Evaluation of Efficacy and Safety of SDN-037

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.

Study Overview

• Status: Completed
• Conditions: Inflammation and Pain Associated With Ocular Surgery
• Intervention / Treatment: Drug: Placebo; Drug: SDN-037

• Study Type: Interventional
• Enrollment (Actual): 325
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • SPARC Site 13
    • Mesa, Arizona, United States, 85208
      • SPARC Site 14
    • Prescott, Arizona, United States, 86301
      • SPARC Site 11
    • Sun City, Arizona, United States, 85351
      • SPARC Site 12
  • Arkansas
    • Fayetteville, Arkansas, United States, 72704
      • SPARC Site 01
  • California
    • Santa Barbara, California, United States, 93110
      • SPARC Site 10
  • Colorado
    • Colorado Springs, Colorado, United States, 80919
      • SPARC Site 08
  • Florida
    • Coral Springs, Florida, United States, 33067
      • SPARC Site 06
    • Fort Myers, Florida, United States, 33901
      • SPARC Site 18
    • Jacksonville, Florida, United States, 32204
      • SPARC Site 16
    • Miami, Florida, United States, 33143
      • SPARC Site 07
  • Kentucky
    • Paducah, Kentucky, United States, 42001
      • SPARC Site 15
  • Michigan
    • Saint Joseph, Michigan, United States, 49085
      • SPARC Site 05
  • Nevada
    • Henderson, Nevada, United States, 89052
      • SPARC Site 09
  • New York
    • Poughkeepsie, New York, United States, 12603
      • SPARC Site 03
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27101
      • SPARC Site 04
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • SPARC Site 17
  • Texas
    • Austin, Texas, United States, 78731
      • SPARC Site 19
    • Mission, Texas, United States, 78572
      • SPARC Site 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: vehicle	Drug: Placebo; twice daily
EXPERIMENTAL: SDN-037	Drug: SDN-037; twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects With an Anterior Chamber Cell Grade of 0 at Day 15	Grade Cell Count 0 0; 1-10; 11-20; 21-50; > 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)	Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects Who Achieve a Pain Score of 0 at 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.	Day 15

Collaborators and Investigators

• Sponsor: Sun Pharma Advanced Research Company Limited

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 28, 2018
• Primary Completion (ACTUAL): March 5, 2020
• Study Completion (ACTUAL): March 5, 2020

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (ACTUAL): February 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 17, 2021
• Last Update Submitted That Met QC Criteria: May 14, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: CLR_16_31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No