CataractPhase 4NCT04687800
Clinical Investigation of the Dextenza 0.4mg Intracanalicular Insert Delivery System Used in Cataract Surgery
A Phase 4 study testing Dextenza 0.4mg intracanalicular Insert and Durezol 0.05% Ophthalmic Emulsion in people with Cataract, run by Cathleen McCabe MD at 1 site in United States.
Trial summary
To monitor intraocular pressure in glaucoma patients after cataract surgery preformed in conjunction with minimally invasive glaucoma surgery (MIGS) Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cataract
- What is being tested?
- Dextenza 0.4mg intracanalicular Insert and Durezol 0.05% Ophthalmic Emulsion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 24 Oct 2022
- Phase
- Phase 4
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or Older
- Mild-to-moderate primary open angle glaucoma and visually significant cataract with plans to undergo clear cornea cataract surgery with Phacoemulsification and implantation of posterior chamber IOL combined with minimally invasive glaucoma surgery ( MIGS) procedure in both eyes.
Who cannot join
- Use of Topical steroid, systemic steroid or intravitreal steroid implants within last 3 months
- Previous Corneal surgery or pathology
- Active or history of chronic or recurrent inflammatory eye disease in either eye
- Ocular Pain in either eye
- Proliferative diabetic retinopathy in either eye
- Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye.
Show all 11Show fewer
- Laser or incisional ocular surgery during the study period and 6 months prior in either eye
- Systemic concomitant pain medication management with the pharmacology class of Oxycodone
- Systemic NSAIDS use >/=750 mg daily
- Clinically significant macular edema
- History of cystoid macular edema in either eye
Trial locations and contacts
1 site in 1 country.
United States1 site
The Eye Associates of Manatee
Bradenton, Florida, 34209
About this study
Official title: A Randomized, Clinical Investigation of the Dextenza 0.4mg Intracanalicular Insert Delivery System Used in Conjunction With Cataract Surgery Performed in Combination With Minimally Invasive Glaucoma Surgery
To monitor intraocular pressure in glaucoma patients after cataract surgery preformed in conjunction with minimally invasive glaucoma surgery (MIGS)
Read the detailed description
The purpose of this study is to monitor glaucoma patients intraocular pressure (IOP) after cataract surgery performed in conjunction with minimally invasive glaucoma surgery. After qualifying for this study, subjects will be randomized in a 1:1 allocation of one of two arms. The purpose of this study is to determine if Dextenza (dexamethasone) 0.4mg intracanalicular insert delivery system, provides a decreased risk of elevated post-operative IOP vs. standard therapy controlled topical steroid Durezol (Difluprednate ophthalmic emulsion) 0.05%
- Conditions
- Cataract
- Being tested
- Dextenza 0.4mg intracanalicular Insert, Durezol 0.05% Ophthalmic Emulsion
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextenza 0.4mg intracanalicular InsertDrug
Also called dexamethasone ophthalmic insert
intracanalicular insert delivery system
Durezol 0.05% Ophthalmic EmulsionDrug
Also called difluprednate ophthalmic
Standard therapy, topical steroid drop
| Study group | Role | What they receive |
|---|---|---|
| Dextenza 0.4mg | Experimental | Intracanalicular insert Receives: Drug: Dextenza 0.4mg intracanalicular Insert |
| Durezol 0.05% | Active comparator | difluprednate ophthalmic emulsion Receives: Drug: Durezol 0.05% Ophthalmic Emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intraocular Pressure from Baseline
Sustained tapered release of Dextenza compared to Durezol 4 week taper as measured by mean IOP from baseline.
Measured: 30 days - IOP measured at day 1, day 14 and day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Dec 2020
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
Why it stopped: Inability to enroll due to lack of access to the Ambulatory Surgery Center.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Open label prospective randomized comparative investigator -initiated study
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cathleen McCabe MD
- Sponsor type
- University, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Responsible party
- Sponsor-investigator, Cathleen McCabe MD, The Eye Associates
- Investigators
- Cathleen M McCabe, MD, Principal investigator, The Eye Associates of Manatee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687800
- Sponsor's protocol ID
- The McTENZA Study
- Status last verified
- Nov 2022
- First submitted
- 8 Dec 2020
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Clinical Investigation of the Dextenza 0.4mg Intracanalicular Insert Delivery System Used in Conjunction With Cataract Surgery Performed in Combination With Minimally Invasive Glaucoma Surgery
- ClinicalTrials.gov ID
- NCT04687800
- Acronym / sponsor ID
- The McTENZA Study
- Conditions
- Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to enroll due to lack of access to the Ambulatory Surgery Center.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Cathleen McCabe MDUniversity, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 29 Dec 2020 (actual)
- 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.
To monitor intraocular pressure in glaucoma patients after cataract surgery preformed in conjunction with minimally invasive glaucoma surgery (MIGS)
Detailed description
The purpose of this study is to monitor glaucoma patients intraocular pressure (IOP) after cataract surgery performed in conjunction with minimally invasive glaucoma surgery. After qualifying for this study, subjects will be randomized in a 1:1 allocation of one of two arms. The purpose of this study is to determine if Dextenza (dexamethasone) 0.4mg intracanalicular insert delivery system, provides a decreased risk of elevated post-operative IOP vs. standard therapy controlled topical steroid Durezol (Difluprednate ophthalmic emulsion) 0.05%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label prospective randomized comparative investigator -initiated study
| Arm | Type | Receives |
|---|---|---|
| Dextenza 0.4mg | Experimental | Drug: Dextenza 0.4mg intracanalicular InsertIntracanalicular insert |
| Durezol 0.05% | Active comparator | Drug: Durezol 0.05% Ophthalmic Emulsiondifluprednate ophthalmic emulsion |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or Older
- Mild-to-moderate primary open angle glaucoma and visually significant cataract with plans to undergo clear cornea cataract surgery with Phacoemulsification and implantation of posterior chamber IOL combined with minimally invasive glaucoma surgery ( MIGS) procedure in both eyes.
Key exclusion criteria (11 listed)
- Use of Topical steroid, systemic steroid or intravitreal steroid implants within last 3 months
- Previous Corneal surgery or pathology
- Active or history of chronic or recurrent inflammatory eye disease in either eye
- Ocular Pain in either eye
- Proliferative diabetic retinopathy in either 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 |
|---|---|---|
| Dextenza 0.4mg intracanalicular InsertAlso: dexamethasone ophthalmic insertintracanalicular insert delivery system | Drug | Dextenza 0.4mg |
| Durezol 0.05% Ophthalmic EmulsionAlso: difluprednate ophthalmicStandard therapy, topical steroid drop | Drug | Durezol 0.05% |
Primary outcome
Mean Intraocular Pressure from Baseline
Time frame: 30 days - IOP measured at day 1, day 14 and day 30
Sustained tapered release of Dextenza compared to Durezol 4 week taper as measured by mean IOP from baseline.
Results and safety
The study was stopped early (reason given: Inability to enroll due to lack of access to the Ambulatory Surgery Center.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Sponsor/ site websiteLink provided by the sponsor.
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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.
Cathleen M McCabe, MD principal investigator
The Eye Associates of Manatee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dextenza 0.4mg intracanalicular Insert and Durezol 0.05% Ophthalmic Emulsion in people with Cataract, run by Cathleen McCabe MD 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 11 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: stopped early, as of the sponsor's last update on 10 Nov 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Inability to enroll due to lack of access to the Ambulatory Surgery Center.). Results are not available in the source record.
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?
Mean Intraocular Pressure from Baseline (time frame: 30 days - IOP measured at day 1, day 14 and day 30). 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 10 Nov 2022.