CataractPhase 4DEXTENZANCT05372315
Efficacy of Dextenza Insert in Upper vs Lower Punctum Following Cataract Surgery With PCIOL.
A Phase 4 study testing Dextenza 0.4Mg Ophthalmic Insert in people with Cataract, run by Iworks Laser and Vision Center at 1 site in United States.
Trial summary
To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Dextenza 0.4Mg Ophthalmic Insert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 31 Oct 2022
- Phase
- Phase 4
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be eligible for study participation if they:
- Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes with or without iStent/Hydrus/Goniotomy.
- Are willing and able to comply with clinic visits and study related procedures.
- Are willing and able to sign the informed consent form.
- Not pregnant.
Who cannot join
- Subjects are not eligible for study participation if they:
- Are currently being treated with corticosteroid implant (i.e. Ozurdex).
- Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye.
- Have a history of complete punctal occlusion in one or both punctum.
- Currently use topical ophthalmic steroid medications.
- Are unwilling or unable to comply with the study protocol.
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- Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) or if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment.
- Have active infectious systemic disease.
- Have active infectious ocular or extraocular disease.
- Have unobstructed nasolacrimal duct in the study eye(s) (dacrocystitis).
- Have known hypersensitivity to dexamethasone or are a known steroid responder.
- Have a history of ocular inflammation or macular edema.
- Are currently being treated with immunomodulating agents in the study eye(s).
- Are currently being treated with immunosuppressants an/or oral steroids.
- Are Pregnant or breast-feeding or wish to become pregnant during the length of study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment With an Intracanalicular Dexamethasone (0.4mg) Ophthalmic Insert in the Operating Room Following Cataract Surgery/Intraocular Lens Implant (IOL).
To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.
Read the detailed description
This is a randomized, controlled study to evaluate the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.
- Conditions
- Cataract
- Being tested
- Dextenza 0.4Mg Ophthalmic Insert
- Keywords
- PCIOL, CCI CE
- 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 Ophthalmic InsertDrug
(dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Lower Punctum Insertion (Group 1) | Other | DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use
Group 1 (up to 40 eyes) will receive the insert in the lower punctum on the day of surgery in the OR. Receives: Drug: Dextenza 0.4Mg Ophthalmic Insert |
| Upper Punctum Insertion (Group 2) | Other | DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use
Group 2 (up to 40 eyes) will receive the insert in the upper punctum on the of surgery in the OR. Receives: Drug: Dextenza 0.4Mg Ophthalmic Insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Complete Absence of Ocular Pain at Day 8
Participant reported ocular pain on a scale of (0-10) with zero (0) equaling no pain and ten(10) equaling maximal pain on day 8.
Measured: at Day 8
Participants With Zero Cells on Day 14
Proportion of of participants with complete absence of anterior chamber cell at Day 14 as measured by Summed Ocular Inflammation Score (0-4).
Measured: at Day 14
Secondary outcomes (2)
Ease of Insertion
Rated as Easy, Moderate, Difficult
Measured: Day 0
Attempts to Achieve Successful Insertion
Number of attempts to insert the dexamethasone insert in the upper or lower punctum.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start15 Jun 2022
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Sequential
- Model description
- Each subject's participation is expected to last for approximately 1 month and will be required to complete six scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 8, Day 14 and Day 30.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iworks Laser and Vision Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Responsible party
- Principal investigator, Dr. Patrick Spencer, Iworks Laser and Vision Center
- Investigators
- Patrick L Spencer, DO, Principal investigator, Iworks Laser & Vision Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372315
- Sponsor's protocol ID
- SPENCER-2022-401
- Acronym
- DEXTENZA
- Status last verified
- Jul 2023
- First submitted
- 6 May 2022
- Last updated
- 23 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Greenwood MD, Gorham RA, Boever KR. A Randomized Fellow-Eye Clinical Trial to Evaluate Patient Preference for Dexamethasone Intracanalicular Insert or Topical Prednisolone Acetate for Control of Postoperative Symptoms Following Bilateral Femtosecond Laser in Site Keratomileusis (LASIK). Clin Ophthalmol. 2020 Aug 6;14:2223-2228. doi: 10.2147/OPTH.S265311. eCollection 2020.
PubMed 32821083
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment With an Intracanalicular Dexamethasone (0.4mg) Ophthalmic Insert in the Operating Room Following Cataract Surgery/Intraocular Lens Implant (IOL).
- ClinicalTrials.gov ID
- NCT05372315
- Acronym / sponsor ID
- DEXTENZA / SPENCER-2022-401
- Conditions
- Cataract
- Keywords
- PCIOL, CCI CE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Iworks Laser and Vision CenterUniversity, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Posted 23 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.
Detailed description
This is a randomized, controlled study to evaluate the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each subject's participation is expected to last for approximately 1 month and will be required to complete six scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 8, Day 14 and Day 30.
| Arm | Type | Receives |
|---|---|---|
| Lower Punctum Insertion (Group 1) | Other | Drug: Dextenza 0.4Mg Ophthalmic InsertDEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use Group 1 (up to 40 eyes) will receive the insert in the lower punctum on the day of surgery in the OR. |
| Upper Punctum Insertion (Group 2) | Other | Drug: Dextenza 0.4Mg Ophthalmic InsertDEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use Group 2 (up to 40 eyes) will receive the insert in the upper punctum on the of surgery in the OR. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes with or without iStent/Hydrus/Goniotomy.
- Are willing and able to comply with clinic visits and study related procedures.
- Are willing and able to sign the informed consent form.
- Not pregnant.
Key exclusion criteria (15 listed)
- Are currently being treated with corticosteroid implant (i.e. Ozurdex).
- Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye.
- Have a history of complete punctal occlusion in one or both punctum.
- Currently use topical ophthalmic steroid medications.
- Are unwilling or unable to comply with the study protocol.
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 Ophthalmic Insert(dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery. | Drug | Lower Punctum Insertion (Group 1), Upper Punctum Insertion (Group 2) |
Primary outcome
Participants With Complete Absence of Ocular Pain at Day 8
Time frame: at Day 8
Participant reported ocular pain on a scale of (0-10) with zero (0) equaling no pain and ten(10) equaling maximal pain on day 8.
Participants With Zero Cells on Day 14
Time frame: at Day 14
Proportion of of participants with complete absence of anterior chamber cell at Day 14 as measured by Summed Ocular Inflammation Score (0-4).
2 secondary outcomes
Ease of Insertion
Time frame: Day 0
Attempts to Achieve Successful Insertion
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32821083Greenwood MD, Gorham RA, Boever KR. A Randomized Fellow-Eye Clinical Trial to Evaluate Patient Preference for Dexamethasone Intracanalicular Insert or Topical Prednisolone Acetate for Control of Postoperative Symptoms Following Bilateral Femtosecond Laser in Site Keratomileusis (LASIK). Clin Ophthalmol. 2020 Aug 6;14:2223-2228. doi: 10.2147/OPTH.S265311. eCollection 2020.
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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.
Patrick L Spencer, DO principal investigator
Iworks Laser & Vision Center
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 Ophthalmic Insert in people with Cataract, run by Iworks Laser and Vision Center 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 5 inclusion and 15 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 23 Aug 2023. 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?
Yes. Results are posted in the registry (first posted 23 Aug 2023). 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?
Participants With Complete Absence of Ocular Pain at Day 8 (time frame: at 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?
On the ClinicalTrials.gov record for NCT05372315, which also lists 1 linked publication.
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 23 Aug 2023.