Chronic Allergic ConjunctivitisPhase 3NCT02445326
OTX-14-007: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
A Phase 3 study testing Dexamethasone in people with Chronic Allergic Conjunctivitis, run by Ocular Therapeutix, Inc..
Trial summary
The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Allergic Conjunctivitis
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen
- Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation
Who cannot join
- History of refractive surgery (including LASIK procedures)
- History of retinal detachment, diabetic retinopathy, or active retinal disease
- Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
- Use any of the disallowed medications during the period indicated
- History of IOP increase as a result of steroid treatment
About this study
Official title: A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 3 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (CAC®)
The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis
- Conditions
- Chronic Allergic Conjunctivitis
- Being tested
- Dexamethasone, Placebo Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Placebo VehicleOther
| Study group | Role | What they receive |
|---|---|---|
| OTX-DP | Experimental | OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use Receives: Drug: Dexamethasone |
| PV | Placebo comparator | PV (placebo drug delivery vehicle) Receives: Other: Placebo Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
Measured: 3 minutes
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
Measured: 5 minutes
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
Measured: 7 minutes
Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
Measured: 7 minutes
Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
Measured: 15 minutes
Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2015
- Study completionSep 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 Chronic Allergic ConjunctivitisStudies 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocular Therapeutix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445326
- Sponsor's protocol ID
- OTX-14-007
- Status last verified
- Mar 2018
- First submitted
- 13 May 2015
- Last updated
- 29 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 3 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (CAC®)
- ClinicalTrials.gov ID
- NCT02445326
- Acronym / sponsor ID
- OTX-14-007
- Conditions
- Chronic Allergic Conjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Ocular Therapeutix, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- Apr 2015 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Posted 29 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis
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 | Experimental | Drug: DexamethasoneOTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use |
| PV | Placebo comparator | Other: Placebo VehiclePV (placebo drug delivery vehicle) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen
- Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation
Key exclusion criteria (5 listed)
- History of refractive surgery (including LASIK procedures)
- History of retinal detachment, diabetic retinopathy, or active retinal disease
- Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
- Use any of the disallowed medications during the period indicated
- History of IOP increase as a result of steroid treatment
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 |
| Placebo Vehicle | Other | PV |
Primary outcome
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Time frame: 3 minutes
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Time frame: 5 minutes
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Time frame: 7 minutes
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Time frame: 7 minutes
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Time frame: 15 minutes
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Time frame: 20 minutes
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone in people with Chronic Allergic Conjunctivitis, 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 2 inclusion and 5 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 29 Mar 2018. 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. 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 29 Mar 2018). 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?
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 (time frame: 3 minutes). The study lists 6 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 29 Mar 2018.