Inflammatory Reaction Due to Ocular Lens Prosthesis
Conditions
Keywords
ocular inflammation cataract surgery, post cataract surgery inflammation
Brief summary
This study will test the efficacy and safety of IBI-10090 for the reduction of ocular inflammation after cataract surgery.
Detailed description
All patients received active treatment in this study. Dose group 1 received 114ug of dexamethasone, Dose group 2 received 513ug and Dose group 3 received 684ug.
Interventions
DRUGIBI-10090
Single intraocular injection
Sponsors
ICON Bioscience Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients 40 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation.
Exclusion criteria
* Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0. * Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to screening. * Patients with any signs of intraocular inflammation in either eye at screening. * Patients who have received any prior intravitreal injections in the study eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clearance of Anterior Chamber Cells | Day 8 post treatment | Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber cells (ACC) graded on a scale of 0 to 4. The primary efficacy endpoint was complete clearing of ACC, where grade 0 = 0 cells in the anterior chamber on POD 8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anterior Chamber Flare (ACF) Grade | Day 90 post-treatment | Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber flare (ACF) graded on a scale of 0 to 4. |
| Conjunctival Erythema Grade | Day 90 post-treatment | Conjunctival erythema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3. |
| Corneal Edema Grade | Day 90 post-treatment | Cornea edema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3. |
| Anterior Chamber Cell Grade | Day 90 post-treatment | Anterior chamber cells (ACC) grade was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 4. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dose 1 114ug dose group | 3 |
| Dose 2 513ug dose group | 2 |
| Dose 3 684ug dose group | 1 |
| Total | 6 |
Baseline characteristics
| Characteristic | Dose 1 | Dose 2 | Dose 3 | Total |
|---|---|---|---|---|
| Age, Customized <=18 years | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Customized >=65 years | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Customized Between 18 and 65 years | 3 participants | 2 participants | 1 participants | 6 participants |
| Sex/Gender, Customized Female | 0 participants | 0 participants | 0 participants | 0 participants |
| Sex/Gender, Customized Male | 0 participants | 0 participants | 0 participants | 0 participants |
| Sex/Gender, Customized Unknown | 3 participants | 2 participants | 1 participants | 6 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 3 | 1 / 2 | 1 / 1 |
| serious Total, serious adverse events | 0 / 3 | 0 / 2 | 0 / 1 |
Outcome results
Primary
Clearance of Anterior Chamber Cells
Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber cells (ACC) graded on a scale of 0 to 4. The primary efficacy endpoint was complete clearing of ACC, where grade 0 = 0 cells in the anterior chamber on POD 8.
Time frame: Day 8 post treatment
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dose 1 | Clearance of Anterior Chamber Cells | Baseline | Grade 3 (16-30 cells) | 0 Participants |
| Dose 1 | Clearance of Anterior Chamber Cells | Baseline | Grade 0 (absent) | 3 Participants |
| Dose 1 | Clearance of Anterior Chamber Cells | POD 8 | Grade 4 (hypopyon) | 0 Participants |
| Dose 1 | Clearance of Anterior Chamber Cells | Baseline | Grade 1 (1-5 cells) | 0 Participants |
| Dose 1 | Clearance of Anterior Chamber Cells | Baseline | Grade 2 (6-15 cells) | 0 Participants |
| Dose 1 | Clearance of Anterior Chamber Cells | POD 8 | Grade 1 (1-5 cells) | 1 Participants |
| Dose 1 | Clearance of Anterior Chamber Cells | POD 8 | Grade 2 (6-15 cells) | 1 Participants |
| Dose 1 | Clearance of Anterior Chamber Cells | Baseline | Grade 4 (hypopyon) | 0 Participants |
| Dose 1 | Clearance of Anterior Chamber Cells | POD 8 | Grade 0 (absent) | 0 Participants |
| Dose 1 | Clearance of Anterior Chamber Cells | POD 8 | Grade 3 (16-30 cells) | 1 Participants |
| Dose 2 | Clearance of Anterior Chamber Cells | Baseline | Grade 2 (6-15 cells) | 0 Participants |
| Dose 2 | Clearance of Anterior Chamber Cells | Baseline | Grade 1 (1-5 cells) | 0 Participants |
| Dose 2 | Clearance of Anterior Chamber Cells | Baseline | Grade 4 (hypopyon) | 0 Participants |
| Dose 2 | Clearance of Anterior Chamber Cells | POD 8 | Grade 2 (6-15 cells) | 1 Participants |
| Dose 2 | Clearance of Anterior Chamber Cells | Baseline | Grade 0 (absent) | 2 Participants |
| Dose 2 | Clearance of Anterior Chamber Cells | Baseline | Grade 3 (16-30 cells) | 0 Participants |
| Dose 2 | Clearance of Anterior Chamber Cells | POD 8 | Grade 0 (absent) | 0 Participants |
| Dose 2 | Clearance of Anterior Chamber Cells | POD 8 | Grade 1 (1-5 cells) | 0 Participants |
| Dose 2 | Clearance of Anterior Chamber Cells | POD 8 | Grade 3 (16-30 cells) | 1 Participants |
| Dose 2 | Clearance of Anterior Chamber Cells | POD 8 | Grade 4 (hypopyon) | 0 Participants |
| Dose 3 | Clearance of Anterior Chamber Cells | Baseline | Grade 4 (hypopyon) | 0 Participants |
| Dose 3 | Clearance of Anterior Chamber Cells | POD 8 | Grade 2 (6-15 cells) | 0 Participants |
| Dose 3 | Clearance of Anterior Chamber Cells | POD 8 | Grade 3 (16-30 cells) | 0 Participants |
| Dose 3 | Clearance of Anterior Chamber Cells | POD 8 | Grade 1 (1-5 cells) | 0 Participants |
| Dose 3 | Clearance of Anterior Chamber Cells | Baseline | Grade 1 (1-5 cells) | 0 Participants |
| Dose 3 | Clearance of Anterior Chamber Cells | Baseline | Grade 0 (absent) | 1 Participants |
| Dose 3 | Clearance of Anterior Chamber Cells | Baseline | Grade 2 (6-15 cells) | 0 Participants |
| Dose 3 | Clearance of Anterior Chamber Cells | POD 8 | Grade 0 (absent) | 1 Participants |
| Dose 3 | Clearance of Anterior Chamber Cells | POD 8 | Grade 4 (hypopyon) | 0 Participants |
| Dose 3 | Clearance of Anterior Chamber Cells | Baseline | Grade 3 (16-30 cells) | 0 Participants |
Secondary
Anterior Chamber Cell Grade
Anterior chamber cells (ACC) grade was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 4.
Time frame: Day 90 post-treatment
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dose 1 | Anterior Chamber Cell Grade | POD 8 | Grade 4 (hypopyon) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 8 | Grade 0 (absent) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | Baseline | Grade 4 (hypopyon) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 30 | Grade 1 (1-5 cells) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 3 | Grade 4 (hypopyon) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 1 | Grade 0 (absent) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 30 | Grade 4 (hypopyon) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 3 | Grade 3 (16-30 cells) | 1 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 1 | Grade 1 (1-5 cells) | 1 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 8 | Grade 1 (1-5 cells) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 3 | Grade 2 (6-15 cells) | 2 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 1 | Grade 2 (6-15 cells) | 2 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 30 | Grade 2 (6-15 cells) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 3 | Grade 1 (1-5 cells) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 1 | Grade 3 (16-30 cells) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 30 | Grade 0 (absent) | 3 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 3 | Grade 0 (absent) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 1 | Grade 4 (hypopyon) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 90 | Grade 2 (6-15 cells) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 90 | Grade 1 (1-5 cells) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 15 | Grade 4 (hypopyon) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 90 | Grade 3 (16-30 cells) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 8 | Grade 3 (16-30 cells) | 1 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 15 | Grade 3 (16-30 cells) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 90 | Grade 4 (hypopyon) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | Baseline | Grade 3 (16-30 cells) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 15 | Grade 2 (6-15 cells) | 2 Participants |
| Dose 1 | Anterior Chamber Cell Grade | Baseline | Grade 0 (absent) | 3 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 90 | Grade 0 (absent) | 3 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 15 | Grade 1 (1-5 cells) | 1 Participants |
| Dose 1 | Anterior Chamber Cell Grade | Baseline | Grade 1 (1-5 cells) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 8 | Grade 2 (6-15 cells) | 2 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 15 | Grade 0 (absent) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | Baseline | Grade 2 (6-15 cells) | 0 Participants |
| Dose 1 | Anterior Chamber Cell Grade | POD 30 | Grade 3 (16-30 cells) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 90 | Grade 1 (1-5 cells) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | Baseline | Grade 3 (16-30 cells) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 8 | Grade 1 (1-5 cells) | 1 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 8 | Grade 2 (6-15 cells) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 8 | Grade 3 (16-30 cells) | 1 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 30 | Grade 0 (absent) | 1 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 30 | Grade 4 (hypopyon) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 90 | Grade 2 (6-15 cells) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 90 | Grade 3 (16-30 cells) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 90 | Grade 4 (hypopyon) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | Baseline | Grade 0 (absent) | 2 Participants |
