Vernal Keratoconjunctivitis
Conditions
Keywords
vernal keratoconjunctivitis, ciclosporin, cyclosporine
Brief summary
The objective of this study is to compare the efficacy of two different dosing regimen of NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of the formulation) administered four times a day in patients with severe vernal keratoconjunctivitis after 4 months of treatment.
Interventions
DRUGNOVA22007 ''Ciclosporin''
Sterile, ophthalmic cationic oil-in-water emulsion containing 1 mg/ml Ciclosporin.
DRUGPlacebo
Sterile, drug-free, cationic ophthalmic oil-in-water emulsion containing 0 mg/ml Ciclosporin.
Sponsors
Santen SAS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Males or females from 4 to less than 18 years of age. * History of at least one recurrence of vernal keratoconjunctivitis (VKC) in the past year prior to enrolment. * Patients not receiving any treatment for an established and active VKC; or patients already receiving treatment for their VKC provided treatment is stopped according to the wash-out period specified in the
Exclusion criteria
. * Active severe VKC consistent with grade 3 or 4 of Bonini scale (Bonini 2007) with severe keratitis (grade 4 or 5 on the modified Oxford scale). * Mean score of 4 subjective symptoms (photophobia, tearing, itching and mucous discharge) ≥ 60 mm using a 100 mm Visual Analogue Scale (where 0 means no symptom and 100 means the worst that have been ever experienced).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Penalties Adjusted Composite Efficacy Score (CFS) Score Over the 4 Months | over the 4 months | Efficacy was assessed every month during the 4-month treatment phase and compared with Baseline using a composite criterion based on: * Keratitis assessed by the modified Oxford scale (7-point ordinal scale, score 0, 0.5, and 1 to 5). On this modified scale, the score 0 corresponded to no staining dots and the score 0.5 to three or less staining dots. A CFS grade of 0 represented complete corneal clearing. * Need for rescue medication. * Occurrence of corneal ulceration. An efficacy score was calculated as follows: Patient's score at month X = CFS (Baseline) - CFS (Month X) + penalty (ies) Penalty for rescue medication: -1 (per course, with a maximum of 2 courses between 2 scheduled visits) Penalty for corneal ulceration: -1 (per occurrence). A positive value indicated improvement. The maximum CFS is five and the minimum cannot be set due to the number of rescue medication and ulceration which decreases the penalty adjusted CFS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Up to Month4 | Best corrected distance visual acuity (BCDVA) was measured with the patient's best correction and recorded in LogMAR (log of the Minimum Angle of Resolution) A negative LogMar BCDVA measure shows an improvement, whereas positive values indicates poor vision. |
| Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Up to Month12 | Best corrected distance visual acuity (BCDVA) was measured with the patient's best correction and recorded in LogMAR (log of the Minimum Angle of Resolution) A negative LogMar BCDVA measure shows an improvement, whereas positive values indicate poor vision. |
| Number of Courses of Rescue Medication in Period I | Up to Month4 | Use of rescue medication: the total number of topical corticosteroid courses was assessed at each visit during the 4-month efficacy evaluation treatment period. |
Countries
