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Cataract SurgeryPhase 2/3NCT04563559

PREFERENTIAL Study

A Phase 2/3 study testing Dextenza 0.4Mg Ophthalmic Insert and Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE] in people with Cataract Surgery and Glaucoma Surgery, run by Duke University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by - Modified COMTOL survey. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cataract Surgery, Glaucoma Surgery
What is being tested?
Dextenza 0.4Mg Ophthalmic Insert and Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Nov 2020to Nov 2021
Phase
Phase 2/3
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years and older
  • Presence of a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens (IOL), and potential postoperative Snellen pinhole CDVA of at least 20/200 in both eyes
  • 10 patients with mild-to-moderate primary open angle glaucoma and a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber IOL combined with a Minimally Invasive Glaucoma Surgery (MIGS) procedure in both eyes

Who cannot join

  • 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
  • Laser or incisional ocular surgery during the study period and 6 months prior in either eye
  • Systemic concomitant pain medication management with pharmacologic class of oxycodone
Show all 10Show fewer
  • Systemic NSAID use
  • o Pre-procedural wash-out period for topical NSAIDS, ocular steroid, cyclosporine of 7 days
  • Clinically significant macular edema (CSME)
  • History of cystoid macular edema in the study eye

About this study

Official title: Patient PReference, Efficacy, and SaFety of an Intracanalicular DExamenthasone InseRt comparEd to Topical PrednisoloNe in PatienTs UndergoIng SequentiAl PhacoemuLsification With Intraocular Lens Surgery OR Combined Phacoemulsification With IOL and a Minimally Invasive Glaucoma Surgery (MIGS)

To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by - Modified COMTOL survey.

Read the detailed description

Eyes from 80 patients will be randomized in a 1:1 ratio to the assigned treatment, dexamethasone insert placed at the time of surgery, or topical prednisolone acetate 1% therapy prescribed on a tapering dose schedule post-operatively.

Males and Females 18 years and older with 1)Presence of a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens (IOL), and potential postoperative Snellen pinhole corrected distance visual acuity (CDVA) of at least 20/200 in both eyes and 2) 10 patients with mild-to-moderate primary open angle glaucoma and a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber Intraocular Len (IOL) combined with a Minimally Invasive Glaucoma Surgery (MIGS) procedure in both eyes.

Study visits will consist of eye exam with ocular photos from an Optical Coherence Tomography (OCT).

Being tested
Dextenza 0.4Mg Ophthalmic Insert, Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dextenza 0.4Mg Ophthalmic InsertDrug

    The eye will have a sustained release device of Dexamethasone 0.4 mg placed in the inferior nasal lacrimal system.

  • Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]Drug

    The eye will be randomized to receive topical treatment with prednisolone acetate 1% on a tapering dose schedule

Study groups in NCT04563559
Study groupRoleWhat they receive
DEXTENZA vs prednisolone acetate 1%)OtherSubjects will randomly receive Dextenza or prednisolone acetate 1% in the first eye after surgery. At the time of the second eye surgery, the other eye will receive the drug that the first eye did not receive. Subjects will receive both drugs during the course of the study and therefore there is only 1 ARM for this study.
Receives: Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent of patients who stated they preferred dexamethasone insert as measured by patient report

    To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by Modified COMTOL survey.

    Measured: 45 days post second surgery

  2. Percent of patients who stated they preferred topical prednisolone insert as measured by patient report

    To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by Modified COMTOL survey.

    Measured: 45 days post second surgery

Secondary outcomes (9)

  1. The incidence of AE

    The incidence of adverse events

    Measured: Up to 3 months

  2. The severity of AE

    The severity of adverse events

    Measured: Up to 3 months

  3. Resolution of inflammation

    Resolution of inflammation as defined as either 0 or 0.5 cells or less cells on post-surgical day 14 as measured by SUN scale in an unmasked fashion.

    Measured: Day 14 post surgery

  4. Resolution of pain

    Resolution of pain as defined by a score of 0 measured by pain scale on post-surgical day 7

    Measured: Day 7 post surgery

  5. Absence of cell flare at day 14

    Absence of cell flare at day 14

    Measured: Day 14 post surgery

  6. Mean change in BCVA

    Mean change in BCVA

    Measured: Baseline, 3 months

  7. Mean change in central retinal thickness as measured by OCT

    Mean change in central retinal thickness as measured by OCT

    Measured: Baseline, 3 months

  8. Percent of patients who maintained normalized central retinal thickness at 28 days post surgery

    Percent of patients who maintained normalized central retinal thickness at 28 days post surgery

    Measured: 28 days post surgery

  9. Percent of patients with rebound inflammation

    Percent of patients with rebound inflammation

    Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2020
  2. Study startNov 2020 (estimated)
  3. Primary completionNov 2021 (estimated)
  4. Study completionNov 2021 (estimated)

Why it stopped: PI decided not to open study

Resources

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 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04563559
Sponsor's protocol ID
Pro00104649
Status last verified
Nov 2021
First submitted
21 Sep 2020
Last updated
17 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Dextenza 0.4Mg Ophthalmic Insert and Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE] in people with Cataract Surgery and Glaucoma Surgery, run by Duke University.

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 3 inclusion and 10 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: withdrawn, as of the sponsor's last update on 17 Nov 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Percent of patients who stated they preferred dexamethasone insert as measured by patient report (time frame: 45 days post second surgery). 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 NCT04563559.

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 17 Nov 2021.

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PREFERENTIAL Study (NCT04563559) | AzTrials