Adverse EventsClinical PASNCT02310815
ReSure Sealant Post Approval Study
An observational study of Adverse Events, run by Ocular Therapeutix, Inc..
Trial summary
This is a prospective multicenter observational post-approval registry study that will collect post-approval data relative to the incidence of pre-specified Adverse Ocular Events for cataract surgery patients treated with the FDA-approved ReSure Sealant when used by a broad group of physicians under commercial use… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Adverse Events
- What is being tested?
- ReSure Sealant
- Type of treatment
- Medical device
- How many people
- 626 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with ReSure Sealant following cataract surgery
Who may be able to join
- Subject has a cataract and is expected to undergo clear corneal cataract surgery with intraocular lens placement
Who cannot join
- ReSure Sealant is not applied to the operative eye
About this study
Official title: ReSure Sealant Post-Approval Study: A Registry Evaluation of ReSure Sealant for Specified Adverse Ocular Events After Sealing Corneal Incisions in Patients Undergoing Clear Corneal Cataract Surgery
This is a prospective multicenter observational post-approval registry study that will collect post-approval data relative to the incidence of pre-specified Adverse Ocular Events for cataract surgery patients treated with the FDA-approved ReSure Sealant when used by a broad group of physicians under commercial use conditions.
- Conditions
- Adverse Events
- Being tested
- ReSure Sealant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReSure SealantDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior chamber cells greater than level 1+ persisting at Visit 2 (≥ Day 20)
Measured: Post operative days 20 to 40
Hypotony (≤ 5 mmHg)
Measured: Post operative days 20 to 40
Ocular discomfort
Ocular Comfort Index score greater than 51.7 or a within-person increase from baseline of greater than 37.8
Measured: Post operative days 20 to 40
Surgical reintervention
Surgical reintervention for management of a wound leak - Yes or No
Measured: Post operative days 20 to 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionFeb 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse EventsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 626 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocular Therapeutix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310815
- Sponsor's protocol ID
- OTX-13-003
- Acronym
- Clinical PAS
- Status last verified
- Dec 2016
- First submitted
- 3 Dec 2014
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReSure Sealant Post-Approval Study: A Registry Evaluation of ReSure Sealant for Specified Adverse Ocular Events After Sealing Corneal Incisions in Patients Undergoing Clear Corneal Cataract Surgery
- ClinicalTrials.gov ID
- NCT02310815
- Acronym / sponsor ID
- Clinical PAS / OTX-13-003
- Conditions
- Adverse Events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 626 participants (actual)
- Lead sponsor
- Ocular Therapeutix, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective multicenter observational post-approval registry study that will collect post-approval data relative to the incidence of pre-specified Adverse Ocular Events for cataract surgery patients treated with the FDA-approved ReSure Sealant when used by a broad group of physicians under commercial use conditions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with ReSure Sealant following cataract surgery
Key inclusion criteria (1 listed)
- Subject has a cataract and is expected to undergo clear corneal cataract surgery with intraocular lens placement
Key exclusion criteria (1 listed)
- ReSure Sealant is not applied to the operative eye
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 |
|---|---|---|
| ReSure Sealant | Device | – |
Primary outcome
Anterior chamber cells greater than level 1+ persisting at Visit 2 (≥ Day 20)
Time frame: Post operative days 20 to 40
Hypotony (≤ 5 mmHg)
Time frame: Post operative days 20 to 40
Ocular discomfort
Time frame: Post operative days 20 to 40
Ocular Comfort Index score greater than 51.7 or a within-person increase from baseline of greater than 37.8
Surgical reintervention
Time frame: Post operative days 20 to 40
Surgical reintervention for management of a wound leak - Yes or No
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Events, run by Ocular Therapeutix, Inc..
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 1 inclusion and 1 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 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anterior chamber cells greater than level 1+ persisting at Visit 2 (≥ Day 20) (time frame: Post operative days 20 to 40). The study lists 4 primary outcomes in all. 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 5 Dec 2016.