Glioblastoma Multiforme
Conditions
Keywords
Glioblastoma Multiforme (GBM), Cancer, Chemoradiation therapy, Epidermal growth factor receptor-amplified glioblastoma, Radiation, Temozolomide
Brief summary
The objective of this study was to evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who were being treated with depatuxizumab mafodotin (ABT-414).
Detailed description
This Phase 3b open-label, randomized, exploratory study included 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide \[RT/TMZ\]) and adjuvant therapy (TMZ). All participants received depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids; standard steroids with vasoconstrictors and cold compress; and enhanced steroids with vasoconstrictors and cold compress. The study comprised a screening period of up to 7 weeks after surgery, a 6-week concomitant Chemoradiation Phase, an Adjuvant Phase beginning approximately 4 weeks after completion of chemoradiation, and a Follow-Up Phase.
Interventions
DRUGVasoconstrictor eye drops
Solution, eye drop
OTHERCold compress
Cold compress
DRUGOphthalmic steroid ointment
Ointment
Solution, eye drop
During the Chemoradiation Phase, participants were to receive depatuxizumab mafodotin at 2.0 mg/kg IV infusion over 30 - 40 minutes once every 2 weeks (Day 1 of Weeks 1, 3, and 5 of the 6-week regimen). During the Adjuvant Therapy Phase, participants were to receive depatuxizumab mafodotin at 1.25 mg/kg on Day 1 (± 2 days) and Day 15 (± 2 days) of each 28-day cycle as a 30 - 40 minute infusion for 12 cycles.
DRUGTemozolomide
Temozolomide was to be administered according to the local standard of care. Duration of treatment was to be 6 - 12 cycles in the adjuvant phase and at the discretion of the investigator as supported by local standard of care.
RADIATIONRadiation
Radiation therapy treatment planning and administration was to be performed as per local institutional guidelines.
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM or WHO grade IV gliosarcoma * Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification * Tumors must be supratentorial in location * Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage * Participant has a Karnofsky performance status (KPS) of 70 or higher * Participant has adequate bone marrow, renal, and hepatic function * Electrocardiogram without evidence of acute cardiac ischemia ≤ 21 days prior to randomization * Participant has a life expectancy of ≥ 3 months
Exclusion criteria
* Participant has received prior chemotherapy or radiotherapy for cancer of the head and neck region * Participant has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment * Participant has hypersensitivity to any component of temozolomide or dacarbazine * Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) within 5 years of Study Day 1 * Participant has clinically significant uncontrolled condition(s) as described in the protocol * Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities * Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin * Participant has a history of herpetic keratitis * Participant is not suitable for receiving ocular steroids with conditions as described in the protocol * Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months * Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs) * Participant has hepatitis B virus or hepatitis C virus infection * Participant not receiving treatment with highly active antiretroviral therapy (HAART) when positive for human immunodeficiency virus (HIV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Required a Change in Ocular Side Effect (OSE) Management | Within 8 weeks after the initial dose of depatuxizumab mafodotin | Inadequate control of ocular side effects (OSE) was defined as either a ≥ 3-line decline from baseline (≥ +0.3 on LogMAR scale) in visual acuity (with baseline correction determined at the screening ophthalmology visit)) or ≥ Grade 3 OSE severity on the Corneal Epithelial Adverse Event (CEAE) scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Bandage Contact Lens (BCL) Intervention | Up to 9 months after the first dose of depatuxizumab mafodotin | The time to initiation of bandage contact lenses for those participants who required intervention due to inadequate control of ocular side effects (OSE) was calculated. |
| Number of Participants With Depatuxizumab Mafodotin Dose Modifications Due to Ocular Side Effects (OSE) | From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks | Dose modifications included depatuxizumab mafodotin withdrawal, interruption, and reductions in dose initiated due to OSEs. |
| Cumulative Dose of Depatuxizumab Mafodotin Received During Chemoradiation and During Adjuvant Treatment | Up to 9 months | The cumulative dose of depatuxizumab mafodotin administered was tabulated. |
| Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Up to 47 weeks | The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3). |
| Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention | From the last assessment prior to BCL intervention to 2 weeks after BCL intervention | The change on the LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention was calculated. The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment. |
