Cataract Surgery Incision LeakPhase 3NCT01498224
ReSure Sealant Pivotal Study
A Phase 3 study testing ReSure Sealant and Sutures in people with Cataract Surgery Incision Leak, run by Ocular Therapeutix, Inc. at 1 site in United States.
Trial summary
This is a randomized multicenter study to evaluate the safety and effectiveness of ReSure Sealant compared to sutures for preventing incision leakage within the first 7 days of cataract surgery. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataract Surgery Incision Leak
- What is being tested?
- ReSure Sealant and Sutures
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Nov 2012
- Phase
- Phase 3
- 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
Who may be able to join
- Subject has a cataract and is expected to undergo clear cornea cataract surgery with phacoemulsification and implantation of posterior chamber intraocular lens
- Subject must be 22 years of age or older
Who cannot join
- Any intraocular inflammation in study eye or presence of ocular pain in operative eye at preoperative assessment
- Previous corneal or retinal surgery or planned multiple procedures during cataract surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Levenson Eye Associates
Jacksonville, Florida, 32204
About this study
This is a randomized multicenter study to evaluate the safety and effectiveness of ReSure Sealant compared to sutures for preventing incision leakage within the first 7 days of cataract surgery.
- Conditions
- Cataract Surgery Incision Leak
- Being tested
- ReSure Sealant, Sutures
- Keywords
- Cataract surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReSure SealantDevice
Comparison of ReSure Sealant to suture(s)
SuturesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Suture | Active comparator | Suture application Receives: Procedure: Sutures |
| ReSure Sealant | Experimental | Sealant application Receives: Device: ReSure Sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eyes with any clear corneal incision/suture leakage as determined by positive Seidel test indicating fluid egress within first 7 days after surgery.
Measured: Days 1-28
Secondary outcomes (3)
Foreign Body Sensation
Measured: Days 1-28
Best corrected visual acuity
Best corrected visual acuity worse than 20/40 at day 1
Measured: Day 1
Best corrected visual acuity
Best corrected visual acuity worse than 20/40 at 28 days
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract Surgery Incision LeakStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 488 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
- NCT01498224
- Sponsor's protocol ID
- OTX-11-002
- Status last verified
- Feb 2016
- First submitted
- 18 Dec 2011
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data is available on FDA website for approved PMA P130004
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReSure Sealant Pivotal Study
- ClinicalTrials.gov ID
- NCT01498224
- Acronym / sponsor ID
- OTX-11-002
- Conditions
- Cataract Surgery Incision Leak
- Keywords
- Cataract surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- Ocular Therapeutix, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 23 Dec 2011 (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 randomized multicenter study to evaluate the safety and effectiveness of ReSure Sealant compared to sutures for preventing incision leakage within the first 7 days of cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suture | Active comparator | Procedure: SuturesSuture application |
| ReSure Sealant | Experimental | Device: ReSure SealantSealant application |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has a cataract and is expected to undergo clear cornea cataract surgery with phacoemulsification and implantation of posterior chamber intraocular lens
- Subject must be 22 years of age or older
Key exclusion criteria (2 listed)
- Any intraocular inflammation in study eye or presence of ocular pain in operative eye at preoperative assessment
- Previous corneal or retinal surgery or planned multiple procedures during cataract surgery.
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 SealantComparison of ReSure Sealant to suture(s) | Device | ReSure Sealant |
| Sutures | Procedure or surgery | Suture |
Primary outcome
Proportion of eyes with any clear corneal incision/suture leakage as determined by positive Seidel test indicating fluid egress within first 7 days after surgery.
Time frame: Days 1-28
3 secondary outcomes
Foreign Body Sensation
Time frame: Days 1-28
Best corrected visual acuity
Time frame: Day 1
Best corrected visual acuity
Time frame: Day 28
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 12 Dec 2016.
- Publications of study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data is available on FDA website for approved PMA P130004
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ReSure Sealant and Sutures in people with Cataract Surgery Incision Leak, run by Ocular Therapeutix, Inc. at 1 site 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 2 inclusion and 2 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 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
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?
Proportion of eyes with any clear corneal incision/suture leakage as determined by positive Seidel test indicating fluid egress within first 7 days after surgery. (time frame: Days 1-28). 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 12 Dec 2016.