Clinical trial NCT03426267: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammation and Pain Associated With Ocular Surgery
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2018-02-08
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Subjects With an Anterior Chamber Cell Grade of 0 at Day 15
timeFrame: Day 15
Secondary outcomes:
measure: Subjects Who Achieve a Pain Score of 0 at Day 15
timeFrame: Day 15
Other outcomes:
Locations:
city: Chandler
country: United States
facility: SPARC Site 13
state: Arizona
city: Mesa
country: United States
facility: SPARC Site 14
state: Arizona
city: Prescott
country: United States
facility: SPARC Site 11
state: Arizona
city: Sun City
country: United States
facility: SPARC Site 12
state: Arizona
city: Fayetteville
country: United States
facility: SPARC site 01
state: Arkansas
city: Santa Barbara
country: United States
facility: SPARC Site 10
state: California
city: Colorado Springs
country: United States
facility: SPARC Site 08
state: Colorado
city: Coral Springs
country: United States
facility: SPARC Site 06
state: Florida
city: Fort Myers
country: United States
facility: SPARC Site 18
state: Florida
city: Jacksonville
country: United States
facility: SPARC Site 16
state: Florida
city: Miami
country: United States
facility: SPARC Site 07
state: Florida
city: Paducah
country: United States
facility: SPARC Site 15
state: Kentucky
city: Saint Joseph
country: United States
facility: SPARC Site 05
state: Michigan
city: Henderson
country: United States
facility: SPARC Site 09
state: Nevada
city: Poughkeepsie
country: United States
facility: SPARC Site 03
state: New York
city: Winston-Salem
country: United States
facility: SPARC Site 04
state: North Carolina
city: Fargo
country: United States
facility: SPARC Site 17
state: North Dakota
city: Austin
country: United States
facility: SPARC Site 19
state: Texas
city: Mission
country: United States
facility: SPARC Site 2
state: Texas
Study officials:
References: