NCT03426267

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
325

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

September 28, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 17, 2021

Completed
Last Updated

May 17, 2021

Status Verified

May 1, 2021

Enrollment Period

1.4 years

First QC Date

February 2, 2018

Results QC Date

March 3, 2021

Last Update Submit

May 14, 2021

Conditions

Inflammation and Pain Associated With Ocular Surgery

Outcome Measures

Primary Outcomes (1)

  • Subjects With an Anterior Chamber Cell Grade of 0 at 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)

    Day 15

Secondary Outcomes (1)

  • Subjects Who Achieve a Pain Score of 0 at Day 15

    Day 15

Study Arms (2)

SDN-037

EXPERIMENTAL
Drug: SDN-037

vehicle

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SDN-037DRUG

twice daily

SDN-037
PlaceboDRUG

twice daily

vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

SPARC Site 13

Chandler, Arizona, 85224, United States

Location

SPARC Site 14

Mesa, Arizona, 85208, United States

Location

SPARC Site 11

Prescott, Arizona, 86301, United States

Location

SPARC Site 12

Sun City, Arizona, 85351, United States

Location

SPARC site 01

Fayetteville, Arkansas, 72704, United States

Location

SPARC Site 10

Santa Barbara, California, 93110, United States

Location

SPARC Site 08

Colorado Springs, Colorado, 80919, United States

Location

SPARC Site 06

Coral Springs, Florida, 33067, United States

Location

SPARC Site 18

Fort Myers, Florida, 33901, United States

Location

SPARC Site 16

Jacksonville, Florida, 32204, United States

Location

SPARC Site 07

Miami, Florida, 33143, United States

Location

SPARC Site 15

Paducah, Kentucky, 42001, United States

Location

SPARC Site 05

Saint Joseph, Michigan, 49085, United States

Location

SPARC Site 09

Henderson, Nevada, 89052, United States

Location

SPARC Site 03

Poughkeepsie, New York, 12603, United States

Location

SPARC Site 04

Winston-Salem, North Carolina, 27101, United States

Location

SPARC Site 17

Fargo, North Dakota, 58103, United States

Location

SPARC Site 19

Austin, Texas, 78731, United States

Location

SPARC Site 2

Mission, Texas, 78572, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Head-Clinical Development
Organization
Sun Pharma Advanced Research Company Limited
clinical.trials@sparcmail.com
912266455645

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2018

First Posted

February 8, 2018

Study Start

September 28, 2018

Primary Completion

March 5, 2020

Study Completion

March 5, 2020

Last Updated

May 17, 2021

Results First Posted

May 17, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(19)