Assessing Dextenza Insert After SMILE Procedure

• Sponsor: William Wiley, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT04380857
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.9
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Post Procedural Infection	Drug: Dexamethasone ophthalmic insert 0.4 mg	Phase 4

Detailed 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

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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 SMILEFirst 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
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: May 4, 2020
• Actual Primary Completion Date: Jun 30, 2021
• Actual Study Completion Date: Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexamethazone ophthalmic insert 0.4 mg Dexamethazone ophthalmic insert 0.4 mg	Drug: Dexamethasone ophthalmic insert 0.4 mg; intrcanalicular dexamethasone insert; Other Names: Dextenza
Experimental: topical prednisolone acetate ophthalmic drops topical prednisolone acetate ophthalmic drops	Drug: Dexamethasone ophthalmic insert 0.4 mg; intrcanalicular dexamethasone insert; Other Names: Dextenza

Outcome Measures

Primary Outcome Measures

1. Mean change in pain [Change is being assessed from Day 1 to Month 3]

   post-op pain as measure on a scale from 0-10 (ocular pain assessment)

Secondary Outcome Measures

1. Mean change in BCVA [Through week 12]

   Change in best corrected visual acuity

2. Mean change in UCVA [Through week 12]

   Change in uncorrected visual acuity

3. Post op pain management per eye [Change is being assessed Day 1, Day 7, Day 30, Month 3]

   Proportion of patient callbacks with pain reports

4. Patient preference between groups [Change is being assessed Day 1, Day 7, Day 30, Month 3]

   As measure by patient symptoms questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Eye Clinic	Brecksville	Ohio	United States	44141

Sponsors and Collaborators

• William Wiley, MD

Investigators

• Principal Investigator: William Wiley, MD, Cleveland Eye Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: William Wiley, MD, Principal Investigator, Cleveland Eye Clinic
• ClinicalTrials.gov Identifier: NCT04380857
• Other Study ID Numbers: WW-2020-DexSMILE
• First Posted: May 8, 2020
• Last Update Posted: Jul 27, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Dexamethasone

Study Results

No Results Posted as of Jul 27, 2021