Ocular Inflammation and Pain After Cataract Surgery
Conditions
Brief summary
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.
Interventions
DRUGAPP13007 Placebo, 0.05%
APP13007 placebo eyedrop, 0.05%
DRUGAPP13007 Placebo, 0.1%
APP13007 placebo eyedrop, 0.1%
DRUGAPP13007, 0.05%
APP13007 eye drop, 0.05%
DRUGAPP13007, 0.1%
APP13007 eye drop, 0.1%
Sponsors
Formosa Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye. * In Investigator's opinion, have Early Treatment Diabetic Retinopathy Study estimated potential of 0.7 (20/100) or better in study eye. * Have \> 10 and ≤ 30 cells in anterior chamber. * Have an intraocular pressure ≤ 30 mmHg.
Exclusion criteria
* Have an anterior chamber cell count \> 0 or any evidence of intraocular inflammation. * Have a score \> 0 on Ocular Pain Assessment in either eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD15 in the Operated Study Eye | Baseline and Post-operative Day 15 | 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). |
| Number of Treatment Emergent Adverse Events | From First dose to Post-operative Day 28 (Part A) or Day 22 (Part B) | Number of treatment emergent adverse events and number of participants. |
| Intraocular Pressure - Change From Baseline (POD1 Prior to Dosing) to End-of-Treatment in the Operated Study Eye | Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B) | 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. |
| Absolute Anterior Chamber Cell Count - Change From Baseline (POD1 Prior to Dosing) to POD 15 in the Operated Study Eye | Baseline and Post-operative Day 15 | 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. |
| Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye | Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjects With Ocular Pain Grade = 0 at POD 15 in the Operated Study Eye Without Rescue Medication | Post-operative Day 15 | 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). |
| Anterior Chamber Flare - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye | Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B) | 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. |
| Subjects Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment | First dose to Post-operative Day 22 (Part A) or Day 15 (Part B) | 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. |
| Subjects With Anterior Chamber Cell Count = 0 at POD15 in the Operated Study Eye Without Rescue Medication | Post-operative Day 15 | 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. |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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% | 22 |
| 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% | 23 |
| 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% | 22 |
| 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% | 22 |
| 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% | 22 |
| 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% | 21 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 | 1 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 3 | 0 | 0 | 0 | 0 |
| Overall Study | Rescue therapy, prohibited medication, withdrawn requiring alternate medication for inflammation | 0 | 3 | 0 | 5 | 1 | 6 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | APP13007 0.05% Twice Daily (BID) | Total | APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) | APP13007 0.1% Twice Daily (BID) and Once Daily (QD) | APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) | APP13007 0.05% Twice Daily (BID) and Once Daily (QD) | APP13007 0.05% Placebo Twice Daily (BID) |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 69.1 years STANDARD_DEVIATION 8.6 | 67.9 years STANDARD_DEVIATION 6.7 | 65.2 years STANDARD_DEVIATION 6.3 | 70.0 years STANDARD_DEVIATION 6 | 70.0 years STANDARD_DEVIATION 5 | 66.8 years STANDARD_DEVIATION 6.6 | 66.3 years STANDARD_DEVIATION 6.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 18 Participants | 3 Participants | 2 Participants | 2 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 114 Participants | 18 Participants | 20 Participants | 20 Participants | 19 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 11 Participants | 1 Participants | 3 Participants | 2 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 20 Participants | 2 Participants | 2 Participants | 2 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 101 Participants | 18 Participants | 17 Participants | 18 Participants | 15 Participants | 18 Participants |
| Region of Enrollment United States | 22 Participants | 132 Participants | 21 Participants | 22 Participants | 22 Participants | 22 Participants | 23 Participants |
| Sex: Female, Male Female | 17 Participants | 87 Participants | 9 Participants | 16 Participants | 14 Participants | 16 Participants | 15 Participants |
| Sex: Female, Male Male | 5 Participants | 45 Participants | 12 Participants | 6 Participants | 8 Participants | 6 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 23 | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 21 |
| other Total, other adverse events | 2 / 22 | 6 / 23 | 2 / 22 | 5 / 22 | 1 / 22 | 2 / 21 |
| serious Total, serious adverse events | 0 / 22 | 0 / 23 | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 21 |
Outcome results
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.
