Status:
COMPLETED
Evaluation of Efficacy and Safety of SDN-037
Lead Sponsor:
Sun Pharma Advanced Research Company Limited
Conditions:
Inflammation and Pain Associated With Ocular Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2020
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT03426267
Start Date
September 28 2018
End Date
March 5 2020
Last Update
May 17 2021
Active Locations (19)
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1
SPARC Site 13
Chandler, Arizona, United States, 85224
2
SPARC Site 14
Mesa, Arizona, United States, 85208
3
SPARC Site 11
Prescott, Arizona, United States, 86301
4
SPARC Site 12
Sun City, Arizona, United States, 85351