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Trial record 1 of 1 for:    SDN-037 | ocular surgery
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Evaluation of Efficacy and Safety of SDN-037

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03426267
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : June 12, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Inflammation and Pain Associated With Ocular Surgery Drug: SDN-037 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 386 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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.
Actual Study Start Date : September 28, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : January 30, 2020

Arm Intervention/treatment
Experimental: SDN-037 Drug: SDN-037
twice daily

Placebo Comparator: vehicle Drug: Placebo
twice daily

Primary Outcome Measures :
  1. proportion of subjects with an anterior chamber cell grade of 0 at Day 15 [ Time Frame: Day 15 ]

Secondary Outcome Measures :
  1. the proportion of subjects who achieve a pain score of 0 at Day 15 [ Time Frame: Day 15 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03426267

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Contact: Head, Clinical development 912266455645

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United States, Arizona
SPARC Site 13 Not yet recruiting
Chandler, Arizona, United States, 85224
Contact: Dr. Michael Depenbusch, MD    480-999-5458   
SPARC Site 14 Not yet recruiting
Mesa, Arizona, United States, 85208
Contact: Dr. Tariq Qamar, MD    480-999-5458   
SPARC Site 11 Suspended
Prescott, Arizona, United States, 86301
SPARC Site 12 Recruiting
Sun City, Arizona, United States, 85351
Contact: Dr. Gerald Walman, MD    480-999-5458   
United States, Arkansas
SPARC site 01 Suspended
Fayetteville, Arkansas, United States, 72704
United States, California
SPARC Site 10 Not yet recruiting
Santa Barbara, California, United States, 93110
Contact: Dr. Douglas Katsev, MD    480-999-5458   
United States, Colorado
SPARC Site 08 Recruiting
Colorado Springs, Colorado, United States, 80919
Contact: Dr Michael G Haas, MD    480-999-5458,   
United States, Florida
SPARC Site 06 Active, not recruiting
Coral Springs, Florida, United States, 33067
SPARC Site 18 Recruiting
Fort Myers, Florida, United States, 33901
Contact: Dr. Stephen Smith, MD    239-939-0413   
SPARC Site 16 Not yet recruiting
Jacksonville, Florida, United States, 32204
Contact: Dr Frank McDonald, MD    904-366-3781 ext 2215   
SPARC Site 07 Not yet recruiting
Miami, Florida, United States, 33143
Contact: Dr. Segal , MD    305-661-8588 ext 1810   
United States, Kentucky
SPARC Site 15 Not yet recruiting
Paducah, Kentucky, United States, 42001
Contact: Dr Mark Gillespie, MD    270-443-4393   
United States, Michigan
SPARC Site 05 Suspended
Saint Joseph, Michigan, United States, 49085
United States, Nevada
SPARC Site 09 Suspended
Henderson, Nevada, United States, 89052
United States, New York
SPARC Site 03 Suspended
Poughkeepsie, New York, United States, 12603
United States, North Carolina
SPARC Site 04 Not yet recruiting
Winston-Salem, North Carolina, United States, 27101
Contact: Dr. James D Branch, MD    480-999-5458   
United States, North Dakota
SPARC Site 17 Recruiting
Fargo, North Dakota, United States, 58103
Contact: Dr. Lance Bergstrom, MD    701-478-0061   
United States, Texas
SPARC Site 19 Recruiting
Austin, Texas, United States, 78731
Contact: Dr. Thomas Walters, MD    512-451-4400   
SPARC Site 2 Active, not recruiting
Mission, Texas, United States, 78572
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited

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Responsible Party: Sun Pharma Advanced Research Company Limited Identifier: NCT03426267     History of Changes
Other Study ID Numbers: CLR_16_31
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pathologic Processes