| Dose 2 | Anterior Chamber Cell Grade | Baseline | Grade 1 (1-5 cells) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | Baseline | Grade 2 (6-15 cells) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | Baseline | Grade 4 (hypopyon) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 1 | Grade 0 (absent) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 1 | Grade 1 (1-5 cells) | 1 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 1 | Grade 2 (6-15 cells) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 1 | Grade 3 (16-30 cells) | 1 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 1 | Grade 4 (hypopyon) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 3 | Grade 0 (absent) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 3 | Grade 1 (1-5 cells) | 1 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 3 | Grade 2 (6-15 cells) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 3 | Grade 3 (16-30 cells) | 1 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 3 | Grade 4 (hypopyon) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 8 | Grade 0 (absent) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 8 | Grade 4 (hypopyon) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 15 | Grade 0 (absent) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 15 | Grade 1 (1-5 cells) | 2 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 15 | Grade 2 (6-15 cells) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 15 | Grade 3 (16-30 cells) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 15 | Grade 4 (hypopyon) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 30 | Grade 1 (1-5 cells) | 1 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 30 | Grade 2 (6-15 cells) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 30 | Grade 3 (16-30 cells) | 0 Participants |
| Dose 2 | Anterior Chamber Cell Grade | POD 90 | Grade 0 (absent) | 2 Participants |
| Dose 3 | Anterior Chamber Cell Grade | Baseline | Grade 3 (16-30 cells) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 30 | Grade 4 (hypopyon) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 8 | Grade 0 (absent) | 1 Participants |
| Dose 3 | Anterior Chamber Cell Grade | Baseline | Grade 2 (6-15 cells) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 90 | Grade 0 (absent) | 1 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 8 | Grade 4 (hypopyon) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | Baseline | Grade 1 (1-5 cells) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 30 | Grade 2 (6-15 cells) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 15 | Grade 0 (absent) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | Baseline | Grade 0 (absent) | 1 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 30 | Grade 0 (absent) | 1 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 15 | Grade 1 (1-5 cells) | 1 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 90 | Grade 4 (hypopyon) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 8 | Grade 2 (6-15 cells) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 15 | Grade 2 (6-15 cells) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 90 | Grade 3 (16-30 cells) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 30 | Grade 3 (16-30 cells) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 15 | Grade 3 (16-30 cells) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 90 | Grade 2 (6-15 cells) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 1 | Grade 4 (hypopyon) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 1 | Grade 3 (16-30 cells) | 1 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 8 | Grade 3 (16-30 cells) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 3 | Grade 0 (absent) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 1 | Grade 2 (6-15 cells) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 15 | Grade 4 (hypopyon) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 3 | Grade 1 (1-5 cells) | 1 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 1 | Grade 1 (1-5 cells) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 90 | Grade 1 (1-5 cells) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 3 | Grade 2 (6-15 cells) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 1 | Grade 0 (absent) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 8 | Grade 1 (1-5 cells) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 3 | Grade 3 (16-30 cells) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | Baseline | Grade 4 (hypopyon) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 30 | Grade 1 (1-5 cells) | 0 Participants |
| Dose 3 | Anterior Chamber Cell Grade | POD 3 | Grade 4 (hypopyon) | 0 Participants |
Secondary
Anterior Chamber Flare (ACF) Grade
Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber flare (ACF) graded on a scale of 0 to 4.
