Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-02-05

Brief Summary

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Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

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Detailed Description

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Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt Treating Pain, and inflamMation Following Cataract Surgery Compared to Topical Prednisolone Acetate 1%.

Conditions

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Corneal Edema Corneal Defect Anterior Chamber Inflammation Ocular Pain Corneal Staining Visual Outcome CME - Cystoid Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In patient who undergo cataract surgery, subjects will be randomized to 2 arms and be followed for a period of 3 months.

Arm 1- control group, 25 subjects will receive Prednisolone Acetate 1% QID x 2 weeks then BID x 2 weeks.

Arm 2 - study group, 25 subjects will receive Dextenza 0.4mg insert

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1 - Cataract surgery gtt regimen per SOC

Following cataract surgery (without Dextenza 0.4mg insert) patients will receive: Prednisolone Acetate 1% QID X 2 Weeks, then BID x 2 weeks and stop / Prolensa 0.07% QD X 4 Weeks and stop.

Group Type ACTIVE_COMPARATOR

Prednisolone Acetate 1% Oph Susp

Intervention Type DRUG

Prednisolone Acetate 1% is a corticosteroid (to decrease inflammation) and being used as a topical drop after cataract surgery per Standard Of Care.

Prolensa 0.07% Ophthalmic Solution

Intervention Type DRUG

Prolensa 0.07% is a NSAID (to decrease inflammation, swelling and pain) and is being used as a topical drop after cataract surgery per Standard Of Care.

Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimen

Following cataract surgery with DEXTENZA 0.4mg insert, patients will receive: Prolensa 0.07% QD X 4 Weeks and stop

Group Type EXPERIMENTAL

Dextenza 0.4Mg Ophthalmic Insert

Intervention Type DRUG

DEXTENZA 0.4Mg Ophthalmic Insert is a corticosteroid (to decrease inflammation) intracanalicular insert placed in the punctum, a natural opening in the eye lid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives.

Prolensa 0.07% Ophthalmic Solution

Intervention Type DRUG

Prolensa 0.07% is a NSAID (to decrease inflammation, swelling and pain) and is being used as a topical drop after cataract surgery per Standard Of Care.

Interventions

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Dextenza 0.4Mg Ophthalmic Insert

DEXTENZA 0.4Mg Ophthalmic Insert is a corticosteroid (to decrease inflammation) intracanalicular insert placed in the punctum, a natural opening in the eye lid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives.

Intervention Type DRUG

Prednisolone Acetate 1% Oph Susp

Prednisolone Acetate 1% is a corticosteroid (to decrease inflammation) and being used as a topical drop after cataract surgery per Standard Of Care.

Intervention Type DRUG

Prolensa 0.07% Ophthalmic Solution

Prolensa 0.07% is a NSAID (to decrease inflammation, swelling and pain) and is being used as a topical drop after cataract surgery per Standard Of Care.

Intervention Type DRUG

Other Intervention Names

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Dexamethasone 0.4mg

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with clinically significant cataract and are planning to undergo non-complicated Clear Cornea Incision Cataract Extraction with Posterior Capsule IntraOcular Lens 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

Exclusion Criteria

* Under the age of 18 at the time of signing the Informed Consent Form
* Pregnant or planning to become pregnant during the trial period
* Have visual acuity potential of less than 20/30 as recorded by a Retinal Acuity Meter or Potential Acuity Meter glare testing
* Have active infectious systemic disease
* Have active infectious ocular or extraocular disease
* Have punctal plug in the study eye
* Have obstructed nasolacrimal duct in the study eye(s) (dacryocystitus)
* Have known hypersensitivity to dexamethasone or are a known steroid responder
* Have a history of ocular inflammation or macular edema
* Has history of Laser Vision Correction (LASIK, PhotoRefractive Keratectomy) in the operated eye
* Are currently being treated with immunomodulating agents in the study eye
* 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 using 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) if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No