Croatia, France, Germany, Greece, Hungary, India, Israel, Italy, Portugal, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High Dose Regimen 1 drop of CsA (NOVA22007) 1 mg/mL 4 times a day as monotherapy (morning, noon, afternoon and evening). | 56 |
| Low Dose Regimen 1 drop of CsA (NOVA22007) 1 mg/mL twice a day and 1 drop of placebo twice a day (active study treatment morning and evening and placebo noon and afternoon) as monotherapy. | 54 |
| Placebo 1 drop of placebo 4 times a day as monotherapy. | 58 |
| Total | 168 |
Baseline characteristics
| Characteristic | High Dose Regimen | Low Dose Regimen | Placebo | Total |
|---|---|---|---|---|
| Age, Customized Children (4-18 years) | 9.1 years STANDARD_DEVIATION 3.3 | 9.6 years STANDARD_DEVIATION 3.4 | 8.9 years STANDARD_DEVIATION 3.2 | 9.2 years STANDARD_DEVIATION 3.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 11 Participants | 13 Participants | 35 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 2 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 40 Participants | 38 Participants | 41 Participants | 119 Participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 12 Participants | 36 Participants |
| Sex: Female, Male Male | 44 Participants | 42 Participants | 46 Participants | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 29 / 50 | 13 / 22 | 42 / 72 | 24 / 44 | 11 / 26 | 35 / 70 |
| serious Total, serious adverse events | 3 / 50 | 0 / 22 | 3 / 72 | 1 / 44 | 0 / 26 | 1 / 70 |
Outcome results
Primary
Average Penalties Adjusted Composite Efficacy Score (CFS) Score Over the 4 Months
Efficacy was assessed every month during the 4-month treatment phase and compared with Baseline using a composite criterion based on: * Keratitis assessed by the modified Oxford scale (7-point ordinal scale, score 0, 0.5, and 1 to 5). On this modified scale, the score 0 corresponded to no staining dots and the score 0.5 to three or less staining dots. A CFS grade of 0 represented complete corneal clearing. * Need for rescue medication. * Occurrence of corneal ulceration. An efficacy score was calculated as follows: Patient's score at month X = CFS (Baseline) - CFS (Month X) + penalty (ies) Penalty for rescue medication: -1 (per course, with a maximum of 2 courses between 2 scheduled visits) Penalty for corneal ulceration: -1 (per occurrence). A positive value indicated improvement. The maximum CFS is five and the minimum cannot be set due to the number of rescue medication and ulceration which decreases the penalty adjusted CFS.
Time frame: over the 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose Regimen | Average Penalties Adjusted Composite Efficacy Score (CFS) Score Over the 4 Months | 2.06 Penalties Adjusted CFS Score | Standard Deviation 1.44 |
| Low Dose Regimen | Average Penalties Adjusted Composite Efficacy Score (CFS) Score Over the 4 Months | 1.93 Penalties Adjusted CFS Score | Standard Deviation 1.37 |
| Placebo | Average Penalties Adjusted Composite Efficacy Score (CFS) Score Over the 4 Months | 1.34 Penalties Adjusted CFS Score | Standard Deviation 1.22 |
p-value: 0.00795% CI: [0.26, 1.27]t-test, 2 sided
p-value: 0.0195% CI: [0.16, 1.18]ANCOVA
Secondary
Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I
Best corrected distance visual acuity (BCDVA) was measured with the patient's best correction and recorded in LogMAR (log of the Minimum Angle of Resolution) A negative LogMar BCDVA measure shows an improvement, whereas positive values indicates poor vision.