Time frame: Day 90 post-treatment
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 15 | Grade 4 (strong intensity) | 0 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 3 | Grade 0 (absent) | 1 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 90 | Grade 1 (trace) | 0 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 15 | Grade 3 (moderate Intensity) | 0 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 3 | Grade 1 (trace) | 1 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | Baseline | Grade 3 (moderate Intensity) | 0 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 15 | Grade 2 (mild intensity) | 1 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 3 | Grade 2 (mild intensity) | 1 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 15 | Grade 0 (absent) | 1 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 15 | Grade 1 (trace) | 1 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 3 | Grade 3 (moderate Intensity) | 0 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 90 | Grade 3 (moderate Intensity) | 0 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 8 | Grade 4 (strong intensity) | 0 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 3 | Grade 4 (strong intensity) | 0 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | Baseline | Grade 0 (absent) | 3 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 8 | Grade 3 (moderate Intensity) | 1 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 8 | Grade 1 (trace) | 1 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 1 | Grade 0 (absent) | 1 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 8 | Grade 2 (mild intensity) | 1 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 90 | Grade 0 (absent) | 3 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | Baseline | Grade 1 (trace) | 0 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | Baseline | Grade 4 (strong intensity) | 0 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 30 | Grade 4 (strong intensity) | 0 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | Baseline | Grade 2 (mild intensity) | 0 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 90 | Grade 2 (mild intensity) | 0 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 30 | Grade 3 (moderate Intensity) | 0 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 1 | Grade 1 (trace) | 0 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 30 | Grade 2 (mild intensity) | 0 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 1 | Grade 2 (mild intensity) | 2 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 1 | Grade 4 (strong intensity) | 0 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 30 | Grade 1 (trace) | 0 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 1 | Grade 3 (moderate Intensity) | 0 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 8 | Grade 0 (absent) | 0 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 30 | Grade 0 (absent) | 3 Participants |
| Dose 1 | Anterior Chamber Flare (ACF) Grade | POD 90 | Grade 4 (strong intensity) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 90 | Grade 0 (absent) | 2 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | Baseline | Grade 3 (moderate Intensity) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | Baseline | Grade 4 (strong intensity) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 1 | Grade 0 (absent) | 1 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 8 | Grade 0 (absent) | 1 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 15 | Grade 0 (absent) | 1 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | Baseline | Grade 0 (absent) | 2 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | Baseline | Grade 1 (trace) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | Baseline | Grade 2 (mild intensity) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 1 | Grade 1 (trace) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 1 | Grade 2 (mild intensity) | 1 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 1 | Grade 3 (moderate Intensity) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 1 | Grade 4 (strong intensity) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 3 | Grade 0 (absent) | 1 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 3 | Grade 1 (trace) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 3 | Grade 2 (mild intensity) | 1 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 3 | Grade 3 (moderate Intensity) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 3 | Grade 4 (strong intensity) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 8 | Grade 1 (trace) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 8 | Grade 2 (mild intensity) | 1 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 8 | Grade 3 (moderate Intensity) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 8 | Grade 4 (strong intensity) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 15 | Grade 1 (trace) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 15 | Grade 2 (mild intensity) | 1 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 15 | Grade 3 (moderate Intensity) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 15 | Grade 4 (strong intensity) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 30 | Grade 0 (absent) | 1 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 30 | Grade 1 (trace) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 30 | Grade 2 (mild intensity) | 1 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 30 | Grade 3 (moderate Intensity) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 30 | Grade 4 (strong intensity) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 90 | Grade 1 (trace) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 90 | Grade 2 (mild intensity) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 90 | Grade 3 (moderate Intensity) | 0 Participants |
| Dose 2 | Anterior Chamber Flare (ACF) Grade | POD 90 | Grade 4 (strong intensity) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 90 | Grade 3 (moderate Intensity) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 15 | Grade 3 (moderate Intensity) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 1 | Grade 4 (strong intensity) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 90 | Grade 1 (trace) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 15 | Grade 4 (strong intensity) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 1 | Grade 3 (moderate Intensity) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 1 | Grade 0 (absent) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 30 | Grade 0 (absent) | 1 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 1 | Grade 2 (mild intensity) | 1 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | Baseline | Grade 3 (moderate Intensity) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 30 | Grade 1 (trace) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 1 | Grade 1 (trace) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 90 | Grade 2 (mild intensity) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 30 | Grade 2 (mild intensity) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | Baseline | Grade 2 (mild intensity) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | Baseline | Grade 4 (strong intensity) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 30 | Grade 3 (moderate Intensity) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | Baseline | Grade 1 (trace) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 90 | Grade 4 (strong intensity) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 8 | Grade 1 (trace) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 30 | Grade 4 (strong intensity) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 8 | Grade 2 (mild intensity) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 3 | Grade 4 (strong intensity) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | Baseline | Grade 0 (absent) | 1 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 8 | Grade 3 (moderate Intensity) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 3 | Grade 3 (moderate Intensity) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 8 | Grade 4 (strong intensity) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 15 | Grade 0 (absent) | 1 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 3 | Grade 2 (mild intensity) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 90 | Grade 0 (absent) | 1 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 15 | Grade 1 (trace) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 3 | Grade 1 (trace) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 8 | Grade 0 (absent) | 1 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 15 | Grade 2 (mild intensity) | 0 Participants |
| Dose 3 | Anterior Chamber Flare (ACF) Grade | POD 3 | Grade 0 (absent) | 1 Participants |
Secondary
Conjunctival Erythema Grade
Conjunctival erythema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.
