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Completed

NCT Number: NCT03426267

Evaluation of Efficacy and Safety of SDN-037

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.

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Key information

Conditions

Inflammation and Pain Associated With Ocular Surgery Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

SPARC Site 13, Chandler, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SDN-037

Drug

twice daily

Placebo

Drug

twice daily

Primary outcomes

  1. Subjects With an Anterior Chamber Cell Grade of 0 at Day 15

    Time frame: 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 outcomes

  1. Subjects Who Achieve a Pain Score of 0 at Day 15

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sun Pharma Advanced Research Company Limited

Industry

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 8, 2018
Registry last updated
May 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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