Evaluation of Efficacy and Safety of SDN-037

• Status: Completed
• Trial end date: 2020-03-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Criteria

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