Assessing Dextenza Insert After SMILE Procedure

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-18

Study Completion Date

2021-06-21

Brief Summary

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This three-month prospective, open-label, single-center, randomized investigator initiated clinical study seeks to investigate the efficacy of DEXTENZA when placed in the lower canaliculus (study eye) compared to topical corticosteroids (control eye) following bilateral SMILE surgery. In addition, the study will evaluate physician assessment of ease of DEXTENZA insertion

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Detailed Description

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4.1 Study Population The study aims to enroll 20 patients undergoing bilateral SMILE.

4.1.1 Inclusion Criteria

A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

* Age 18 years and older
* Scheduled for bilateral SMILE surgery
* Willing and able to comply with clinic visits and study related procedures
* Willing and able to sign the informed consent form

4.1.2 Exclusion Criteria

A patient who meets any of the following criteria will be excluded from the study:

* Patients under the age of 18.
* Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
* Active infectious systemic disease
* Active infectious ocular or extraocular disease
* Obstructed nasolacrimal duct in the study eye(s)
* Hypersensitivity to dexamethasone
* Patients being treated with immunomodulating agents in the study eye(s)
* Patients being treated with immunosuppressants and/or oral steroids Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Conditions

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Post Procedural Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

First eye randomized for either topical prednisolone acetate (control eye) or lower eyelid canaliculus Dextenza insertion (study eye) and the contralateral eye receiving opposite treatment in the OR following SMILE

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dexamethasone ophthalmic insert 0.4 mg

Group Type EXPERIMENTAL

Dexamethasone ophthalmic insert 0.4 mg

Intervention Type DRUG

intracanalicular dexamethasone insert

Topical prednisolone acetate ophthalmic drops

topical prednisolone acetate ophthalmic drops

Group Type ACTIVE_COMPARATOR

Topical Prednisolone Acetate Ophthalmic Drops

Intervention Type DRUG

Topical Prednisolone acetate ophthalmic drops per standard of care:

Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue

Interventions

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Dexamethasone ophthalmic insert 0.4 mg

intracanalicular dexamethasone insert

Intervention Type DRUG

Topical Prednisolone Acetate Ophthalmic Drops

Topical Prednisolone acetate ophthalmic drops per standard of care:

Every two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue

Intervention Type DRUG

Other Intervention Names

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Dextenza Prednisolone Acetate

Eligibility Criteria

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Inclusion Criteria

* Age 18 years and older
* Scheduled for bilateral SMILE surgery
* Willing and able to comply with clinic visits and study related procedures
* Willing and able to sign the informed consent form

Exclusion Criteria

* Patients under the age of 18.
* Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
* Active infectious systemic disease
* Active infectious ocular or extraocular disease
* Obstructed nasolacrimal duct in the study eye(s)
* Hypersensitivity to dexamethasone
* Patients being treated with immunomodulating agents in the study eye(s)
* Patients being treated with immunosuppressants and/or oral steroids Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No