Assessing Dextenza Insert After SMILE Procedure

Post Procedural Infection Clinical Trial

Official title:

Assessing the Efficacy of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Comparison to Topical Prednisolone Acetate Following Bilateral Small Incision Lenticule Extraction (SMILE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04380857
• Other study ID #: WW-2020-DexSMILE
• Status: Completed
• Phase: Phase 4
• Start date: June 18, 2020
• Est. completion date: June 21, 2021

Study information

• Verified date: September 2023
• Source: Cleveland Eye Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 21, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post Procedural Infection

Intervention

Drug:
• Dexamethasone ophthalmic insert 0.4 mg
intracanalicular dexamethasone insert
• 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

Locations

Country	Name	City	State
United States	Cleveland Eye Clinic	Brecksville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
William Wiley, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Pain	post-op pain as measured as scores on an Ocular Pain Assessment Scale from 0-10 ("0" being no pain and "10" being the worst pain you could imagine)	Change is being assessed at Baseline, Day 1, Day 7, Day 30 and Day 90
Secondary	Number of Lines Lost From Best Corrected Visual Acuity	After manifest refraction all units assessed for best corrected distance visual acuity using ETDRS. Number of lines seen was then converted to LogMar score (on a scale of -0.30 to 1.00 where smaller numbers indicate better vision and larger numbers indicate worse vision) to measure changes in Best Corrected Distance Visual Acuity between Baseline and Day 90	Baseline through Day 90
Secondary	Loss of Lines in Uncorrected Visual Acuity	All units assessed for uncorrected visual acuity using ETDRS. Number of lines seen was then converted to LogMar to measure changes in uncorrected visual acuity between Baseline and Day 90.	Baseline to Day 7, Day 30 and Day 90
Secondary	Post op Pain Management Per Eye	Count of participants requiring pain management from Day 0 to Day 90.	Day 0 to Day 90
Secondary	Patient Preference Between Groups	As reported by patients choosing one of five options; Strongly preferred insert, preferred insert, no preference, preferred standard drop regimen, strongly preferred standard drop regimen.	Day 7, Day 30 and Day 90