search
Back to results

Evaluation of Efficacy and Safety of SDN-037

Primary Purpose

Inflammation and Pain Associated With Ocular Surgery

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SDN-037
Placebo
Sponsored by
Sun Pharma Advanced Research Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation and Pain Associated With Ocular Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SPARC Site 13
  • SPARC Site 14
  • SPARC Site 11
  • SPARC Site 12
  • SPARC site 01
  • SPARC Site 10
  • SPARC Site 08
  • SPARC Site 06
  • SPARC Site 18
  • SPARC Site 16
  • SPARC Site 07
  • SPARC Site 15
  • SPARC Site 05
  • SPARC Site 09
  • SPARC Site 03
  • SPARC Site 04
  • SPARC Site 17
  • SPARC Site 19
  • SPARC Site 2

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SDN-037

vehicle

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Full Information

First Posted
February 2, 2018
Last Updated
May 14, 2021
Sponsor
Sun Pharma Advanced Research Company Limited
search

1. Study Identification

Unique Protocol Identification Number
NCT03426267
Brief Title
Evaluation of Efficacy and Safety of SDN-037
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
March 5, 2020 (Actual)
Study Completion Date
March 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharma Advanced Research Company Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation and Pain Associated With Ocular Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
325 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SDN-037
Arm Type
Experimental
Arm Title
vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SDN-037
Intervention Description
twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
twice daily
Primary Outcome Measure Information:
Title
Subjects With an Anterior Chamber Cell Grade of 0 at Day 15
Description
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)
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Subjects Who Achieve a Pain Score of 0 at Day 15
Description
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.
Time Frame
Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
SPARC Site 13
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
SPARC Site 14
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85208
Country
United States
Facility Name
SPARC Site 11
City
Prescott
State/Province
Arizona
ZIP/Postal Code
86301
Country
United States
Facility Name
SPARC Site 12
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
SPARC site 01
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72704
Country
United States
Facility Name
SPARC Site 10
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93110
Country
United States
Facility Name
SPARC Site 08
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80919
Country
United States
Facility Name
SPARC Site 06
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
SPARC Site 18
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
SPARC Site 16
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
SPARC Site 07
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
SPARC Site 15
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
SPARC Site 05
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
SPARC Site 09
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
SPARC Site 03
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603
Country
United States
Facility Name
SPARC Site 04
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Facility Name
SPARC Site 17
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
SPARC Site 19
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
SPARC Site 2
City
Mission
State/Province
Texas
ZIP/Postal Code
78572
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Efficacy and Safety of SDN-037

We'll reach out to this number within 24 hrs