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A pterygium is a wing-shaped, benign tissue growth which forms on the surface of the conjunctiva and grows towards the cornea. It can eventually lead to vision impairment. The precise cause of pterygium formation is unknown but new blood vessel growth and fibroblastic structures are characteristics of the disease. AG-86893 is an eye drop being developed to treat hyperemia (redness) and growth of the pterygium.
Hypothesis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vehicle Eye Drops | Placebo Comparator | One drop, three times daily to the study eye for 28 days |
|
| 0.1% AG-86893 Eye Drops | Experimental | One drop, three times daily to the study eye for 28 days |
|
| 0.3% AG-86893 Eye Drops | Experimental | One drop, three times daily to the study eye for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.1% AG-86893 Eye Drops | Drug | One drop, three times daily to the study eye for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Overall Conjunctival Hyperemia Score | Assessed by digital ocular photography; each quadrant of the eye (superior, inferior, nasal, temporal) will be scored using a 5-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe) and graded by a reading center. The overall conjunctival score is the average of the four quadrants. Assessments are made by subtracting the score at Baseline from the score on Day 28. An increase in value indicates worsening of hyperemia, while a decrease indicates improvement. | Baseline and Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Conjunctival Hyperemia Score in the Quadrant With the Pterygium | Assessed by digital ocular photography; the quadrant with the pterygium will be scored using a 5-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe) and graded by a reading center. Assessments are made by subtracting the score at Baseline from the score on Day 28. An increase in value indicates worsening of hyperemia, while a decrease indicates improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M.T. Coroneo Pty Ltd | Randwick | New South Wales | Australia | |||
| H2Vision Centre |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle Eye Drops | One drop, three times daily to the study eye for 28 days Vehicle Eye Drops: One drop, three times daily to the study eye for 28 days |
| FG001 | 0.1% AG-86893 Eye Drops | One drop, three times daily to the study eye for 28 days 0.1% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days |
| FG002 | 0.3% AG-86893 Eye Drops | One drop, three times daily to the study eye for 28 days 0.3% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle Eye Drops | One drop, three times daily to the study eye for 28 days Vehicle Eye Drops: One drop, three times daily to the study eye for 28 days |
| BG001 | 0.1% AG-86893 Eye Drops |
| 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 | Change From Baseline in Overall Conjunctival Hyperemia Score | Assessed by digital ocular photography; each quadrant of the eye (superior, inferior, nasal, temporal) will be scored using a 5-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe) and graded by a reading center. The overall conjunctival score is the average of the four quadrants. Assessments are made by subtracting the score at Baseline from the score on Day 28. An increase in value indicates worsening of hyperemia, while a decrease indicates improvement. | modified intent-to-treat (mITT) | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Day 28 |
|
Adverse events were monitored for each patient until Day 84 (exit).
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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 | Vehicle Eye Drops | One drop, three times daily to the study eye for 28 days Vehicle Eye Drops: One drop, three times daily to the study eye for 28 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Discoloration | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tan Nguyen | Allgenesis Biotherapeutics | +886-2-8787-1232 | tan.nguyen@allgenesis.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 5, 2019 | Aug 17, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 20, 2019 | Nov 4, 2020 | Prot_002.pdf |
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| ID | Term |
|---|---|
| D011625 | Pterygium |
| D006940 | Hyperemia |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 0.3% AG-86893 Eye Drops | Drug | One drop, three times daily to the study eye for 28 days |
|
| Vehicle Eye Drops | Drug | One drop, three times daily to the study eye for 28 days |
|
| Baseline and Day 28 |
| Sippy Downs |
| Queensland |
| Australia |
| Bendigo Eye Clinic | Bendigo | Victoria | Australia |
| Essendon Eye Clinic | Essendon | Victoria | Australia |
| The Geelong Eye Centre | Waurn Ponds | Victoria | Australia |
| Lions Eye Institute | Nedlands | Western Australia | Australia |
One drop, three times daily to the study eye for 28 days
0.1% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days
| BG002 | 0.3% AG-86893 Eye Drops | One drop, three times daily to the study eye for 28 days 0.3% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 0.1% AG-86893 Eye Drops | One drop, three times daily to the study eye for 28 days 0.1% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days |
| OG002 | 0.3% AG-86893 Eye Drops | One drop, three times daily to the study eye for 28 days 0.3% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days |
|
|
|
| Secondary | Change From Baseline in Conjunctival Hyperemia Score in the Quadrant With the Pterygium | Assessed by digital ocular photography; the quadrant with the pterygium will be scored using a 5-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe) and graded by a reading center. Assessments are made by subtracting the score at Baseline from the score on Day 28. An increase in value indicates worsening of hyperemia, while a decrease indicates improvement. | Per protocol (PP) | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Day 28 |
|
|
|
|
| Post-Hoc | Percent of Patients With a 1-point Decrease in Hyperemia Score in the Quadrant With the Pterygium | Assessed by digital ocular photography; the quadrant with the pterygium will be scored using a 5-point scale and graded by a reading center. A 1-point reduction in hyperemia score is considered clinically meaningful. | Per protocol (PP) | Posted | Count of Participants | Participants | Day 28 |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 5 |
| 20 |
| EG001 | 0.1% AG-86893 Eye Drops | One drop, three times daily to the study eye for 28 days 0.1% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days | 0 | 22 | 0 | 22 | 5 | 22 |
| EG002 | 0.3% AG-86893 Eye Drops | One drop, three times daily to the study eye for 28 days 0.3% AG-86893 Eye Drops: One drop, three times daily to the study eye for 28 days | 0 | 22 | 0 | 22 | 15 | 22 |
| Vision blurred | Eye disorders | MedDRA (21.1) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (21.1) | Systematic Assessment |
|
| Eye pruritis | Eye disorders | MedDRA (21.1) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (21.1) | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA (21.1) | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA (21.1) | Systematic Assessment |
|
| Episcleritis | Eye disorders | MedDRA (21.1) | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (21.1) | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA (21.1) | Systematic Assessment |
|
| Influenza | Ear and labyrinth disorders | MedDRA (21.1) | Systematic Assessment |
|
| Nasopharyngitis | Ear and labyrinth disorders | MedDRA (21.1) | Systematic Assessment |
|
| Pneumonia | Ear and labyrinth disorders | MedDRA (21.1) | Systematic Assessment |
|
| Viral upper respiratory tract infection | Ear and labyrinth disorders | MedDRA (21.1) | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
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| Superiority |
| Superiority |