Ocular Inflammation and PainPhase 2NCT01666210
Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
A Phase 2 study testing OTX-DP (Dexamethasone punctum plug) in people with Ocular 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 ocular 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 21 years and older
- Conditions the study is for
- Ocular Inflammation and Pain
- What is being tested?
- OTX-DP (Dexamethasone punctum plug)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Aug 2013
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has provided written informed consent, approved by the appropriate institutional review board; and is able to comply with study requirements and visit schedule
- Is greater than or equal to 21 years of age
- Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens
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 at Screening
- Compromised immune system or an autoimmune disease that in the opinion of the Investigator could affect the quality of the ocular surface
Trial locations and contacts
1 site in 1 country.
United States1 site
Chicago Cornea Consultants, Ltd.
Hoffman Estates, Illinois, 60169
About this study
Official title: A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase II Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
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 ocular inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.
- Conditions
- Ocular Inflammation and Pain
- Being tested
- OTX-DP (Dexamethasone punctum plug), Placebo Vehicle 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.
OTX-DP (Dexamethasone punctum plug)Drug
Sustained and tapered release of dexamethasone from hydrogel punctum plug
Placebo Vehicle Punctum PlugDrug
Hydrogel punctum plug without dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Punctum Plug | Active comparator | Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days Receives: Drug: OTX-DP (Dexamethasone punctum plug) |
| Placebo Vehicle Punctum Plug | Placebo comparator | Placebo punctum plug insertion Receives: Drug: Placebo Vehicle 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 Study Eye
Measured: Day 8
Absence of Pain in the 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 posted16 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2013
- Study completionAug 2013
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 Ocular 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 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
- NCT01666210
- Sponsor's protocol ID
- OTX-12-002
- Status last verified
- Sep 2021
- First submitted
- 14 Aug 2012
- Last updated
- 19 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase II Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
- ClinicalTrials.gov ID
- NCT01666210
- Acronym / sponsor ID
- OTX-12-002
- Conditions
- Ocular Inflammation and Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ocular Therapeutix, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012 (actual)
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 16 Aug 2012 (estimated)
- Results
- Posted 27 Apr 2017
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 ocular 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 |
|---|---|---|
| Dexamethasone Punctum Plug | Active comparator | Drug: OTX-DP (Dexamethasone punctum plug)Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days |
| Placebo Vehicle Punctum Plug | Placebo comparator | Drug: Placebo Vehicle Punctum PlugPlacebo punctum plug insertion |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has provided written informed consent, approved by the appropriate institutional review board; and is able to comply with study requirements and visit schedule
- Is greater than or equal to 21 years of age
- Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens
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 at Screening
- Compromised immune system or an autoimmune disease that in the opinion of the Investigator could affect the quality of the ocular surface
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 |
|---|---|---|
| OTX-DP (Dexamethasone punctum plug)Sustained and tapered release of dexamethasone from hydrogel punctum plug | Drug | Dexamethasone Punctum Plug |
| Placebo Vehicle Punctum PlugHydrogel punctum plug without dexamethasone | Drug | Placebo Vehicle Punctum Plug |
Primary outcome
Absence of Cells in Anterior Chamber of Study Eye
Time frame: Day 8
Absence of Pain in the 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 19 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OTX-DP (Dexamethasone punctum plug) in people with Ocular 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 3 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 19 Oct 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 27 Apr 2017). 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 Study Eye (time frame: Day 8). 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 19 Oct 2021.