Inflammation and Pain Associated With Ocular SurgeryPhase 3NCT03426267
Evaluation of Efficacy and Safety of SDN-037
A Phase 3 study testing SDN-037 in people with Inflammation and Pain Associated With Ocular Surgery, run by Sun Pharma Advanced Research Company Limited at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation and Pain Associated With Ocular Surgery
- What is being tested?
- SDN-037
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 325 participants
- Where
- 19 sitesUnited States
- Study dates
- 28 Sep 2018to 5 Mar 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
SPARC Site 19
Austin, Texas, 78731
SPARC Site 13
Chandler, Arizona, 85224
SPARC Site 08
Colorado Springs, Colorado, 80919
SPARC Site 06
Coral Springs, Florida, 33067
SPARC Site 17
Fargo, North Dakota, 58103
SPARC site 01
Fayetteville, Arkansas, 72704
SPARC Site 18
Fort Myers, Florida, 33901
SPARC Site 09
Henderson, Nevada, 89052
SPARC Site 16
Jacksonville, Florida, 32204
SPARC Site 14
Mesa, Arizona, 85208
SPARC Site 07
Miami, Florida, 33143
SPARC Site 2
Mission, Texas, 78572
SPARC Site 15
Paducah, Kentucky, 42001
SPARC Site 03
Poughkeepsie, New York, 12603
SPARC Site 11
Prescott, Arizona, 86301
SPARC Site 05
Saint Joseph, Michigan, 49085
SPARC Site 10
Santa Barbara, California, 93110
SPARC Site 12
Sun City, Arizona, 85351
SPARC Site 04
Winston-Salem, North Carolina, 27101
About this study
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.
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.
- Being tested
- SDN-037, Placebo
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDN-037Drug
twice daily
PlaceboDrug
twice daily
| Study group | Role | What they receive |
|---|---|---|
| SDN-037 | Experimental | Not described Receives: Drug: SDN-037 |
| vehicle | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 15
Secondary outcomes (1)
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.
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start28 Sep 2018
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Inflammation and Pain Associated With Ocular SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharma Advanced Research Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426267
- Sponsor's protocol ID
- CLR_16_31
- Status last verified
- May 2021
- First submitted
- 2 Feb 2018
- Last updated
- 17 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03426267
- Acronym / sponsor ID
- CLR_16_31
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 8 Feb 2018 (actual)
- Results
- Posted 17 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDN-037 | Experimental | Drug: SDN-037 |
| vehicle | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SDN-037twice daily | Drug | SDN-037 |
| Placebotwice daily | Drug | vehicle |
Primary outcome
Subjects With an Anterior Chamber Cell Grade of 0 at Day 15
Time frame: 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)
1 secondary outcome
Subjects Who Achieve a Pain Score of 0 at Day 15
Time frame: Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SDN-037 in people with Inflammation and Pain Associated With Ocular Surgery, run by Sun Pharma Advanced Research Company Limited at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects With an Anterior Chamber Cell Grade of 0 at Day 15 (time frame: Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2021.