Time frame: Up to Month4
Population: SS population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 4/ Early Termination | 0.158 letters | Standard Deviation 0.249 |
| High Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 2 | 0.221 letters | Standard Deviation 0.251 |
| High Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 4 | 0.149 letters | Standard Deviation 0.244 |
| High Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 3 | 0.172 letters | Standard Deviation 0.235 |
| High Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Baseline | 0.293 letters | Standard Deviation 0.297 |
| High Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 1 | 0.263 letters | Standard Deviation 0.292 |
| Low Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 3 | 0.110 letters | Standard Deviation 0.204 |
| Low Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Baseline | 0.209 letters | Standard Deviation 0.284 |
| Low Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 2 | 0.146 letters | Standard Deviation 0.214 |
| Low Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 4 | 0.097 letters | Standard Deviation 0.203 |
| Low Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 1 | 0.160 letters | Standard Deviation 0.241 |
| Low Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 4/ Early Termination | 0.114 letters | Standard Deviation 0.212 |
| Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 2 | 0.331 letters | Standard Deviation 0.352 |
| Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 4/ Early Termination | 0.217 letters | Standard Deviation 0.295 |
| Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 1 | 0.285 letters | Standard Deviation 0.362 |
| Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Baseline | 0.302 letters | Standard Deviation 0.347 |
| Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 3 | 0.273 letters | Standard Deviation 0.318 |
| Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 4 | 0.237 letters | Standard Deviation 0.308 |
| Change From Baseline in LogMAR- High Dose | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 3 | -0.110 letters | Standard Deviation 0.173 |
| Change From Baseline in LogMAR- High Dose | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 4/ Early Termination | -0.135 letters | Standard Deviation 0.22 |
| Change From Baseline in LogMAR- High Dose | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 1 | -0.036 letters | Standard Deviation 0.187 |
| Change From Baseline in LogMAR- High Dose | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Baseline | 0 letters | Standard Deviation 0 |
| Change From Baseline in LogMAR- High Dose | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 2 | -0.071 letters | Standard Deviation 0.191 |
| Change From Baseline in LogMAR- High Dose | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 4 | -0.127 letters | Standard Deviation 0.165 |
| Change From Baseline in LogMAR- Low Dose | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 2 | -0.073 letters | Standard Deviation 0.202 |
| Change From Baseline in LogMAR- Low Dose | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 4 | -0.110 letters | Standard Deviation 0.233 |
| Change From Baseline in LogMAR- Low Dose | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 3 | -0.089 letters | Standard Deviation 0.233 |
| Change From Baseline in LogMAR- Low Dose | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 4/ Early Termination | -0.091 letters | Standard Deviation 0.257 |
| Change From Baseline in LogMAR- Low Dose | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Baseline | 0 letters | Standard Deviation 0 |
| Change From Baseline in LogMAR- Low Dose | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 1 | -0.058 letters | Standard Deviation 0.199 |
| Change From Baseline in LogMAR- Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 4/ Early Termination | -0.097 letters | Standard Deviation 0.21 |
| Change From Baseline in LogMAR- Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Baseline | 0 letters | Standard Deviation 0 |
| Change From Baseline in LogMAR- Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 1 | -0.027 letters | Standard Deviation 0.182 |
| Change From Baseline in LogMAR- Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 2 | 0.003 letters | Standard Deviation 0.233 |
| Change From Baseline in LogMAR- Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 3 | -0.066 letters | Standard Deviation 0.229 |
| Change From Baseline in LogMAR- Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I | Analysis Eye-Month 4 | -0.109 letters | Standard Deviation 0.211 |
Secondary
Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II
Best corrected distance visual acuity (BCDVA) was measured with the patient's best correction and recorded in LogMAR (log of the Minimum Angle of Resolution) A negative LogMar BCDVA measure shows an improvement, whereas positive values indicate poor vision.
Time frame: Up to Month12
Population: SS population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 12/ Early Termination | 0.136 letters | Standard Deviation 0.212 |