Time frame: Baseline and Post-operative Day 15
Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APP13007 0.05% Twice Daily (BID) | Absolute Anterior Chamber Cell Count - Change From Baseline (POD1 Prior to Dosing) to POD 15 in the Operated Study Eye | -16.64 cells/mm^2 | Standard Deviation 5.8 |
| APP13007 0.05% Placebo Twice Daily (BID) | Absolute Anterior Chamber Cell Count - Change From Baseline (POD1 Prior to Dosing) to POD 15 in the Operated Study Eye | -9.24 cells/mm^2 | Standard Deviation 10.34 |
| APP13007 0.05% Twice Daily (BID) and Once Daily (QD) | Absolute Anterior Chamber Cell Count - Change From Baseline (POD1 Prior to Dosing) to POD 15 in the Operated Study Eye | -11.48 cells/mm^2 | Standard Deviation 8.65 |
| APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) | Absolute Anterior Chamber Cell Count - Change From Baseline (POD1 Prior to Dosing) to POD 15 in the Operated Study Eye | -5.67 cells/mm^2 | Standard Deviation 11.73 |
| APP13007 0.1% Twice Daily (BID) and Once Daily (QD) | Absolute Anterior Chamber Cell Count - Change From Baseline (POD1 Prior to Dosing) to POD 15 in the Operated Study Eye | -11.90 cells/mm^2 | Standard Deviation 4.73 |
| APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) | Absolute Anterior Chamber Cell Count - Change From Baseline (POD1 Prior to Dosing) to POD 15 in the Operated Study Eye | -7.43 cells/mm^2 | Standard Deviation 11.15 |
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.
Time frame: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)
Population: Safety Population - Participants who had the IOP data at End of Treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APP13007 0.05% Twice Daily (BID) | Intraocular Pressure - Change From Baseline (POD1 Prior to Dosing) to End-of-Treatment in the Operated Study Eye | 1.1 mmHg | Standard Deviation 4.2 |
| APP13007 0.05% Placebo Twice Daily (BID) | Intraocular Pressure - Change From Baseline (POD1 Prior to Dosing) to End-of-Treatment in the Operated Study Eye | -2.3 mmHg | Standard Deviation 4 |
| APP13007 0.05% Twice Daily (BID) and Once Daily (QD) | Intraocular Pressure - Change From Baseline (POD1 Prior to Dosing) to End-of-Treatment in the Operated Study Eye | -2.37 mmHg | Standard Deviation 3.71 |
| APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) | Intraocular Pressure - Change From Baseline (POD1 Prior to Dosing) to End-of-Treatment in the Operated Study Eye | -2.38 mmHg | Standard Deviation 3.14 |
| APP13007 0.1% Twice Daily (BID) and Once Daily (QD) | Intraocular Pressure - Change From Baseline (POD1 Prior to Dosing) to End-of-Treatment in the Operated Study Eye | -1.28 mmHg | Standard Deviation 4.36 |
| APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) | Intraocular Pressure - Change From Baseline (POD1 Prior to Dosing) to End-of-Treatment in the Operated Study Eye | -1.00 mmHg | Standard Deviation 2.3 |
Primary
Number of Treatment Emergent Adverse Events
Number of treatment emergent adverse events and number of participants.
Time frame: From First dose to Post-operative Day 28 (Part A) or Day 22 (Part B)
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| APP13007 0.05% Twice Daily (BID) | Number of Treatment Emergent Adverse Events | 4 Participants |
| APP13007 0.05% Placebo Twice Daily (BID) | Number of Treatment Emergent Adverse Events | 7 Participants |
| APP13007 0.05% Twice Daily (BID) and Once Daily (QD) | Number of Treatment Emergent Adverse Events | 3 Participants |
| APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) | Number of Treatment Emergent Adverse Events | 8 Participants |
| APP13007 0.1% Twice Daily (BID) and Once Daily (QD) | Number of Treatment Emergent Adverse Events | 6 Participants |
| APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) | Number of Treatment Emergent Adverse Events | 3 Participants |
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).
Time frame: Baseline and Post-operative Day 15
Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APP13007 0.05% Twice Daily (BID) | Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD15 in the Operated Study Eye | -0.8 grade | Standard Deviation 1 |
| APP13007 0.05% Placebo Twice Daily (BID) | Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD15 in the Operated Study Eye | -0.4 grade | Standard Deviation 1.1 |
| APP13007 0.05% Twice Daily (BID) and Once Daily (QD) | Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD15 in the Operated Study Eye | -1.1 grade | Standard Deviation 1 |
| APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) | Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD15 in the Operated Study Eye | -0.4 grade | Standard Deviation 2 |
| APP13007 0.1% Twice Daily (BID) and Once Daily (QD) | Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD15 in the Operated Study Eye | -0.6 grade | Standard Deviation 1.2 |
| APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) | Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD15 in the Operated Study Eye | -0.3 grade | Standard Deviation 1.5 |
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.