Time frame: Day 90 post-treatment
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dose 1 | Conjunctival Erythema Grade | POD 1 | Grade 3 (bright red bulbar) | 0 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 15 | Grade 1 (pale reddish bulbar) | 1 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 1 | Grade 2 (red bulbar) | 0 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 90 | Grade 2 (red bulbar) | 0 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 15 | Grade 0 (no erythema) | 1 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 3 | Grade 0 (no erythema) | 1 Participants |
| Dose 1 | Conjunctival Erythema Grade | Baseline | Grade 0 (no erythema) | 3 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 8 | Grade 3 (bright red bulbar) | 0 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 3 | Grade 1 (pale reddish bulbar) | 1 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 8 | Grade 0 (no erythema) | 1 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 8 | Grade 2 (red bulbar) | 2 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 3 | Grade 2 (red bulbar) | 1 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 30 | Grade 3 (bright red bulbar) | 0 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 8 | Grade 1 (pale reddish bulbar) | 0 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 3 | Grade 3 (bright red bulbar) | 0 Participants |
| Dose 1 | Conjunctival Erythema Grade | Baseline | Grade 1 (pale reddish bulbar) | 0 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 90 | Grade 3 (bright red bulbar) | 0 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 30 | Grade 2 (red bulbar) | 0 Participants |
| Dose 1 | Conjunctival Erythema Grade | Baseline | Grade 2 (red bulbar) | 0 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 90 | Grade 0 (no erythema) | 3 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 30 | Grade 1 (pale reddish bulbar) | 0 Participants |
| Dose 1 | Conjunctival Erythema Grade | Baseline | Grade 3 (bright red bulbar) | 0 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 15 | Grade 3 (bright red bulbar) | 0 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 30 | Grade 0 (no erythema) | 3 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 1 | Grade 0 (no erythema) | 3 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 90 | Grade 1 (pale reddish bulbar) | 0 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 15 | Grade 2 (red bulbar) | 1 Participants |
| Dose 1 | Conjunctival Erythema Grade | POD 1 | Grade 1 (pale reddish bulbar) | 0 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 30 | Grade 3 (bright red bulbar) | 0 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 1 | Grade 3 (bright red bulbar) | 0 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 3 | Grade 3 (bright red bulbar) | 0 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 15 | Grade 2 (red bulbar) | 0 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 90 | Grade 1 (pale reddish bulbar) | 0 Participants |
| Dose 2 | Conjunctival Erythema Grade | Baseline | Grade 0 (no erythema) | 2 Participants |
| Dose 2 | Conjunctival Erythema Grade | Baseline | Grade 1 (pale reddish bulbar) | 0 Participants |
| Dose 2 | Conjunctival Erythema Grade | Baseline | Grade 2 (red bulbar) | 0 Participants |
