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This is a Phase 2a, 2-part study (designated Parts A and B) that will evaluate APP13007 dose strength and dosing frequency in a randomized double-masked fashion for comparison to the respective matching vehicle placebo. Part A will be conducted first to evaluate 0.05% APP13007 and matching vehicle placebo in an approximate 1:1 ratio in approximately 42 subjects who experience postoperative inflammation on the first day following routine, uncomplicated, cataract surgery and who meet all eligibility criteria. Based on the results of Part A, Part B of the study may be open for enrollment to evaluate 0.05% and/or 0.1% APP13007 at various dosing frequency in approximately 84 subjects, also in an approximate 1:1 ratio, active vs. placebo. In each Part, subjects will return periodically for study assessments during the treatment period and then for a follow-up visit approximately 1 week after stopping the study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APP13007 0.05% twice daily (BID) [Part A] | Experimental | 1 drop 0.05% APP13007 twice daily for 21 days to the operated eye |
|
| APP13007 0.05% Placebo twice daily (BID) [Part A] | Experimental | 1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye |
|
| APP13007 0.05% twice daily (BID) and once daily (QD) [Part B] | Experimental | 1 drop 0.05% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye |
|
| APP13007 0.05% Placebo twice daily (BID) and once daily (QD) [Part B] | Experimental | 1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye |
|
| APP13007 0.1% twice daily (BID) and once daily (QD) [Part B] | Experimental | 1 drop 0.1% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APP13007, 0.05% | Drug | APP13007 eye drop, 0.05% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Emergent Adverse Events | Number of treatment emergent adverse events and number of participants. | From First dose to Post-operative Day 28 (Part A) or Day 22 (Part B) |
| Intraocular Pressure - Change From Baseline (POD1 Prior to Dosing) to End-of-Treatment in the Operated Study Eye | Intraocular pressure is measured in mm Hg at each study visit with a Goldmann applanation tonometer. The change from baseline is calculated by subtracting the pretreatment measurement value from the value at each visit. | Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B) |
| Absolute Anterior Chamber Cell Count - Change From Baseline (POD1 Prior to Dosing) to POD 15 in the Operated Study Eye | The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area. | Baseline and Post-operative Day 15 |
| Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye | The visual acuity in each eye is corrected using the pinhole method and the acuity is quantified on a logMAR (minimal angle of resolution) scale using the 'Early Treatment Diabetic Retinopathy Study' [ETDRS] charts for right and left eyes. A logMAR Score is calculated using the number of incorrect letters. | Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B) |
| Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD15 in the Operated Study Eye | Ocular pain is measured in each eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain). | Baseline and Post-operative Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects With Anterior Chamber Cell Count = 0 at POD15 in the Operated Study Eye Without Rescue Medication | The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area. | Post-operative Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | AimMax Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornea and Cataract Consultants of Arizona | Phoenix | Arizona | 85032 | United States | ||
| United Medical Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41329923 | Derived | Levenson J, Walters TR, Martel J, Wang L, Nunez DJ. Dose-selection study of clobetasol propionate ophthalmic suspension that evaluated inflammation and pain after cataract surgery. J Cataract Refract Surg. 2026 May 1;52(5):444-451. doi: 10.1097/j.jcrs.0000000000001845. |
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Of 52 enrolled participants for Part A, 45 met inclusion criteria and were randomized to treatment. Of 113 enrolled participants for Part B, 87 met inclusion criteria and were randomized to treatment.