Time frame: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)
Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APP13007 0.05% Twice Daily (BID) | Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye | -0.179 logMAR score | Standard Deviation 0.266 |
| APP13007 0.05% Placebo Twice Daily (BID) | Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye | -0.073 logMAR score | Standard Deviation 0.174 |
| APP13007 0.05% Twice Daily (BID) and Once Daily (QD) | Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye | -0.106 logMAR score | Standard Deviation 0.184 |
| APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) | Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye | -0.024 logMAR score | Standard Deviation 0.133 |
| APP13007 0.1% Twice Daily (BID) and Once Daily (QD) | Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye | -0.130 logMAR score | Standard Deviation 0.165 |
| APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) | Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye | -0.025 logMAR score | Standard Deviation 0.192 |
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.
Time frame: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)
Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| APP13007 0.05% Twice Daily (BID) | Anterior Chamber Flare - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye | -1.05 grade | Standard Deviation 0.58 |
| APP13007 0.05% Placebo Twice Daily (BID) | Anterior Chamber Flare - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye | -0.39 grade | Standard Deviation 0.94 |
| APP13007 0.05% Twice Daily (BID) and Once Daily (QD) | Anterior Chamber Flare - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye | -0.77 grade | Standard Deviation 0.81 |
| APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) | Anterior Chamber Flare - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye | -0.48 grade | Standard Deviation 0.96 |
| APP13007 0.1% Twice Daily (BID) and Once Daily (QD) | Anterior Chamber Flare - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye | -0.64 grade | Standard Deviation 0.49 |
| APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) | Anterior Chamber Flare - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye | -0.10 grade | Standard Deviation 1.04 |
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.
Time frame: First dose to Post-operative Day 22 (Part A) or Day 15 (Part B)
Population: Intent to Treat Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| APP13007 0.05% Twice Daily (BID) | Subjects Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment | 0 Participants |
| APP13007 0.05% Placebo Twice Daily (BID) | Subjects Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment | 3 Participants |
| APP13007 0.05% Twice Daily (BID) and Once Daily (QD) | Subjects Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment | 0 Participants |
| APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) | Subjects Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment | 5 Participants |
| APP13007 0.1% Twice Daily (BID) and Once Daily (QD) | Subjects Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment | 0 Participants |
| APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) | Subjects Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment | 5 Participants |
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.
Time frame: Post-operative Day 15
Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| APP13007 0.05% Twice Daily (BID) | Subjects With Anterior Chamber Cell Count = 0 at POD15 in the Operated Study Eye Without Rescue Medication | 15 Participants |
| APP13007 0.05% Placebo Twice Daily (BID) | Subjects With Anterior Chamber Cell Count = 0 at POD15 in the Operated Study Eye Without Rescue Medication | 8 Participants |
| APP13007 0.05% Twice Daily (BID) and Once Daily (QD) | Subjects With Anterior Chamber Cell Count = 0 at POD15 in the Operated Study Eye Without Rescue Medication | 10 Participants |
| APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) | Subjects With Anterior Chamber Cell Count = 0 at POD15 in the Operated Study Eye Without Rescue Medication | 7 Participants |
| APP13007 0.1% Twice Daily (BID) and Once Daily (QD) | Subjects With Anterior Chamber Cell Count = 0 at POD15 in the Operated Study Eye Without Rescue Medication | 13 Participants |
| APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) | Subjects With Anterior Chamber Cell Count = 0 at POD15 in the Operated Study Eye Without Rescue Medication | 8 Participants |
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).
Time frame: Post-operative Day 15
Population: Intent to Treat Population. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| APP13007 0.05% Twice Daily (BID) | Subjects With Ocular Pain Grade = 0 at POD 15 in the Operated Study Eye Without Rescue Medication | 21 Participants |
| APP13007 0.05% Placebo Twice Daily (BID) | Subjects With Ocular Pain Grade = 0 at POD 15 in the Operated Study Eye Without Rescue Medication | 16 Participants |
| APP13007 0.05% Twice Daily (BID) and Once Daily (QD) | Subjects With Ocular Pain Grade = 0 at POD 15 in the Operated Study Eye Without Rescue Medication | 20 Participants |
| APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) | Subjects With Ocular Pain Grade = 0 at POD 15 in the Operated Study Eye Without Rescue Medication | 16 Participants |
| APP13007 0.1% Twice Daily (BID) and Once Daily (QD) | Subjects With Ocular Pain Grade = 0 at POD 15 in the Operated Study Eye Without Rescue Medication | 19 Participants |
| APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) | Subjects With Ocular Pain Grade = 0 at POD 15 in the Operated Study Eye Without Rescue Medication | 15 Participants |