Phase 3
N=325
Evaluation of Efficacy and Safety of SDN-037
Inflammation and Pain Associated With Ocular Surgery
Bottom Line
View on ClinicalTrials.gov: NCT03426267 ↗Enrolled (actual)
325
Serious AEs
1.3%
Results posted
May 2021
Primary outcome: Primary: Subjects With an Anterior Chamber Cell Grade of 0 at Day 15 — 96; 30 Participants — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SDN-037 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sun Pharma Advanced Research Company Limited
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects With an Anterior Chamber Cell Grade of 0 at Day 15 |
96; 30 | <.0001 sig |
| SECONDARY Subjects Who Achieve a Pain Score of 0 at Day 15 |
151; 106 | <.0001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Be at least 2 years of age on the date of assent or 18 years of age at the date of consent
- Be able and willing to follow study instructions and complete all required visits
- Females of childbearing potential must not be pregnant (as confirmed by a negative urine pregnancy test
- Able to self-instill the IP or have a caregiver available to instil all doses of the IP
Exclusion Criteria
- Any known allergy or hypersensitivity to difluprednate therapy
- An acute ocular infection (bacterial, viral or fungal) or active ocular inflammation in the study eye
- Any active corneal pathology noted in the study eye
- Currently suffering from alcohol and/or drug abuse
Data sourced from ClinicalTrials.gov (NCT03426267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.