| High Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Baseline (Month 4) | 0.152 letters | Standard Deviation 0.246 |
| High Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 6 | 0.128 letters | Standard Deviation 0.23 |
| High Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 8 | 0.141 letters | Standard Deviation 0.228 |
| High Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 10 | 0.141 letters | Standard Deviation 0.222 |
| High Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 12 | 0.134 letters | Standard Deviation 0.214 |
| Low Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 12/ Early Termination | 0.220 letters | Standard Deviation 0.363 |
| Low Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 12 | 0.220 letters | Standard Deviation 0.363 |
| Low Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 10 | 0.207 letters | Standard Deviation 0.325 |
| Low Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 6 | 0.258 letters | Standard Deviation 0.359 |
| Low Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 8 | 0.222 letters | Standard Deviation 0.324 |
| Low Dose Regimen | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Baseline (Month 4) | 0.250 letters | Standard Deviation 0.317 |
| Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 6 | 0.168 letters | Standard Deviation 0.28 |
| Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Baseline (Month 4) | 0.181 letters | Standard Deviation 0.27 |
| Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 12 | 0.160 letters | Standard Deviation 0.268 |
| Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 10 | 0.160 letters | Standard Deviation 0.257 |
| Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 12/ Early Termination | 0.161 letters | Standard Deviation 0.266 |
| Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 8 | 0.165 letters | Standard Deviation 0.261 |
| Change From Baseline in LogMAR- High Dose | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 8 | -0.015 letters | Standard Deviation 0.136 |
| Change From Baseline in LogMAR- High Dose | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 6 | -0.024 letters | Standard Deviation 0.114 |
| Change From Baseline in LogMAR- High Dose | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 10 | -0.014 letters | Standard Deviation 0.149 |
| Change From Baseline in LogMAR- High Dose | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 12/ Early Termination | -0.016 letters | Standard Deviation 0.154 |
| Change From Baseline in LogMAR- High Dose | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 12 | -0.020 letters | Standard Deviation 0.152 |
| Change From Baseline in LogMAR- High Dose | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Baseline (Month 4) | 0 letters | Standard Deviation 0 |
| Change From Baseline in LogMAR- Low Dose | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 6 | -0.017 letters | Standard Deviation 0.143 |
| Change From Baseline in LogMAR- Low Dose | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Baseline (Month 4) | 0 letters | Standard Deviation 0 |
| Change From Baseline in LogMAR- Low Dose | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 8 | -0.029 letters | Standard Deviation 0.155 |
| Change From Baseline in LogMAR- Low Dose | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 10 | -0.044 letters | Standard Deviation 0.128 |
| Change From Baseline in LogMAR- Low Dose | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 12 | -0.030 letters | Standard Deviation 0.172 |
| Change From Baseline in LogMAR- Low Dose | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 12/ Early Termination | -0.030 letters | Standard Deviation 0.172 |
| Change From Baseline in LogMAR- Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 10 | -0.023 letters | Standard Deviation 0.143 |
| Change From Baseline in LogMAR- Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 8 | -0.019 letters | Standard Deviation 0.141 |
| Change From Baseline in LogMAR- Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 6 | -0.022 letters | Standard Deviation 0.122 |
| Change From Baseline in LogMAR- Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Baseline (Month 4) | 0 letters | Standard Deviation 0 |
| Change From Baseline in LogMAR- Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 12/ Early Termination | -0.020 letters | Standard Deviation 0.158 |
| Change From Baseline in LogMAR- Placebo | Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II | Analysis Eye-Month 12 | -0.023 letters | Standard Deviation 0.157 |
Secondary
Number of Courses of Rescue Medication in Period I
Use of rescue medication: the total number of topical corticosteroid courses was assessed at each visit during the 4-month efficacy evaluation treatment period.
Time frame: Up to Month4
Population: Participants reduced due to missing data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High Dose Regimen | Number of Courses of Rescue Medication in Period I | Month 4, two courses | 2 Participants |
