A Phase 3 interventional study of SDN-037 and Placebo in Inflammation and Pain Associated With Ocular Surgery, sponsored by Sun Pharma Advanced Research Company Limited. Completed at 19 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-17.
Sponsored by Sun Pharma Advanced Research Company Limited (formerly part of Sun Pharmaceutical Industries Limited) · Phase 3, Interventional, and Treatment
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.
3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.
This study's enrollment of 325 is above the median of 50 across 2,577 interventional studies indexed under Inflammation.
Browse Inflammation studies →Sun Pharma Advanced Research Company Limited is the lead sponsor of 35 studies on the registry; 2 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 4 (31%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: SDN-037
Drug: Placebo
twice daily
twice daily
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)
Time frame: Day 15
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.
Time frame: Day 15
| Milestone | SDN-037 | Vehicle |
|---|---|---|
| Started | 163 | 162 |
| Modified intent-to-treat population | 154 | 144 |
| Completed | 142 | 90 |
| Not completed | 21 | 72 |
| Withdrew: Physician decision | 1 | 4 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Withdrawal by subject | 4 | 10 |
| Withdrew: Protocol violation | 1 | 3 |
| Withdrew: Adverse event | 9 | 27 |
| Withdrew: Prohibited treatment intake | 2 | 3 |
| Withdrew: Lack of efficacy | 0 | 25 |
| Withdrew: Other | 3 | 0 |
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)
| Participants | SDN-037 | Vehicle |
|---|---|---|
| Subjects With an Anterior Chamber Cell Grade of 0 at Day 15 | 96 | 30 |
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.
| Participants | SDN-037 | Vehicle |
|---|---|---|
| Subjects Who Achieve a Pain Score of 0 at Day 15 | 151 | 106 |
Collected over Up to 6 visits over a period of 22 to 36 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SDN-037 | 0/154 (0%) | 2/154 (1.3%) | 87/154 (56.5%) |
| Vehicle | 0/144 (0%) | 2/144 (1.4%) | 96/144 (66.7%) |
| Event | SDN-037 | Vehicle |
|---|---|---|
| Rhegmatogenous Retinal Detachment In Study EyeEye disorders | 0/154 | 1/144 |
| Cystoid Macula EdemaEye disorders | 1/154 | 1/144 |
| Left Foot Infection Secondary To TraumaInfections and infestations | 1/154 | 0/144 |
| Event | SDN-037 | Vehicle |
|---|---|---|
| Anterior chamber cellEye disorders | 26/154 | 35/144 |
| Anterior chamber flareEye disorders | 15/154 | 31/144 |
| Visual acuity reducedEye disorders | 14/154 | 30/144 |
| Conjunctival hyperaemiaEye disorders | 5/154 | 22/144 |
| Corneal oedemaEye disorders | 6/154 | 20/144 |
| Intraocular pressure increasedInvestigations | 17/154 | 7/144 |
| Eye painEye disorders | 10/154 | 14/144 |
| PhotophobiaEye disorders | 6/154 | 10/144 |
modified intent-to-treat population
| Age, Continuous(years) | SDN-037 | Vehicle | Total |
|---|---|---|---|
| Mean | 68.3 ± 8.61 | 68.3 ± 8.94 | 68.3 ± 8.76 |
| Sex: Female, Male(Participants) | SDN-037 | Vehicle | Total |
|---|---|---|---|
| Female | 94 | 84 | 178 |
| Male | 60 | 60 | 120 |
| Ethnicity (NIH/OMB)(Participants) | SDN-037 | Vehicle | Total |
|---|---|---|---|
| Hispanic or Latino | 39 | 42 | 81 |
| Not Hispanic or Latino | 114 | 102 | 216 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | SDN-037 | Vehicle | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 3 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 34 | 31 | 65 |
| White | 115 | 109 | 224 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 1 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2018 to primary completion in Mar 2020, 17 months.
Results were first posted in May 2021, 1 year 2 months after primary completion.
Of 21 industry-sponsored phase 3 interventional studies under Inflammation, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 28. This study's 17 months is below that.
Counting every sponsor, half of 68 studies reached it within 27 months; a quarter within 17 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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