A multi-center US study in which 9 sites recruited subjects between August 2019 and October 2019 for Study Part A and between November 2019 and February 2020 for Study Part B
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| ID | Title | Description |
|---|---|---|
| FG000 | APP13007 0.05% Twice Daily (BID) | 1 drop 0.05% APP13007 twice daily for 21 days to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05% |
| FG001 | APP13007 0.05% Placebo Twice Daily (BID) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 15, 2019 | May 3, 2023 |
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| APP13007 0.1% Placebo twice daily (BID) and once daily (QD) [Part B] | Experimental | 1 drop matching vehicle placebo for 0.1% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye |
|
| APP13007, 0.1% | Drug | APP13007 eye drop, 0.1% |
|
| APP13007 Placebo, 0.05% | Drug | APP13007 placebo eyedrop, 0.05% |
|
| APP13007 Placebo, 0.1% | Drug | APP13007 placebo eyedrop, 0.1% |
|
| Subjects With Ocular Pain Grade = 0 at POD 15 in the Operated Study Eye Without Rescue Medication |
Ocular pain is measured in each eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain). |
| Post-operative Day 15 |
| Anterior Chamber Flare - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye | The degree of turbidity (flare) in the anterior chamber of the eye is measured using slit-lamp biomicroscopy and quantified on a five-point (0-4) anterior chamber flare grade scale (0 = none; 4 = Intense). The change from baseline is calculated by subtracting the pretreatment measurement value from the value at each visit. | Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B) |
| Subjects Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment | Subjects who do not respond to study treatment after randomization (anterior chamber cell count > 30 cells or an increase in anterior chamber cell count by > 15 cells from pre-dose baseline or ≥ 2 grade of increase in anterior chamber flare from pre-dose baseline) are started on anti-inflammatory medication (referred to as 'Rescue' medication). The number of subjects starting 'Rescue' medication is recorded at each study visit. | First dose to Post-operative Day 22 (Part A) or Day 15 (Part B) |
| Inglewood |
| California |
| 90301 |
| United States |
| Martel Eye Medical Group | Rancho Cordova | California | 95670 | United States |
| Levenson Eye Associates | Jacksonville | Florida | 32204 | United States |
| Bowden Eye and Associates | Jacksonville | Florida | 32256 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| Eye Care Specialists | Kingston | Pennsylvania | 18704 | United States |
| Keystone Research Ltd. | Austin | Texas | 78731 | United States |
| Cataract & Glaucoma Center | El Paso | Texas | 79902 | United States |
1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye
APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05%
| FG002 | APP13007 0.05% Twice Daily (BID) and Once Daily (QD) | 1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05% |
| FG003 | APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) | 1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05% |
| FG004 | APP13007 0.1% Twice Daily (BID) and Once Daily (QD) | 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1% |
| FG005 | APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) | 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1% |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-Treat Population
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| ID | Title | Description |
|---|---|---|
| BG000 | APP13007 0.05% Twice Daily (BID) | 1 drop 0.05% APP13007 twice daily for 21 days to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05% |
| BG001 | APP13007 0.05% Placebo Twice Daily (BID) | 1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05% |
| BG002 | APP13007 0.05% Twice Daily (BID) and Once Daily (QD) | 1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05% |
| BG003 | APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) | 1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05% |
| BG004 | APP13007 0.1% Twice Daily (BID) and Once Daily (QD) | 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1% |
| BG005 | APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) | 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1% |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Number of Treatment Emergent Adverse Events | Number of treatment emergent adverse events and number of participants. | Safety Population | Posted | Count of Participants | Participants | From First dose to Post-operative Day 28 (Part A) or Day 22 (Part B) |
|
|
| |||||||||||||||||||||||||||||||||||||||||
| Primary | Intraocular Pressure - Change From Baseline (POD1 Prior to Dosing) to End-of-Treatment in the Operated Study Eye | Intraocular pressure is measured in mm Hg at each study visit with a Goldmann applanation tonometer. The change from baseline is calculated by subtracting the pretreatment measurement value from the value at each visit. | Safety Population - Participants who had the IOP data at End of Treatment | Posted | Mean | Standard Deviation | mmHg | Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B) |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Absolute Anterior Chamber Cell Count - Change From Baseline (POD1 Prior to Dosing) to POD 15 in the Operated Study Eye | The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area. | Intent to Treat Population. Last observation carried forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | cells/mm^2 | Baseline and Post-operative Day 15 |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye | The visual acuity in each eye is corrected using the pinhole method and the acuity is quantified on a logMAR (minimal angle of resolution) scale using the 'Early Treatment Diabetic Retinopathy Study' [ETDRS] charts for right and left eyes. A logMAR Score is calculated using the number of incorrect letters. | Intent to Treat Population. Last observation carried forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | logMAR score | Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B) |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD15 in the Operated Study Eye | Ocular pain is measured in each eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain). | Intent to Treat Population. Last observation carried forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | grade | Baseline and Post-operative Day 15 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Subjects With Anterior Chamber Cell Count = 0 at POD15 in the Operated Study Eye Without Rescue Medication | The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area. | Intent to Treat Population. Last