| Maximum Change From Baseline on the Logarithm of the Minimum Angle of Resolution (LogMAR) Scale | Within 8 weeks after the initial dose of depatuxizumab mafodotin | The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment. The baseline observation is defined as the last non-missing measurement collected prior to the first dose of depatuxizumab mafodotin. |
| Number of Participants With Depatuxizumab Mafodotin Dose Modifications to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention | From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks | Dose modifications included depatuxizumab mafodotin withdrawal, interruption, and reductions in dose initiated due to OSEs after BCL intervention. |
| Time to Restart Depatuxizumab Mafodotin if Interrupted Due to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention | From the last assessment prior to BCL intervention to the end of BCL intervention | The time to restart depatuxizumab mafodotin treatment if it was interrupted due to ocular side effects after BCL Intervention was tabulated. |
| Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks | The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3). |
| Time to Ocular Side Effect (OSE) Symptom Resolution After Drug Discontinuation (Reversibility) | From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks | The time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility) was to be recorded. |
| Time to Re-initiation of Depatuxizumab Mafodotin After Dose Interruption | Up to 9 months | The time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin was to be recorded. |
| Percentage of Participants That Recovered to <3-line Decline From Baseline (≤ +0.3 LogMAR) in Visual Acuity After Bandage Contact Lens (BCL) Intervention | From the last assessment prior to BCL intervention to the end of BCL intervention | Recovery was defined as return to \<3-line decline from baseline (≤ +0.3 LogMAR) in visual acuity after BCL intervention. |
Countries
Australia, Germany, Netherlands, United Kingdom, United States
Participant flow
Pre-assignment details
All randomized participants
Participants by arm
| Arm | Count |
|---|---|
| Standard Steroids Steroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days | 14 |
| Standard Steroids + Vasoconstrictor + Cold Compress Steroid eye drops: 1 drop each eye, 3 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. The cold compress was to be applied in increments no longer than 30 min (could be shorter if the participant was uncomfortable). | 12 |
| Enhanced Steroids + Vasoconstrictor + Cold Compress Enhanced steroid eye drops: 1 drop each eye, 6 times/day, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Ophthalmic Steroid Ointment; applied to each eye once daily before sleep, starting 2 days prior to depatuxizumab mafodotin infusion and continuing until 4 days after infusion, for a total of 7 days; Vasoconstrictor Eye Drops: 1 drop each eye 4 - 6 times on day of infusion in total (5 - 10 minutes before infusion; at end of infusion; and 2 - 4 times during the remainder of the infusion day). Continuing 4 - 6 times/day on Day 1 and Day 2 after each depatuxizumab mafodotin infusion; Cold Compress: Starting 5 minutes prior to start of infusion and continuing for 30 minutes past end of infusion, and then use at least 2 hours total/day on Days 1 - 3 with each depatuxizumab mafodotin infusion. Cold compress was to be applied in increments no longer than 30 min (could be shorter if the patient is uncomfortable). | 12 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Left study due to COVID-19 restrictions | 1 | 1 | 0 | 0 |
| Overall Study | Other, not specified | 6 | 4 | 5 | 1 |
| Overall Study | Progressive disease (per protocol) | 0 | 2 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 2 | 5 | 1 |
Baseline characteristics
| Characteristic | Total | Standard Steroids | Standard Steroids + Vasoconstrictor + Cold Compress | Enhanced Steroids + Vasoconstrictor + Cold Compress |
|---|---|---|---|---|
| Age, Continuous | 53.1 years STANDARD_DEVIATION 10.39 | 47.6 years STANDARD_DEVIATION 9.85 | 55.2 years STANDARD_DEVIATION 10.53 | 57.3 years STANDARD_DEVIATION 8.69 |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 36 Participants | 12 Participants | 12 Participants | 12 Participants |
| Sex: Female, Male Female | 8 Participants | 3 Participants | 4 Participants | 1 Participants |
| Sex: Female, Male Male | 30 Participants | 11 Participants | 8 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 14 | 1 / 12 | 1 / 12 |
| other Total, other adverse events | 14 / 14 | 12 / 12 | 12 / 12 |
| serious Total, serious adverse events | 6 / 14 | 4 / 12 | 4 / 12 |
Outcome results
Primary
Percentage of Participants Who Required a Change in Ocular Side Effect (OSE) Management
Inadequate control of ocular side effects (OSE) was defined as either a ≥ 3-line decline from baseline (≥ +0.3 on LogMAR scale) in visual acuity (with baseline correction determined at the screening ophthalmology visit)) or ≥ Grade 3 OSE severity on the Corneal Epithelial Adverse Event (CEAE) scale.