| High Dose Regimen | Number of Courses of Rescue Medication in Period I | Month 2, two courses | 2 Participants |
| High Dose Regimen | Number of Courses of Rescue Medication in Period I | Month 4/Early Termination, one course | 7 Participants |
| High Dose Regimen | Number of Courses of Rescue Medication in Period I | Month4, one course | 6 Participants |
| High Dose Regimen | Number of Courses of Rescue Medication in Period I | Month3, zero course | 43 Participants |
| High Dose Regimen | Number of Courses of Rescue Medication in Period I | Month1, two courses | 0 Participants |
| High Dose Regimen | Number of Courses of Rescue Medication in Period I | Month4, zero course | 42 Participants |
| High Dose Regimen | Number of Courses of Rescue Medication in Period I | Month 4/Early Termination, two courses | 3 Participants |
| High Dose Regimen | Number of Courses of Rescue Medication in Period I | Month 3, two courses | 1 Participants |
| High Dose Regimen | Number of Courses of Rescue Medication in Period I | Month 4/Early Termination, zero course | 46 Participants |
| High Dose Regimen | Number of Courses of Rescue Medication in Period I | Month2, zero course | 45 Participants |
| High Dose Regimen | Number of Courses of Rescue Medication in Period I | Month 1, one course | 3 Participants |
| High Dose Regimen | Number of Courses of Rescue Medication in Period I | Month3, one course | 7 Participants |
| High Dose Regimen | Number of Courses of Rescue Medication in Period I | Month 2, one course | 6 Participants |
| High Dose Regimen | Number of Courses of Rescue Medication in Period I | Month1, zero course | 51 Participants |
| Low Dose Regimen | Number of Courses of Rescue Medication in Period I | Month 4, two courses | 1 Participants |
| Low Dose Regimen | Number of Courses of Rescue Medication in Period I | Month1, zero course | 41 Participants |
| Low Dose Regimen | Number of Courses of Rescue Medication in Period I | Month 1, one course | 7 Participants |
| Low Dose Regimen | Number of Courses of Rescue Medication in Period I | Month1, two courses | 2 Participants |
| Low Dose Regimen | Number of Courses of Rescue Medication in Period I | Month2, zero course | 43 Participants |
| Low Dose Regimen | Number of Courses of Rescue Medication in Period I | Month 2, one course | 2 Participants |
| Low Dose Regimen | Number of Courses of Rescue Medication in Period I | Month 2, two courses | 2 Participants |
| Low Dose Regimen | Number of Courses of Rescue Medication in Period I | Month3, zero course | 42 Participants |
| Low Dose Regimen | Number of Courses of Rescue Medication in Period I | Month3, one course | 2 Participants |
| Low Dose Regimen | Number of Courses of Rescue Medication in Period I | Month 3, two courses | 2 Participants |
| Low Dose Regimen | Number of Courses of Rescue Medication in Period I | Month4, zero course | 41 Participants |
| Low Dose Regimen | Number of Courses of Rescue Medication in Period I | Month4, one course | 2 Participants |
| Low Dose Regimen | Number of Courses of Rescue Medication in Period I | Month 4/Early Termination, zero course | 46 Participants |
| Low Dose Regimen | Number of Courses of Rescue Medication in Period I | Month 4/Early Termination, one course | 5 Participants |
| Low Dose Regimen | Number of Courses of Rescue Medication in Period I | Month 4/Early Termination, two courses | 3 Participants |
| Placebo | Number of Courses of Rescue Medication in Period I | Month 2, two courses | 3 Participants |
| Placebo | Number of Courses of Rescue Medication in Period I | Month 4/Early Termination, one course | 11 Participants |
| Placebo | Number of Courses of Rescue Medication in Period I | Month4, one course | 8 Participants |
| Placebo | Number of Courses of Rescue Medication in Period I | Month 2, one course | 11 Participants |
| Placebo | Number of Courses of Rescue Medication in Period I | Month2, zero course | 38 Participants |
| Placebo | Number of Courses of Rescue Medication in Period I | Month 4, two courses | 2 Participants |
| Placebo | Number of Courses of Rescue Medication in Period I | Month1, two courses | 2 Participants |
| Placebo | Number of Courses of Rescue Medication in Period I | Month1, zero course | 44 Participants |
| Placebo | Number of Courses of Rescue Medication in Period I | Month 4/Early Termination, zero course | 43 Participants |
| Placebo | Number of Courses of Rescue Medication in Period I | Month3, one course | 12 Participants |
| Placebo | Number of Courses of Rescue Medication in Period I | Month 1, one course | 11 Participants |
| Placebo | Number of Courses of Rescue Medication in Period I | Month 3, two courses | 4 Participants |
| Placebo | Number of Courses of Rescue Medication in Period I | Month3, zero course | 34 Participants |
| Placebo | Number of Courses of Rescue Medication in Period I | Month 4/Early Termination, two courses | 4 Participants |
| Placebo | Number of Courses of Rescue Medication in Period I | Month4, zero course | 38 Participants |