Post Ocular Surgical Inflammation and PainPhase 3NCT02034019
Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
A Phase 3 study testing Dexamethasone and Punctum Plug in people with Post Ocular Surgical Inflammation and Pain, run by Ocular Therapeutix, Inc. at 1 site in United States.
Trial summary
To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Ocular Surgical Inflammation and Pain
- What is being tested?
- Dexamethasone and Punctum Plug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 247 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Feb 2015
- 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
- Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens
- Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes
Who cannot join
- Any intraocular inflammation in the study eye present during the screening slit lamp examination
- Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening
- Any intraocular inflammation in the study eye present during the screening slit lamp examination
Trial locations and contacts
1 site in 1 country.
United States1 site
Texan Eye / Keystone Research, Ltd.
Austin, Texas, 78731
About this study
To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.
- Being tested
- Dexamethasone, Punctum Plug
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Punctum PlugDrug
| Study group | Role | What they receive |
|---|---|---|
| OTX-DP (Dexamethasone Punctum Plug) | Active comparator | Resorbable hydrogel drug delivery vehicle containing dexamethasone Receives: Drug: Dexamethasone; Drug: Punctum Plug |
| PVPP (Placebo Punctum Plug) | Placebo comparator | Resorbable hydrogel drug delivery vehicle containing no drug Receives: Drug: Punctum Plug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of Cells in Anterior Chamber of the Study Eye
Measured: Day 14
Absence of Pain in Study Eye
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionFeb 2015
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 Post Ocular Surgical Inflammation and PainStudies 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, Investigator
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocular Therapeutix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Project Manager, Study director, Ocular Therapeutix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034019
- Sponsor's protocol ID
- OTX-13-002
- Status last verified
- Jan 2020
- First submitted
- 9 Jan 2014
- Last updated
- 31 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
- ClinicalTrials.gov ID
- NCT02034019
- Acronym / sponsor ID
- OTX-13-002
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Ocular Therapeutix, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 13 Jan 2014 (estimated)
- Results
- Posted 31 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OTX-DP (Dexamethasone Punctum Plug) | Active comparator | Drug: Dexamethasone, Drug: Punctum PlugResorbable hydrogel drug delivery vehicle containing dexamethasone |
| PVPP (Placebo Punctum Plug) | Placebo comparator | Drug: Punctum PlugResorbable hydrogel drug delivery vehicle containing no drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens
- Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes
Key exclusion criteria (3 listed)
- Any intraocular inflammation in the study eye present during the screening slit lamp examination
- Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening
- Any intraocular inflammation in the study eye present during the screening slit lamp examination
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 |
|---|---|---|
| Dexamethasone | Drug | OTX-DP (Dexamethasone Punctum Plug) |
| Punctum Plug | Drug | OTX-DP (Dexamethasone Punctum Plug), PVPP (Placebo Punctum Plug) |
Primary outcome
Absence of Cells in Anterior Chamber of the Study Eye
Time frame: Day 14
Absence of Pain in Study Eye
Time frame: Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Post Ocular Surgical Inflammation and Pain
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A Phase 3 Study Evaluating the Safety and Efficacy of TRIESENCE® (Injectable Suspension) for the Treatment of Ocular Inflammation and Pain After Ophthalmic Surgery
Postoperative Ocular Inflammation, Postoperative Ocular Pain
RecruitingPhase 4
Dextenza in the Post-op Management of Vitreoretinal Surgeries
Vitreoretinal Surgery, Ocular Inflammation
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.
Clinical Project Manager study director
Ocular Therapeutix
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 Dexamethasone and Punctum Plug in people with Post Ocular Surgical Inflammation and Pain, 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 3 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 31 Jan 2020. 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. 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 31 Jan 2020). 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?
Absence of Cells in Anterior Chamber of the Study Eye (time frame: Day 14). The study lists 2 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 31 Jan 2020.