| Dose 2 | Conjunctival Erythema Grade | Baseline | Grade 3 (bright red bulbar) | 0 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 1 | Grade 0 (no erythema) | 1 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 1 | Grade 1 (pale reddish bulbar) | 1 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 1 | Grade 2 (red bulbar) | 0 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 3 | Grade 0 (no erythema) | 2 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 3 | Grade 1 (pale reddish bulbar) | 0 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 3 | Grade 2 (red bulbar) | 0 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 8 | Grade 0 (no erythema) | 2 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 8 | Grade 1 (pale reddish bulbar) | 0 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 8 | Grade 2 (red bulbar) | 0 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 8 | Grade 3 (bright red bulbar) | 0 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 15 | Grade 0 (no erythema) | 1 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 15 | Grade 1 (pale reddish bulbar) | 1 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 15 | Grade 3 (bright red bulbar) | 0 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 30 | Grade 0 (no erythema) | 2 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 30 | Grade 1 (pale reddish bulbar) | 0 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 30 | Grade 2 (red bulbar) | 0 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 90 | Grade 0 (no erythema) | 2 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 90 | Grade 2 (red bulbar) | 0 Participants |
| Dose 2 | Conjunctival Erythema Grade | POD 90 | Grade 3 (bright red bulbar) | 0 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 15 | Grade 0 (no erythema) | 1 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 1 | Grade 1 (pale reddish bulbar) | 0 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 1 | Grade 3 (bright red bulbar) | 0 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 15 | Grade 1 (pale reddish bulbar) | 0 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 1 | Grade 0 (no erythema) | 1 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 90 | Grade 0 (no erythema) | 1 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 15 | Grade 3 (bright red bulbar) | 0 Participants |
| Dose 3 | Conjunctival Erythema Grade | Baseline | Grade 3 (bright red bulbar) | 0 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 3 | Grade 3 (bright red bulbar) | 0 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 30 | Grade 0 (no erythema) | 1 Participants |
| Dose 3 | Conjunctival Erythema Grade | Baseline | Grade 2 (red bulbar) | 0 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 90 | Grade 3 (bright red bulbar) | 0 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 30 | Grade 1 (pale reddish bulbar) | 0 Participants |
| Dose 3 | Conjunctival Erythema Grade | Baseline | Grade 1 (pale reddish bulbar) | 0 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 90 | Grade 2 (red bulbar) | 0 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 30 | Grade 2 (red bulbar) | 0 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 8 | Grade 0 (no erythema) | 1 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 3 | Grade 2 (red bulbar) | 0 Participants |
| Dose 3 | Conjunctival Erythema Grade | Baseline | Grade 0 (no erythema) | 1 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 8 | Grade 1 (pale reddish bulbar) | 0 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 3 | Grade 1 (pale reddish bulbar) | 0 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 90 | Grade 1 (pale reddish bulbar) | 0 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 8 | Grade 2 (red bulbar) | 0 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 3 | Grade 0 (no erythema) | 1 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 30 | Grade 3 (bright red bulbar) | 0 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 8 | Grade 3 (bright red bulbar) | 0 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 1 | Grade 2 (red bulbar) | 0 Participants |
| Dose 3 | Conjunctival Erythema Grade | POD 15 | Grade 2 (red bulbar) | 0 Participants |
Secondary
Corneal Edema Grade
Cornea edema was evaluated by slit lamp biomicroscopy graded on a scale of 0 to 3.
