Inflammation and Pain Associated With Ocular Surgery Clinical Trial
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.
| Verified date | May 2021 |
| Source | Sun Pharma Advanced Research Company Limited |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 325 |
| Est. completion date | March 5, 2020 |
| Est. primary completion date | March 5, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | SPARC Site 19 | Austin | Texas |
| United States | SPARC Site 13 | Chandler | Arizona |
| United States | SPARC Site 08 | Colorado Springs | Colorado |
| United States | SPARC Site 06 | Coral Springs | Florida |
| United States | SPARC Site 17 | Fargo | North Dakota |
| United States | SPARC site 01 | Fayetteville | Arkansas |
| United States | SPARC Site 18 | Fort Myers | Florida |
| United States | SPARC Site 09 | Henderson | Nevada |
| United States | SPARC Site 16 | Jacksonville | Florida |
| United States | SPARC Site 14 | Mesa | Arizona |
| United States | SPARC Site 07 | Miami | Florida |
| United States | SPARC Site 2 | Mission | Texas |
| United States | SPARC Site 15 | Paducah | Kentucky |
| United States | SPARC Site 03 | Poughkeepsie | New York |
| United States | SPARC Site 11 | Prescott | Arizona |
| United States | SPARC Site 05 | Saint Joseph | Michigan |
| United States | SPARC Site 10 | Santa Barbara | California |
| United States | SPARC Site 12 | Sun City | Arizona |
| United States | SPARC Site 04 | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Sun Pharma Advanced Research Company Limited |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) |
Day 15 | |
| Secondary | 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. | Day 15 |