Assessing Dextenza Insert After SMILE Procedure

William Wiley, MD

Status and phase: Completed; Phase 4

Conditions: Post Procedural Infection

Treatments: Drug: Dexamethasone ophthalmic insert 0.4 mg; Drug: Topical Prednisolone Acetate Ophthalmic Drops

Study type: Interventional

Funder types: Other

Identifiers

NCT04380857

WW-2020-DexSMILE

Details and patient eligibility

About

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

Full description

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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Dexamethasone ophthalmic insert 0.4 mg

Experimental group

Description:

Dexamethasone ophthalmic insert 0.4 mg

Treatment:

Drug: Dexamethasone ophthalmic insert 0.4 mg

Topical prednisolone acetate ophthalmic drops

Active Comparator group

Description:

topical prednisolone acetate ophthalmic drops

Treatment:

Drug: Topical Prednisolone Acetate Ophthalmic Drops