Time frame: Within 8 weeks after the initial dose of depatuxizumab mafodotin
Population: Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had at least 1 post-baseline assessment within 8 weeks after the initial dose for either LogMAR or CEAE
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Steroids | Percentage of Participants Who Required a Change in Ocular Side Effect (OSE) Management | Bilateral vision | 50.0 percentage of participants |
| Standard Steroids | Percentage of Participants Who Required a Change in Ocular Side Effect (OSE) Management | Vision in worst eye | 64.3 percentage of participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Percentage of Participants Who Required a Change in Ocular Side Effect (OSE) Management | Bilateral vision | 27.3 percentage of participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Percentage of Participants Who Required a Change in Ocular Side Effect (OSE) Management | Vision in worst eye | 72.7 percentage of participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Percentage of Participants Who Required a Change in Ocular Side Effect (OSE) Management | Bilateral vision | 41.7 percentage of participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Percentage of Participants Who Required a Change in Ocular Side Effect (OSE) Management | Vision in worst eye | 50.0 percentage of participants |
Secondary
Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention
The change on the LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention was calculated. The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.
Time frame: From the last assessment prior to BCL intervention to 2 weeks after BCL intervention
Population: Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Steroids | Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention | Within 8 weeks of first dose: Bilateral vision | 0.325 units on a scale | Standard Deviation 0.1248 |
| Standard Steroids | Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention | Within 8 weeks of first adjuvant dose: Vision in worst eye | -0.1 units on a scale | — |
| Standard Steroids | Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention | Within 8 weeks of first adjuvant dose: Bilateral vision | -0.1 units on a scale | — |
| Standard Steroids | Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention | Within 8 weeks of first dose: Vision in worst eye | 0.435 units on a scale | Standard Deviation 0.0574 |
| Standard Steroids + Vasoconstrictor + Cold Compress | Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention | Within 8 weeks of first adjuvant dose: Vision in worst eye | 0.33 units on a scale | Standard Deviation 0.0141 |
| Standard Steroids + Vasoconstrictor + Cold Compress | Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention | Within 8 weeks of first dose: Bilateral vision | 0.13 units on a scale | Standard Deviation 0.099 |
| Standard Steroids + Vasoconstrictor + Cold Compress | Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention | Within 8 weeks of first dose: Vision in worst eye | 0.52 units on a scale | Standard Deviation 0.3111 |
| Standard Steroids + Vasoconstrictor + Cold Compress | Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention | Within 8 weeks of first adjuvant dose: Bilateral vision | 0.41 units on a scale | Standard Deviation 0.2404 |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention | Within 8 weeks of first dose: Vision in worst eye | 0.867 units on a scale | Standard Deviation 0.2914 |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Change From Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale After Bandage Contact Lens (BCL) Intervention | Within 8 weeks of first dose: Bilateral vision | 0.54 units on a scale | Standard Deviation 0.1442 |
Secondary
Cumulative Dose of Depatuxizumab Mafodotin Received During Chemoradiation and During Adjuvant Treatment
The cumulative dose of depatuxizumab mafodotin administered was tabulated.
Time frame: Up to 9 months
Population: Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Steroids | Cumulative Dose of Depatuxizumab Mafodotin Received During Chemoradiation and During Adjuvant Treatment | 8.5 mg/kg | Standard Deviation 5.86 |
| Standard Steroids + Vasoconstrictor + Cold Compress | Cumulative Dose of Depatuxizumab Mafodotin Received During Chemoradiation and During Adjuvant Treatment | 10.5 mg/kg | Standard Deviation 7.35 |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Cumulative Dose of Depatuxizumab Mafodotin Received During Chemoradiation and During Adjuvant Treatment | 7.0 mg/kg | Standard Deviation 3.67 |
Secondary
Maximum Change From Baseline on the Logarithm of the Minimum Angle of Resolution (LogMAR) Scale
The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment. The baseline observation is defined as the last non-missing measurement collected prior to the first dose of depatuxizumab mafodotin.
Time frame: Within 8 weeks after the initial dose of depatuxizumab mafodotin
Population: Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Steroids | Maximum Change From Baseline on the Logarithm of the Minimum Angle of Resolution (LogMAR) Scale | Bilateral vision | 0.353 units on a scale | Standard Deviation 0.1888 |
| Standard Steroids | Maximum Change From Baseline on the Logarithm of the Minimum Angle of Resolution (LogMAR) Scale | Vision in worst eye | 0.482 units on a scale | Standard Deviation 0.2028 |
| Standard Steroids + Vasoconstrictor + Cold Compress | Maximum Change From Baseline on the Logarithm of the Minimum Angle of Resolution (LogMAR) Scale | Bilateral vision | 0.402 units on a scale | Standard Deviation 0.1985 |
| Standard Steroids + Vasoconstrictor + Cold Compress | Maximum Change From Baseline on the Logarithm of the Minimum Angle of Resolution (LogMAR) Scale | Vision in worst eye | 0.528 units on a scale | Standard Deviation 0.3073 |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Maximum Change From Baseline on the Logarithm of the Minimum Angle of Resolution (LogMAR) Scale | Bilateral vision | 0.272 units on a scale | Standard Deviation 0.3888 |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Maximum Change From Baseline on the Logarithm of the Minimum Angle of Resolution (LogMAR) Scale | Vision in worst eye | 0.430 units on a scale | Standard Deviation 0.512 |
Secondary
Number of Participants With Depatuxizumab Mafodotin Dose Modifications Due to Ocular Side Effects (OSE)
Dose modifications included depatuxizumab mafodotin withdrawal, interruption, and reductions in dose initiated due to OSEs.
Time frame: From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks
Population: Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Steroids | Number of Participants With Depatuxizumab Mafodotin Dose Modifications Due to Ocular Side Effects (OSE) | 2 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Number of Participants With Depatuxizumab Mafodotin Dose Modifications Due to Ocular Side Effects (OSE) | 3 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Number of Participants With Depatuxizumab Mafodotin Dose Modifications Due to Ocular Side Effects (OSE) | 2 Participants |
Secondary
Number of Participants With Depatuxizumab Mafodotin Dose Modifications to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention
Dose modifications included depatuxizumab mafodotin withdrawal, interruption, and reductions in dose initiated due to OSEs after BCL intervention.
Time frame: From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks
Population: Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Steroids | Number of Participants With Depatuxizumab Mafodotin Dose Modifications to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention | 2 participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Number of Participants With Depatuxizumab Mafodotin Dose Modifications to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention | 1 participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Number of Participants With Depatuxizumab Mafodotin Dose Modifications to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention | 0 participants |
Secondary
Percentage of Participants That Recovered to <3-line Decline From Baseline (≤ +0.3 LogMAR) in Visual Acuity After Bandage Contact Lens (BCL) Intervention
Recovery was defined as return to \<3-line decline from baseline (≤ +0.3 LogMAR) in visual acuity after BCL intervention.
Time frame: From the last assessment prior to BCL intervention to the end of BCL intervention
Population: Data were not collected for this outcome (due to early termination of the study).
Secondary
Time to Bandage Contact Lens (BCL) Intervention
The time to initiation of bandage contact lenses for those participants who required intervention due to inadequate control of ocular side effects (OSE) was calculated.
Time frame: Up to 9 months after the first dose of depatuxizumab mafodotin
Population: Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Steroids | Time to Bandage Contact Lens (BCL) Intervention | NA months |
| Standard Steroids + Vasoconstrictor + Cold Compress | Time to Bandage Contact Lens (BCL) Intervention | 3.6 months |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Time to Bandage Contact Lens (BCL) Intervention | 2.1 months |
Secondary
Time to Ocular Side Effect (OSE) Symptom Resolution After Drug Discontinuation (Reversibility)
The time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility) was to be recorded.
Time frame: From the first dose of study drug until 49 days after last depatuxizumab mafodotin administration, up to 47 weeks
Population: Data were not collected for this outcome (due to early termination of the study).
Secondary
Time to Re-initiation of Depatuxizumab Mafodotin After Dose Interruption
The time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin was to be recorded.
