Evaluation of Efficacy and Safety of SDN-037

Phase 3

Completed

• Conditions: Inflammation and Pain Associated With Ocular Surgery
• Interventions: Drug: Placebo; Drug: SDN-037

• Registration Number: NCT03426267
• Lead Sponsor: Sun Pharma Advanced Research Company Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-02
• Study First Posted: 2018-02-08
• Study Start: 2018-09-28
• Primary Completion: 2020-03-05
• Study Completion: 2020-03-05
• Results First Submitted: 2021-03-03
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-14
• Last Update Submitted: 2021-05-14
• Results First Posted: 2021-05-17
• Last Update Posted: 2021-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 325

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vehicle	Placebo	-
SDN-037	SDN-037	-

Primary Outcome Measures

Name	Time	Method
Subjects With an Anterior Chamber Cell Grade of 0 at Day 15	Day 15	Grade Cell Count 0 0; 1. 1-10; 2. 11-20; 3. 21-50; 4. \> 50; ACC grade of 0 at the Day 15 visit was considered a responder to therapy ACC score of \>0 at Day 15 visit was considered a failure (or non-responder)

Secondary Outcome Measures

Name	Time	Method
Subjects Who Achieve a Pain Score of 0 at Day 15	Day 15	Pain was assessed using a visual analog scale (VAS). The Visual Analog Scale (VAS) uses a 100 mm (10 cm) line (0 = absent \>100 = maximum). A 0 indicates an absence of pain A higher score indicates greater pain intensity.

Trial Locations

Locations (19)

SPARC Site 10; 🇺🇸 Santa Barbara, California, United States

SPARC Site 18; 🇺🇸 Fort Myers, Florida, United States

SPARC Site 12; 🇺🇸 Sun City, Arizona, United States

SPARC Site 13; 🇺🇸 Chandler, Arizona, United States

SPARC Site 07; 🇺🇸 Miami, Florida, United States

SPARC Site 17; 🇺🇸 Fargo, North Dakota, United States

SPARC Site 14; 🇺🇸 Mesa, Arizona, United States

SPARC Site 11; 🇺🇸 Prescott, Arizona, United States

SPARC site 01; 🇺🇸 Fayetteville, Arkansas, United States

SPARC Site 06; 🇺🇸 Coral Springs, Florida, United States

SPARC Site 08; 🇺🇸 Colorado Springs, Colorado, United States

SPARC Site 16; 🇺🇸 Jacksonville, Florida, United States

SPARC Site 15; 🇺🇸 Paducah, Kentucky, United States

SPARC Site 09; 🇺🇸 Henderson, Nevada, United States

SPARC Site 05; 🇺🇸 Saint Joseph, Michigan, United States

SPARC Site 04; 🇺🇸 Winston-Salem, North Carolina, United States

SPARC Site 03; 🇺🇸 Poughkeepsie, New York, United States

SPARC Site 19; 🇺🇸 Austin, Texas, United States

SPARC Site 2; 🇺🇸 Mission, Texas, United States