | score of zero for the Standardization of Uveitis Nomenclature scale | Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Reporting no Ocular Pain | Day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomasz Sablinski, MD | Auven Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auven Therapeutics | Murray Hill | New Jersey | 07974 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | RX-10045 0.05% Nanomicellar Solution | topical eye drops RX-10045: topical therapy |
| FG001 | RX-10045 0.1% Nanomicellar Solution | topical eye drops RX-10045: topical therapy |
| FG002 | Vehicle | topical eye drops RX-10045: topical therapy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RX-10045 0.05% Nanomicellar Solution | topical eye drops RX-10045: topical therapy |
| BG001 | RX-10045 0.1% Nanomicellar Solution | topical eye drops RX-10045: topical therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Subjects With Clearing of Anterior Inflammation | score of zero for the Standardization of Uveitis Nomenclature scale | ITT | Posted | Count of Participants | Participants | Day 8 |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RX-10045 0.05% Nanomicellar Solution | topical eye drops RX-10045: topical therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| S Weiss | Auven Therapeutics | 201 486-0396 | sid.weiss@auventx.com |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010146 | Pain |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C000603302 | isopropyl 5,12-hydroxypentadeca-8,10-dien-6,14-diynoate |
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| Withdrawal by Subject |
|
| Other |
|
| BG002 | Vehicle | topical eye drops RX-10045: topical therapy |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
topical eye drops
RX-10045: topical therapy
|
|
| Secondary | Proportion of Subjects Reporting no Ocular Pain | Posted | Count of Participants | Participants | Day 3 |
|
|
|
| 0 |
| 79 |
| 0 |
| 79 |
| 0 |
| 79 |
| EG001 | RX-10045 0.1% Nanomicellar Solution | topical eye drops RX-10045: topical therapy | 0 | 79 | 0 | 79 | 0 | 79 |
| EG002 | Vehicle | topical eye drops RX-10045: topical therapy | 0 | 78 | 0 | 78 | 0 | 78 |
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| D007905 | Lens Diseases |
| D005128 | Eye Diseases |