Time frame: Up to 9 months
Population: Data were not collected for this outcome (due to early termination of the study).
Secondary
Time to Restart Depatuxizumab Mafodotin if Interrupted Due to Ocular Side Effects After Bandage Contact Lens (BCL) Intervention
The time to restart depatuxizumab mafodotin treatment if it was interrupted due to ocular side effects after BCL Intervention was tabulated.
Time frame: From the last assessment prior to BCL intervention to the end of BCL intervention
Population: Data were not collected for this outcome (due to early termination of the study).
Secondary
Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit
The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3).
Time frame: Up to 47 weeks
Population: Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 17: Grade 1 | 0 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 9: Grade 2 | 2 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 5: Grade 1 | 7 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 9: Grade 3 | 1 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 13: Grade 0 | 0 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 7: Grade 2 | 4 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 13: Grade 1 | 0 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 5: Grade 2 | 1 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 13: Grade 2 | 2 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 13: Grade 3 | 1 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 9: Grade 1 | 1 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 17: Grade 0 | 0 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 5: Grade 3 | 4 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 9: Grade 1 | 0 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 17: Grade 2 | 2 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 21: Grade 1 | 0 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 7: Grade 0 | 0 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 21: Grade 2 | 2 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 25: Grade 1 | 0 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 25: Grade 2 | 1 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 29: Grade 2 | 1 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 9: Grade 2 | 3 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 29: Grade 4 | 0 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 1: Grade 0 | 10 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 9: Grade 3 | 2 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 11: Grade 0 | 0 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 11: Grade 1 | 2 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 1: Grade 1 | 1 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 11: Grade 2 | 2 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 11: Grade 3 | 1 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 7: Grade 3 | 2 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 11: Grade 4 | 1 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 3: Grade 0 | 4 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 13: Grade 1 | 1 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 1: Grade 0 | 0 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 1: Grade 1 | 1 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 3: Grade 1 | 10 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 1: Grade 2 | 3 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 1: Grade 3 | 1 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 7: Grade 1 | 3 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 5: Grade 0 | 0 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 3: Grade 2 | 0 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 5: Grade 1 | 1 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 5: Grade 2 | 4 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 9: Grade 0 | 1 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 5: Grade 3 | 1 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 5: Grade 0 | 1 Participants |
| Standard Steroids | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 9: Grade 0 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 9: Grade 0 | 1 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 9: Grade 1 | 2 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 9: Grade 0 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 9: Grade 3 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 9: Grade 2 | 2 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 1: Grade 0 | 8 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 1: Grade 1 | 3 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 9: Grade 3 | 1 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 5: Grade 1 | 5 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 11: Grade 0 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 13: Grade 0 | 1 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 7: Grade 1 | 4 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 5: Grade 0 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 13: Grade 1 | 2 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 11: Grade 1 | 1 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 5: Grade 1 | 3 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 13: Grade 2 | 2 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 5: Grade 2 | 3 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 1: Grade 2 | 2 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 13: Grade 3 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 11: Grade 2 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 1: Grade 1 | 3 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 17: Grade 0 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 3: Grade 1 | 6 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 11: Grade 3 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 17: Grade 1 | 1 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 5: Grade 3 | 2 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 3: Grade 2 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 17: Grade 2 | 3 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 9: Grade 1 | 2 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 1: Grade 3 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 21: Grade 1 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 11: Grade 4 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 5: Grade 3 | 1 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 21: Grade 2 | 3 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 7: Grade 0 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 5: Grade 2 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 25: Grade 1 | 2 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 7: Grade 2 | 6 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 13: Grade 1 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 25: Grade 2 | 1 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 9: Grade 2 | 5 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 3: Grade 0 | 5 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 29: Grade 2 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 5: Grade 0 | 2 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 1: Grade 0 | 1 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 29: Grade 4 | 1 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 7: Grade 3 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 29: Grade 4 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 7: Grade 1 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 7: Grade 2 | 5 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 7: Grade 3 | 2 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 9: Grade 0 | 1 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 9: Grade 1 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 1: Grade 0 | 5 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 1: Grade 1 | 1 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 3: Grade 0 | 7 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 3: Grade 1 | 3 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 3: Grade 2 | 1 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 5: Grade 0 | 2 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 5: Grade 1 | 6 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 5: Grade 2 | 2 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 5: Grade 3 | 2 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 7: Grade 0 | 2 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 9: Grade 2 | 4 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 9: Grade 3 | 1 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 11: Grade 0 | 1 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 11: Grade 1 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 11: Grade 2 | 3 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 11: Grade 3 | 1 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 11: Grade 4 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Week 13: Grade 1 | 1 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 1: Grade 0 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 1: Grade 1 | 2 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 1: Grade 2 | 2 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 1: Grade 3 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 5: Grade 0 | 2 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 5: Grade 1 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 5: Grade 2 | 1 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 5: Grade 3 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 9: Grade 0 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 9: Grade 1 | 1 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 9: Grade 2 | 2 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 9: Grade 3 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 13: Grade 0 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 13: Grade 1 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 13: Grade 2 | 2 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 13: Grade 3 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 17: Grade 0 | 1 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 17: Grade 1 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 17: Grade 2 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 21: Grade 1 | 1 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 21: Grade 2 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 25: Grade 1 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 25: Grade 2 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment-Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit | Adj Week 29: Grade 2 | 0 Participants |
Secondary
Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention
The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3).
