CataractPhase 4NCT05143281
The SITE Study - Dexamethasone Ophthalmic Insert In OR on Day of Surgery Versus In-office Post-Op Day 1
A Phase 4 study testing Dexamethasone 0.4 MG [Dextenza] in people with Cataract, run by Grene Vision Group at 2 sites 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) compared to insertion 1-day post-op. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Dexamethasone 0.4 MG [Dextenza]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Dec 2021to 1 Feb 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects will be eligible for study participation if they:
- Are an adult subject aged 65 years or older Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes Are willing and able to comply with clinic visits and study related procedures Are willing and able to sign the informed consent form
Who cannot join
- Subjects are not eligible for study participation if they:
- Have active infectious systemic disease Have active infectious ocular or extraocular disease Have unobstructed nasolacrimal duct in the study eye(s) 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 and/or oral steroids 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 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Grene Vision Group
Wichita, Kansas, 67208
Grene Vision Group
Wichita, Kansas, 67212
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) Compared to Insertion 1-day Post-op - The SITE Study
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) compared to insertion 1-day post-op.
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) compared to insertion 1-day post-op.
There will be approximately 50 eyes with two groups:
Group 1 (up to 10 eyes) will receive the insert in the lower punctum on the day of surgery in the OR.
Group 2 (up to 40 eyes) will receive the insert in the lower punctum on the day after surgery in the HOPD.
Each subject's participation is expected to last for approximately 1 month and will be required to complete five scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 7 and Day 30.
- Conditions
- Cataract
- Being tested
- Dexamethasone 0.4 MG [Dextenza]
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 0.4 MG [Dextenza]Drug
Also called Dextenza
Ophthalmic Intracanalicular Insert
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Ophthalmic Insert Day of Surgery | Experimental | Day of surgery, in OR placement Receives: Drug: Dexamethasone 0.4 MG [Dextenza] |
| Dexamethasone Ophthalmic Insert Day 1 Post Op | Experimental | Day 1 Post-Op, In-office (HOPD) Receives: Drug: Dexamethasone 0.4 MG [Dextenza] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior Chamber Cells
As measured by summed ocular inflammation score (0-4 with 4 meaning a worse outcome)
Measured: Assessed on Day 7
Ocular Pain
As measured by ocular pain assessment numerical grading scale (0-10 with 10 meaning a worse outcome)
Measured: Assessed on Day 7
Secondary outcomes (4)
Mean change in BCVA
As measured by snellen VA
Measured: Assessed on Day -1, Day 7, Day 30
Percentage with complete absence of pain
As measured by ocular pain assessment numerical grading scale (0-10 with 10 meaning a worse outcome)
Measured: Assessed on Day -1, Day 1, Day 7, Day 30
Percentage with complete absence of cell
As measured by summed ocular inflammation score (0-4 with 4 meaning a worse outcome)
Measured: Assessed on Day -1, Day 1, Day 7, Day 30
Physician ease of insertion and visualization
As measured by physician questionnaire
Measured: Assessed on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start13 Dec 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grene Vision Group
- Sponsor type
- University, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Responsible party
- Sponsor
- Investigators
- Anita Campbell, MD, Principal investigator, Grene Vision Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143281
- Sponsor's protocol ID
- SITE-2021-4001
- Status last verified
- Jul 2023
- First submitted
- 22 Nov 2021
- Last updated
- 6 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 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) Compared to Insertion 1-day Post-op - The SITE Study
- ClinicalTrials.gov ID
- NCT05143281
- Acronym / sponsor ID
- SITE-2021-4001
- Conditions
- Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Grene Vision GroupUniversity, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 3 Dec 2021 (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 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) compared to insertion 1-day post-op.
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) compared to insertion 1-day post-op.
There will be approximately 50 eyes with two groups:
Group 1 (up to 10 eyes) will receive the insert in the lower punctum on the day of surgery in the OR.
Group 2 (up to 40 eyes) will receive the insert in the lower punctum on the day after surgery in the HOPD.
Each subject's participation is expected to last for approximately 1 month and will be required to complete five scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 7 and Day 30.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Ophthalmic Insert Day of Surgery | Experimental | Drug: Dexamethasone 0.4 MG [Dextenza]Day of surgery, in OR placement |
| Dexamethasone Ophthalmic Insert Day 1 Post Op | Experimental | Drug: Dexamethasone 0.4 MG [Dextenza]Day 1 Post-Op, In-office (HOPD) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Subjects will be eligible for study participation if they:
- Are an adult subject aged 65 years or older Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes Are willing and able to comply with clinic visits and study related procedures Are willing and able to sign the informed consent form
Key exclusion criteria (2 listed)
- Subjects are not eligible for study participation if they:
- Have active infectious systemic disease Have active infectious ocular or extraocular disease Have unobstructed nasolacrimal duct in the study eye(s) 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 and/or oral steroids 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 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
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 0.4 MG [Dextenza]Also: DextenzaOphthalmic Intracanalicular Insert | Drug | Dexamethasone Ophthalmic Insert Day 1 Post Op, Dexamethasone Ophthalmic Insert Day of Surgery |
Primary outcome
Anterior Chamber Cells
Time frame: Assessed on Day 7
As measured by summed ocular inflammation score (0-4 with 4 meaning a worse outcome)
Ocular Pain
Time frame: Assessed on Day 7
As measured by ocular pain assessment numerical grading scale (0-10 with 10 meaning a worse outcome)
4 secondary outcomes
Mean change in BCVA
Time frame: Assessed on Day -1, Day 7, Day 30
Percentage with complete absence of pain
Time frame: Assessed on Day -1, Day 1, Day 7, Day 30
Percentage with complete absence of cell
Time frame: Assessed on Day -1, Day 1, Day 7, Day 30
Physician ease of insertion and visualization
Time frame: Assessed on Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Anita Campbell, MD principal investigator
Grene Vision Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone 0.4 MG [Dextenza] in people with Cataract, run by Grene Vision Group at 2 sites 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 2 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 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anterior Chamber Cells (time frame: Assessed on Day 7). 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 6 Jul 2023.