Evaluation of Efficacy and Safety of SDN-037

Completed · Phase 3 · Has a placebo group

Conditions studied: Inflammation and Pain Associated With Ocular Surgery

In brief

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.

Key facts

Study ID

NCT03426267

Run by

Sun Pharma Advanced Research Company Limited

People needed

325

Starts

2018-09-28

Expected to finish

2020-03-05

Last updated by the study team

2021-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• SPARC Site 13 — Chandler, Arizona, United States
• SPARC Site 14 — Mesa, Arizona, United States
• SPARC Site 11 — Prescott, Arizona, United States
• SPARC Site 12 — Sun City, Arizona, United States
• SPARC site 01 — Fayetteville, Arkansas, United States
• SPARC Site 10 — Santa Barbara, California, United States
• SPARC Site 08 — Colorado Springs, Colorado, United States
• SPARC Site 06 — Coral Springs, Florida, United States
• SPARC Site 18 — Fort Myers, Florida, United States
• SPARC Site 16 — Jacksonville, Florida, United States
• SPARC Site 07 — Miami, Florida, United States
• SPARC Site 15 — Paducah, Kentucky, United States
• SPARC Site 05 — Saint Joseph, Michigan, United States
• SPARC Site 09 — Henderson, Nevada, United States
• SPARC Site 03 — Poughkeepsie, New York, United States
• SPARC Site 04 — Winston-Salem, North Carolina, United States
• SPARC Site 17 — Fargo, North Dakota, United States
• SPARC Site 19 — Austin, Texas, United States
• SPARC Site 2 — Mission, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.