Time frame: Day 90 post-treatment
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dose 1 | Corneal Edema Grade | POD 30 | Grade 2 (moderate edema) | 0 Participants |
| Dose 1 | Corneal Edema Grade | POD 15 | Grade 1 (mild edema) | 0 Participants |
| Dose 1 | Corneal Edema Grade | POD 1 | Grade 1 (mild edema) | 0 Participants |
| Dose 1 | Corneal Edema Grade | POD 30 | Grade 3 (severe edema) | 0 Participants |
| Dose 1 | Corneal Edema Grade | POD 1 | Grade 0 (absent) | 3 Participants |
| Dose 1 | Corneal Edema Grade | POD 90 | Grade 2 (moderate edema) | 0 Participants |
| Dose 1 | Corneal Edema Grade | POD 8 | Grade 2 (moderate edema) | 0 Participants |
| Dose 1 | Corneal Edema Grade | POD 90 | Grade 1 (mild edema) | 0 Participants |
| Dose 1 | Corneal Edema Grade | Baseline | Grade 0 (absent) | 3 Participants |
| Dose 1 | Corneal Edema Grade | POD 90 | Grade 0 (absent) | 3 Participants |
| Dose 1 | Corneal Edema Grade | Baseline | Grade 3 (severe edema) | 0 Participants |
| Dose 1 | Corneal Edema Grade | Baseline | Grade 1 (mild edema) | 0 Participants |
| Dose 1 | Corneal Edema Grade | POD 15 | Grade 0 (absent) | 3 Participants |
| Dose 1 | Corneal Edema Grade | Baseline | Grade 2 (moderate edema) | 0 Participants |
| Dose 1 | Corneal Edema Grade | POD 8 | Grade 3 (severe edema) | 0 Participants |
| Dose 1 | Corneal Edema Grade | POD 8 | Grade 0 (absent) | 3 Participants |
| Dose 1 | Corneal Edema Grade | POD 15 | Grade 2 (moderate edema) | 0 Participants |
| Dose 1 | Corneal Edema Grade | POD 3 | Grade 2 (moderate edema) | 0 Participants |
| Dose 1 | Corneal Edema Grade | POD 3 | Grade 0 (absent) | 3 Participants |
| Dose 1 | Corneal Edema Grade | POD 15 | Grade 3 (severe edema) | 0 Participants |
| Dose 1 | Corneal Edema Grade | POD 3 | Grade 1 (mild edema) | 0 Participants |
| Dose 1 | Corneal Edema Grade | POD 3 | Grade 3 (severe edema) | 0 Participants |
| Dose 1 | Corneal Edema Grade | POD 30 | Grade 0 (absent) | 3 Participants |
| Dose 1 | Corneal Edema Grade | POD 8 | Grade 1 (mild edema) | 0 Participants |
| Dose 1 | Corneal Edema Grade | POD 1 | Grade 3 (severe edema) | 0 Participants |
| Dose 1 | Corneal Edema Grade | POD 30 | Grade 1 (mild edema) | 0 Participants |
| Dose 1 | Corneal Edema Grade | POD 90 | Grade 3 (severe edema) | 0 Participants |
| Dose 1 | Corneal Edema Grade | POD 1 | Grade 2 (moderate edema) | 0 Participants |
| Dose 2 | Corneal Edema Grade | POD 3 | Grade 3 (severe edema) | 0 Participants |
| Dose 2 | Corneal Edema Grade | POD 3 | Grade 0 (absent) | 1 Participants |
| Dose 2 | Corneal Edema Grade | POD 3 | Grade 1 (mild edema) | 1 Participants |
| Dose 2 | Corneal Edema Grade | POD 3 | Grade 2 (moderate edema) | 0 Participants |
| Dose 2 | Corneal Edema Grade | POD 8 | Grade 1 (mild edema) | 1 Participants |
| Dose 2 | Corneal Edema Grade | POD 8 | Grade 2 (moderate edema) | 0 Participants |
| Dose 2 | Corneal Edema Grade | POD 15 | Grade 2 (moderate edema) | 0 Participants |
| Dose 2 | Corneal Edema Grade | POD 15 | Grade 3 (severe edema) | 0 Participants |
| Dose 2 | Corneal Edema Grade | POD 30 | Grade 0 (absent) | 2 Participants |
| Dose 2 | Corneal Edema Grade | POD 30 | Grade 1 (mild edema) | 0 Participants |
| Dose 2 | Corneal Edema Grade | POD 30 | Grade 2 (moderate edema) | 0 Participants |
| Dose 2 | Corneal Edema Grade | POD 90 | Grade 2 (moderate edema) | 0 Participants |
| Dose 2 | Corneal Edema Grade | Baseline | Grade 0 (absent) | 2 Participants |