observation carried forward (LOCF) imputation method. | Posted | Count of Participants | Participants | Post-operative Day 15 |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Subjects With Ocular Pain Grade = 0 at POD 15 in the Operated Study Eye Without Rescue Medication | Ocular pain is measured in each eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain). | Intent to Treat Population. Last observation carried forward (LOCF) imputation method. | Posted | Count of Participants | Participants | Post-operative Day 15 |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Anterior Chamber Flare - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye | The degree of turbidity (flare) in the anterior chamber of the eye is measured using slit-lamp biomicroscopy and quantified on a five-point (0-4) anterior chamber flare grade scale (0 = none; 4 = Intense). The change from baseline is calculated by subtracting the pretreatment measurement value from the value at each visit. | Intent to Treat Population. Last observation carried forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | grade | Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B) |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Subjects Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment | Subjects who do not respond to study treatment after randomization (anterior chamber cell count > 30 cells or an increase in anterior chamber cell count by > 15 cells from pre-dose baseline or ≥ 2 grade of increase in anterior chamber flare from pre-dose baseline) are started on anti-inflammatory medication (referred to as 'Rescue' medication). The number of subjects starting 'Rescue' medication is recorded at each study visit. | Intent to Treat Population | Posted | Count of Participants | Participants | First dose to Post-operative Day 22 (Part A) or Day 15 (Part B) |
|
Serious adverse events were collected from informed consent through Post-operative Day 28 for Study Part A and informed consent through Post-operative Day 22 for Study Part B. Other (not Including Serious) adverse events were collected from the first dose through Post-operative Day 28 for Study Part A; from the first dose through Post-operative Day 22 for Study Part B.
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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 | APP13007 0.05% Twice Daily (BID) | 1 drop 0.05% APP13007 twice daily for 21 days to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05% | 0 | 22 | 0 | 22 | 2 | 22 |
| EG001 | APP13007 0.05% Placebo Twice Daily (BID) | 1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05% | 0 | 23 | 0 | 23 | 6 | 23 |
| EG002 | APP13007 0.05% Twice Daily (BID) and Once Daily (QD) | 1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.05%: APP13007 eye drop, 0.05% | 0 | 22 | 0 | 22 | 2 | 22 |
| EG003 | APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) | 1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05% | 0 | 22 | 0 | 22 | 5 | 22 |
| EG004 | APP13007 0.1% Twice Daily (BID) and Once Daily (QD) | 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1% | 0 | 22 | 0 | 22 | 1 | 22 |
| EG005 | APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) | 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1% | 0 | 21 | 0 | 21 | 2 | 21 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye inflammation | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 22.0 | Systematic Assessment |
|
Exploratory Phase 2 study with small sample sizes
The Institutions and Investigators participating in this trial shall have no right to publish or present the results of this study without the prior written consent of the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | AimMax Therapeutics Inc. | 919-797-1146 | admin@aimmaxrx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 4, 2020 | May 3, 2023 | SAP_001.pdf |
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) |
1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05% |
| OG004 | APP13007 0.1% Twice Daily (BID) and Once Daily (QD) | 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1% |
| OG005 | APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) | 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1% |
|
|
1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05% |
| OG004 | APP13007 0.1% Twice Daily (BID) and Once Daily (QD) | 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1% |
| OG005 | APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) | 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1% |
|
|
| OG003 | APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) | 1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05% |
| OG004 | APP13007 0.1% Twice Daily (BID) and Once Daily (QD) | 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1% |
| OG005 | APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) | 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1% |
|
|
1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05% |
| OG004 | APP13007 0.1% Twice Daily (BID) and Once Daily (QD) | 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1% |
| OG005 | APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) | 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1% |
|
|
1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05% |
| OG004 | APP13007 0.1% Twice Daily (BID) and Once Daily (QD) | 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1% |
| OG005 | APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) | 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1% |
|
|
1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05% |
| OG004 | APP13007 0.1% Twice Daily (BID) and Once Daily (QD) | 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1% |
| OG005 | APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) | 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1% |
|
|
| OG003 | APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) | 1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05% |
| OG004 | APP13007 0.1% Twice Daily (BID) and Once Daily (QD) | 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1% |
| OG005 | APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) | 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1% |
|
|
| OG003 | APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) | 1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.05%: APP13007 placebo eyedrop, 0.05% |
| OG004 | APP13007 0.1% Twice Daily (BID) and Once Daily (QD) | 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007, 0.1%: APP13007 eye drop, 0.1% |
| OG005 | APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) | 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye APP13007 Placebo, 0.1%: APP13007 placebo eyedrop, 0.1% |
|
|