Assessing Dextenza Insert After SMILE Procedure

NCT04380857 | Completed Phase 4 Results FDA Drug

• 1 other identifier: WW-2020-DexSMILE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Post Procedural Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Lines Lost From Best Corrected Visual Acuity

  Baseline through Day 90

• Loss of Lines in Uncorrected Visual Acuity

  Baseline to Day 7, Day 30 and Day 90

• Post op Pain Management Per Eye

  Day 0 to Day 90

• Patient Preference Between Groups

  Day 7, Day 30 and Day 90

Study Arms (2)

Dexamethasone ophthalmic insert 0.4 mg

EXPERIMENTAL

Dexamethasone ophthalmic insert 0.4 mg

Drug: Dexamethasone ophthalmic insert 0.4 mg

Topical prednisolone acetate ophthalmic drops

ACTIVE COMPARATOR

topical prednisolone acetate ophthalmic drops

Drug: Topical Prednisolone Acetate Ophthalmic Drops

Interventions

Dexamethasone ophthalmic insert 0.4 mg DRUG

intracanalicular dexamethasone insert

Also known as: Dextenza

Dexamethasone ophthalmic insert 0.4 mg

Topical Prednisolone Acetate Ophthalmic Drops 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

Also known as: Prednisolone Acetate

Topical prednisolone acetate ophthalmic drops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• William Wiley, MD: lead

Study Sites (1)

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

MeSH Terms

Interventions

Calcium Dobesilate; prednisolone acetate

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Kathleen Jee, MD
• Organization: Cleveland Eye Clinic

kjee@midwestvision.com

440-526-1974

Study Officials

• William Wiley, MD

  Cleveland Eye Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 8, 2020
• Study Start: June 18, 2020
• Primary Completion: June 21, 2021
• Study Completion: June 21, 2021
• Last Updated: October 6, 2023
• Results First Posted: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)