| Dose 2 | Corneal Edema Grade | Baseline | Grade 1 (mild edema) | 0 Participants |
| Dose 2 | Corneal Edema Grade | Baseline | Grade 2 (moderate edema) | 0 Participants |
| Dose 2 | Corneal Edema Grade | Baseline | Grade 3 (severe edema) | 0 Participants |
| Dose 2 | Corneal Edema Grade | POD 1 | Grade 0 (absent) | 1 Participants |
| Dose 2 | Corneal Edema Grade | POD 1 | Grade 1 (mild edema) | 1 Participants |
| Dose 2 | Corneal Edema Grade | POD 1 | Grade 2 (moderate edema) | 0 Participants |
| Dose 2 | Corneal Edema Grade | POD 90 | Grade 1 (mild edema) | 0 Participants |
| Dose 2 | Corneal Edema Grade | POD 1 | Grade 3 (severe edema) | 0 Participants |
| Dose 2 | Corneal Edema Grade | POD 8 | Grade 0 (absent) | 1 Participants |
| Dose 2 | Corneal Edema Grade | POD 8 | Grade 3 (severe edema) | 0 Participants |
| Dose 2 | Corneal Edema Grade | POD 15 | Grade 0 (absent) | 2 Participants |
| Dose 2 | Corneal Edema Grade | POD 15 | Grade 1 (mild edema) | 0 Participants |
| Dose 2 | Corneal Edema Grade | POD 30 | Grade 3 (severe edema) | 0 Participants |
| Dose 2 | Corneal Edema Grade | POD 90 | Grade 0 (absent) | 2 Participants |
| Dose 2 | Corneal Edema Grade | POD 90 | Grade 3 (severe edema) | 0 Participants |
| Dose 3 | Corneal Edema Grade | POD 1 | Grade 2 (moderate edema) | 0 Participants |
| Dose 3 | Corneal Edema Grade | POD 3 | Grade 0 (absent) | 1 Participants |
| Dose 3 | Corneal Edema Grade | POD 30 | Grade 0 (absent) | 1 Participants |
| Dose 3 | Corneal Edema Grade | POD 30 | Grade 3 (severe edema) | 0 Participants |
| Dose 3 | Corneal Edema Grade | POD 1 | Grade 3 (severe edema) | 0 Participants |
| Dose 3 | Corneal Edema Grade | POD 3 | Grade 2 (moderate edema) | 0 Participants |
| Dose 3 | Corneal Edema Grade | POD 15 | Grade 3 (severe edema) | 0 Participants |
| Dose 3 | Corneal Edema Grade | POD 15 | Grade 2 (moderate edema) | 0 Participants |
| Dose 3 | Corneal Edema Grade | POD 3 | Grade 3 (severe edema) | 0 Participants |
| Dose 3 | Corneal Edema Grade | POD 15 | Grade 1 (mild edema) | 0 Participants |
| Dose 3 | Corneal Edema Grade | POD 3 | Grade 1 (mild edema) | 0 Participants |
| Dose 3 | Corneal Edema Grade | POD 8 | Grade 0 (absent) | 1 Participants |
| Dose 3 | Corneal Edema Grade | POD 90 | Grade 3 (severe edema) | 0 Participants |
| Dose 3 | Corneal Edema Grade | POD 8 | Grade 3 (severe edema) | 0 Participants |
| Dose 3 | Corneal Edema Grade | Baseline | Grade 1 (mild edema) | 0 Participants |
| Dose 3 | Corneal Edema Grade | POD 8 | Grade 2 (moderate edema) | 0 Participants |
| Dose 3 | Corneal Edema Grade | Baseline | Grade 2 (moderate edema) | 0 Participants |
| Dose 3 | Corneal Edema Grade | Baseline | Grade 0 (absent) | 1 Participants |
| Dose 3 | Corneal Edema Grade | POD 90 | Grade 0 (absent) | 1 Participants |
| Dose 3 | Corneal Edema Grade | Baseline | Grade 3 (severe edema) | 0 Participants |
| Dose 3 | Corneal Edema Grade | POD 90 | Grade 1 (mild edema) | 0 Participants |
| Dose 3 | Corneal Edema Grade | POD 15 | Grade 0 (absent) | 1 Participants |
| Dose 3 | Corneal Edema Grade | POD 1 | Grade 0 (absent) | 0 Participants |
| Dose 3 | Corneal Edema Grade | POD 30 | Grade 2 (moderate edema) | 0 Participants |
| Dose 3 | Corneal Edema Grade | POD 8 | Grade 1 (mild edema) | 0 Participants |
| Dose 3 | Corneal Edema Grade | POD 1 | Grade 1 (mild edema) | 1 Participants |
| Dose 3 | Corneal Edema Grade | POD 30 | Grade 1 (mild edema) | 0 Participants |
| Dose 3 | Corneal Edema Grade | POD 90 | Grade 2 (moderate edema) | 0 Participants |