Evaluation of Efficacy and Safety of SDN-037



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:11/16/2018
Start Date:September 28, 2018
End Date:June 30, 2019
Contact:Sun Pharma Advanced Research Company Limited
Email:clinical.trials@sparcmail.com
Phone:912266455645

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A Randomized, Double-Masked, Parallel Group, Multicenter, Study To Evaluate Efficacy And Safety of SDN -037 Twice Daily Compared With Vehicle For The Treatment Of Inflammation And Pain Associated With Ocular Surgery.

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.


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
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Paducah, Kentucky 42001
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Chandler, Arizona 85225
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