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ClinicalTrials.gov Identifier: NCT04563559
Recruitment Status : Withdrawn (PI decided not to open study)
First Posted : September 24, 2020
Last Update Posted : November 17, 2021
Sponsor:
Collaborator:
Ocular Therapeutix, Inc.
Information provided by (Responsible Party):
Duke University

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

Condition or disease Intervention/treatment Phase
Cataract Surgery Glaucoma Surgery Drug: Dextenza 0.4Mg Ophthalmic Insert Drug: Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE] Phase 2 Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021


Arm Intervention/treatment
DEXTENZA vs prednisolone acetate 1%)
Subjects 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.
Drug: Dextenza 0.4Mg Ophthalmic Insert
The eye will have a sustained release device of Dexamethasone 0.4 mg placed in the inferior nasal lacrimal system.

Drug: Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]
The eye will be randomized to receive topical treatment with prednisolone acetate 1% on a tapering dose schedule




Primary Outcome Measures :
  1. Percent of patients who stated they preferred dexamethasone insert as measured by patient report [ Time Frame: 45 days post second surgery ]
    To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by Modified COMTOL survey.

  2. Percent of patients who stated they preferred topical prednisolone insert as measured by patient report [ Time Frame: 45 days post second surgery ]
    To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by Modified COMTOL survey.


Secondary Outcome Measures :
  1. The incidence of AE [ Time Frame: Up to 3 months ]
    The incidence of adverse events

  2. The severity of AE [ Time Frame: Up to 3 months ]
    The severity of adverse events

  3. Resolution of inflammation [ Time Frame: Day 14 post surgery ]
    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.

  4. Resolution of pain [ Time Frame: Day 7 post surgery ]
    Resolution of pain as defined by a score of 0 measured by pain scale on post-surgical day 7

  5. Absence of cell flare at day 14 [ Time Frame: Day 14 post surgery ]
    Absence of cell flare at day 14

  6. Mean change in BCVA [ Time Frame: Baseline, 3 months ]
    Mean change in BCVA

  7. Mean change in central retinal thickness as measured by OCT [ Time Frame: Baseline, 3 months ]
    Mean change in central retinal thickness as measured by OCT

  8. Percent of patients who maintained normalized central retinal thickness at 28 days post surgery [ Time Frame: 28 days post surgery ]
    Percent of patients who maintained normalized central retinal thickness at 28 days post surgery

  9. Percent of patients with rebound inflammation [ Time Frame: Up to 3 months ]
    Percent of patients with rebound inflammation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04563559


Sponsors and Collaborators
Duke University
Ocular Therapeutix, Inc.
Investigators
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Principal Investigator: Leon Herndon, MD Duke Eye Center
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04563559    
Other Study ID Numbers: Pro00104649
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: November 17, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Glaucoma
Cataract
Ocular Hypertension
Eye Diseases
Lens Diseases
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents