Inflammation and Pain Associated With Ocular Surgery
Conditions
Brief summary
The efficacy and safety of SDN-037 twice daily will be evaluated and compared with vehicle for the treatment of inflammation and pain associated with ocular surgery.
Interventions
DRUGSDN-037
twice daily
DRUGPlacebo
twice daily
Sponsors
Sun Pharma Advanced Research Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be at least 2 years of age on the date of assent or 18 years of age at the date of consent 2. Be able and willing to follow study instructions and complete all required visits 3. Females of childbearing potential must not be pregnant (as confirmed by a negative urine pregnancy test 4. Able to self-instill the IP or have a caregiver available to instil all doses of the IP
Exclusion criteria
1. Any known allergy or hypersensitivity to difluprednate therapy 2. An acute ocular infection (bacterial, viral or fungal) or active ocular inflammation in the study eye 3. Any active corneal pathology noted in the study eye 4. Currently suffering from alcohol and/or drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjects With an Anterior Chamber Cell Grade of 0 at Day 15 | Day 15 | Grade Cell Count 0 0 1. 1-10 2. 11-20 3. 21-50 4. \> 50 ACC grade of 0 at the Day 15 visit was considered a responder to therapy ACC score of \>0 at Day 15 visit was considered a failure (or non-responder) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjects Who Achieve a Pain Score of 0 at Day 15 | Day 15 | Pain was assessed using a visual analog scale (VAS). The Visual Analog Scale (VAS) uses a 100 mm (10 cm) line (0 = absent \>100 = maximum). A 0 indicates an absence of pain A higher score indicates greater pain intensity. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SDN-037 SDN-037: twice daily | 154 |
| Vehicle Placebo: twice daily | 144 |
| Total | 298 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 9 | 27 |
| Overall Study | Lack of Efficacy | 0 | 25 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | other | 3 | 0 |
| Overall Study | Physician Decision | 1 | 4 |
| Overall Study | Prohibited Treatment Intake | 2 | 3 |
| Overall Study | Protocol Violation | 1 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 10 |
Baseline characteristics
| Characteristic | Vehicle | Total | SDN-037 |
|---|---|---|---|
| Age, Continuous | 68.3 years STANDARD_DEVIATION 8.94 | 68.3 years STANDARD_DEVIATION 8.76 | 68.3 years STANDARD_DEVIATION 8.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 42 Participants | 81 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 102 Participants | 216 Participants | 114 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants | 65 Participants | 34 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 109 Participants | 224 Participants | 115 Participants |
| Sex: Female, Male Female | 84 Participants | 178 Participants | 94 Participants |
| Sex: Female, Male Male | 60 Participants | 120 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 154 | 0 / 144 |
| other Total, other adverse events | 87 / 154 | 96 / 144 |
| serious Total, serious adverse events | 2 / 154 | 2 / 144 |
Outcome results
Primary
Subjects With an Anterior Chamber Cell Grade of 0 at Day 15
Grade Cell Count 0 0 1. 1-10 2. 11-20 3. 21-50 4. \> 50 ACC grade of 0 at the Day 15 visit was considered a responder to therapy ACC score of \>0 at Day 15 visit was considered a failure (or non-responder)
Time frame: Day 15
Population: Modified Intent-to-Treat Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SDN-037 | Subjects With an Anterior Chamber Cell Grade of 0 at Day 15 | 96 Participants |
| Vehicle | Subjects With an Anterior Chamber Cell Grade of 0 at Day 15 | 30 Participants |
p-value: <0.0001Chi-squared
Secondary
Subjects Who Achieve a Pain Score of 0 at Day 15
Pain was assessed using a visual analog scale (VAS). The Visual Analog Scale (VAS) uses a 100 mm (10 cm) line (0 = absent \>100 = maximum). A 0 indicates an absence of pain A higher score indicates greater pain intensity.
Time frame: Day 15
Population: Modified Intent-To-Treat Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SDN-037 | Subjects Who Achieve a Pain Score of 0 at Day 15 | 151 Participants |
| Vehicle | Subjects Who Achieve a Pain Score of 0 at Day 15 | 106 Participants |
p-value: <0.0001Chi-squared