PREFERENTIAL Study

NCT04563559 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: Pro00104649
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cataract Surgery; Glaucoma Surgery

Outcome Measures

Primary Outcomes (2)

• 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.

  45 days post second surgery

• 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.

  45 days post second surgery

Secondary Outcomes (9)

• The incidence of AE

  Up to 3 months

• The severity of AE

  Up to 3 months

• Resolution of inflammation

  Day 14 post surgery

• Resolution of pain

  Day 7 post surgery

• Absence of cell flare at day 14

  Day 14 post surgery

Study Arms (1)

DEXTENZA vs prednisolone acetate 1%)

OTHER

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; Drug: Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]

Interventions

Dextenza 0.4Mg Ophthalmic Insert DRUG

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

DEXTENZA vs prednisolone acetate 1%)

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

DEXTENZA vs prednisolone acetate 1%)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Ocular Therapeutix, Inc.: collaborator

MeSH Terms

Interventions

Calcium Dobesilate; prednisolone acetate

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Leon Herndon, MD

  Duke Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 24, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share