CataractPhase 4NCT05665270
A Study for Post op Inflammation After Cataract Surgery
A Phase 4 study testing Dextenza 0.4Mg Ophthalmic Insert and Prednisolone Acetate 1% in people with Cataract, run by Wyse Eyecare at 1 site in United States.
Trial summary
This is a randomized, controlled study to assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert when utilized in conjunction with topical steroids as part of an extended taper steroid regimen following cataract surgery in patients with a history of epiretinal membrane… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Dextenza 0.4Mg Ophthalmic Insert and Prednisolone Acetate 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2023to 15 Dec 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 18 years and older
- 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 and have a history of epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration.
- Are willing and able to comply with clinic visits and study related procedures
- Are willing and able to sign the informed consent form
- Patients age 18yo+
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 an obstructed nasolacrimal duct in the study eye(s) (dacryocystitis)
- Have known hypersensitivity to dexamethasone or are a known steroid responder
- Have a history of ocular inflammation or macular edema
Show all 15Show fewer
- 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 currently pregnant or nursing.
- 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
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment
This is a randomized, controlled study to assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert when utilized in conjunction with topical steroids as part of an extended taper steroid regimen following cataract surgery in patients with a history of epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration.
Read the detailed description
There will be approximately 40 eyes with two groups:
Group 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8).
Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week.
Both groups will receive topical Prolensa Qa.m. x 5 weeks and Moxifloxacin TID x 1 week, per investigators preferential treatment regimen.
Each subject's participation is expected to last for approximately 5 weeks and subjects will be required to complete six scheduled visits over the course of the study period: Baseline (Screening Visit Day -1), Operative Visit (Day 0), Day 1, Day 8 (insertion day), Day 14, and Day 37.
- Conditions
- Cataract
- Being tested
- Dextenza 0.4Mg Ophthalmic Insert, Prednisolone Acetate 1%
- 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
Group 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8). Both groups will receive topical Prolensa Qa.m. x 5 weeks and Moxifloxacin TID x 1 week, per investigators preferential treatment regimen.
Prednisolone Acetate 1%Drug
Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week.
Both groups will receive topical Prolensa Qa.m. x 5 weeks and Moxifloxacin TID x 1 week, per investigators preferential treatment regimen.
| Study group | Role | What they receive |
|---|---|---|
| Dextenza | Experimental | Group 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8). Receives: Drug: Dextenza 0.4Mg Ophthalmic Insert |
| Prednisolone Acetate | Active comparator | Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week. Receives: Drug: Prednisolone Acetate 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of anterior chamber cells
SUN Scale (0 minimum/better to 4 maximum/ worse)
Measured: at Day 14
Secondary outcomes (12)
BCVA
Snellen Chart
Measured: Baseline (day 8) to day 37
Number of subjects requiring rescue steroid
Addition of steroid treatment
Measured: Day 8 to Day 37
Number and Percentage of subjects with complete absence of cell
SUN Scale
Measured: Day 8 to 37
Measuring Cell
Sun Scale (0 minimum/better to 4 maximum/ worse)
Measured: Day 8, 14, 37
Measuring Flare
Sun Scale (0 minimum/better to 4 maximum/ worse)
Measured: Day 8, 14, 37
Eye Pain
VAS Questionnaire 0 no pain to 10 worst possible pain
Measured: Day 8, 14, 37
Ease of insertion
Noted as Easy, Moderate, or Difficult
Measured: Day 8
Ease of Visualization
Noted as Easy, Moderate, or Difficult
Measured: Day 8, 14, 37
Number of attempts to successfully insertion
Note Number of attempts to successfully insert as 1,2,3 attempts
Measured: Day 8
Dry Eye
SPEED Survey Lower score indicates less dryness which is better than a higher score
Measured: Day 8, Day 14, and Day 37.
Central Macular Thickness
Mean change of Central Macular Thickness by Optical coherence tomography
Measured: Baseline to Day 37
Insert Retention
By slit lamp exam if insert is visualized or not
Measured: Day 8 to 37 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start30 Jan 2023
- Primary completion31 Oct 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
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
- Model description
- This is a randomized, controlled study to assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert when utilized in conjunction with topical steroids as part of an extended taper steroid regimen following cataract surgery in patients with a history of epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration Group 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8). Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wyse Eyecare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665270
- Sponsor's protocol ID
- WCG IRB Protocol #20225859
- Status last verified
- Apr 2023
- First submitted
- 10 Nov 2022
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- 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 26 Apr 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
- ClinicalTrials.gov ID
- NCT05665270
- Acronym / sponsor ID
- WCG IRB Protocol #20225859
- Conditions
- Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wyse EyecareUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 27 Dec 2022 (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.
This is a randomized, controlled study to assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert when utilized in conjunction with topical steroids as part of an extended taper steroid regimen following cataract surgery in patients with a history of epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration.
Detailed description
There will be approximately 40 eyes with two groups:
Group 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8).
Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week.
Both groups will receive topical Prolensa Qa.m. x 5 weeks and Moxifloxacin TID x 1 week, per investigators preferential treatment regimen.
Each subject's participation is expected to last for approximately 5 weeks and subjects will be required to complete six scheduled visits over the course of the study period: Baseline (Screening Visit Day -1), Operative Visit (Day 0), Day 1, Day 8 (insertion day), Day 14, and Day 37.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, controlled study to assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert when utilized in conjunction with topical steroids as part of an extended taper steroid regimen following cataract surgery in patients with a history of epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration Group 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8). Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week.
| Arm | Type | Receives |
|---|---|---|
| Dextenza | Experimental | Drug: Dextenza 0.4Mg Ophthalmic InsertGroup 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8). |
| Prednisolone Acetate | Active comparator | Drug: Prednisolone Acetate 1%Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week. |
Who may qualify
- Ages
- 18 years and older
- 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 and have a history of epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration.
- Are willing and able to comply with clinic visits and study related procedures
- Are willing and able to sign the informed consent form
- Patients age 18yo+
Key exclusion criteria (15 listed)
- Have active infectious systemic disease
- Have active infectious ocular or extraocular disease
- Have an obstructed nasolacrimal duct in the study eye(s) (dacryocystitis)
- Have known hypersensitivity to dexamethasone or are a known steroid responder
- Have a history of ocular inflammation or macular edema
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 InsertGroup 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8). Both groups will receive topical Prolensa Qa.m. x 5 weeks and Moxifloxacin TID x 1 week, per investigators preferential treatment regimen. | Drug | Dextenza |
| Prednisolone Acetate 1%Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week. Both groups will receive topical Prolensa Qa.m. x 5 weeks and Moxifloxacin TID x 1 week, per investigators preferential treatment regimen. | Drug | Prednisolone Acetate |
Primary outcome
Absence of anterior chamber cells
Time frame: at Day 14
SUN Scale (0 minimum/better to 4 maximum/ worse)
12 secondary outcomes
BCVA
Time frame: Baseline (day 8) to day 37
Number of subjects requiring rescue steroid
Time frame: Day 8 to Day 37
Number and Percentage of subjects with complete absence of cell
Time frame: Day 8 to 37
Measuring Cell
Time frame: Day 8, 14, 37
Measuring Flare
Time frame: Day 8, 14, 37
Eye Pain
Time frame: Day 8, 14, 37
Ease of insertion
Time frame: Day 8
Ease of Visualization
Time frame: Day 8, 14, 37
Number of attempts to successfully insertion
Time frame: Day 8
Dry Eye
Time frame: Day 8, Day 14, and Day 37.
Central Macular Thickness
Time frame: Baseline to Day 37
Insert Retention
Time frame: Day 8 to 37 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 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.
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 4 study testing Dextenza 0.4Mg Ophthalmic Insert and Prednisolone Acetate 1% in people with Cataract, run by Wyse Eyecare 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: status not confirmed, as of the sponsor's last update on 26 Apr 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?
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?
Absence of anterior chamber cells (time frame: at Day 14). 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 26 Apr 2023.