Time frame: From the last assessment prior to BCL intervention to the end of BCL intervention, up to 38 weeks
Population: Safety population: all randomized participants who received at least 1 dose of depatuxizumab mafodotin and had available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 1: Grade 1 | 0 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Week 7: Grade 2 | 1 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Week 9: Grade 2 | 1 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Week 11: Grade 2 | 0 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Week 11: Grade 3 | 1 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Week 13: Grade 1 | 1 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Week 5: Grade 1 | 2 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 1: Grade 2 | 0 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 5: Grade 0 | 0 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 5: Grade 1 | 0 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 5: Grade 2 | 1 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 5: Grade 3 | 1 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 9: Grade 0 | 0 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 9: Grade 1 | 0 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 9: Grade 2 | 0 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 9: Grade 3 | 1 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 13: Grade 0 | 0 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 13: Grade 1 | 0 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 13: Grade 2 | 1 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 13: Grade 3 | 1 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 17: Grade 1 | 0 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 17: Grade 2 | 1 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 21: Grade 2 | 2 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 25: Grade 1 | 0 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 25: Grade 2 | 1 Participants |
| Standard Steroids | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 29: Grade 2 | 1 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 5: Grade 0 | 1 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 17: Grade 1 | 1 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 5: Grade 1 | 1 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 5: Grade 2 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 25: Grade 2 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 5: Grade 3 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 17: Grade 2 | 1 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 9: Grade 0 | 1 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 9: Grade 1 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 9: Grade 2 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 21: Grade 2 | 1 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 9: Grade 3 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 13: Grade 0 | 2 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 13: Grade 1 | 1 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Week 5: Grade 1 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Week 7: Grade 2 | 1 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 25: Grade 1 | 1 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Week 9: Grade 2 | 1 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 13: Grade 2 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Week 11: Grade 2 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Week 11: Grade 3 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Week 13: Grade 1 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 13: Grade 3 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 1: Grade 1 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 1: Grade 2 | 0 Participants |
| Standard Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 29: Grade 2 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 1: Grade 1 | 1 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Week 11: Grade 3 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Week 5: Grade 1 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 5: Grade 1 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 17: Grade 1 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 13: Grade 1 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 5: Grade 2 | 1 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 25: Grade 1 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Week 7: Grade 2 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 5: Grade 3 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 13: Grade 3 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Week 13: Grade 1 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 9: Grade 0 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 17: Grade 2 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Week 9: Grade 2 | 1 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 9: Grade 1 | 1 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 25: Grade 2 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 5: Grade 0 | 1 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 9: Grade 2 | 1 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 1: Grade 2 | 1 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Week 11: Grade 2 | 2 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 9: Grade 3 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 21: Grade 2 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 13: Grade 2 | 1 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 13: Grade 0 | 0 Participants |
| Enhanced Steroids + Vasoconstrictor + Cold Compress | Treatment Emergent Corneal Epithelial Adverse Event (CEAE) Grade at Each Visit After Bandage Contact Lens (BCL) Intervention | Adj Week 29: Grade 2 | 0 Participants |