The RESTORE Study, A Randomized, Controlled, Masked (Reading Center) Prospective Study

A Randomized, Controlled, Masked (Reading Center) Prospective Study of the Effectiveness and Safety of the Ocular Therapeutix Dextenza (Dexamethasone Ophthalmic Insert) 0.4 mg for the Treatment of Post-operative Inflammation and Pain in Patients Who Have Undergone PhotoREfractive Keratectomy (PRK)

To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral PRK surgery.

Study Overview

• Status: Completed
• Conditions: Refractive Surgery
• Intervention / Treatment: Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Topical Prednisolone

Detailed Description

Prospective Open-label Interventional Study Randomized, self-controlled design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, BID 1 week following bilateral PRK surgery. All eyes will receive topical moxifloxacin QID for one week. Moxifloxacin in used post-op regardless of the research. Post-operative evaluations to be performed on Day 3 and Day 4, Month 1, and Month 3. Phone call survey to be performed on Week 2.

• Study Type: Observational
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kristin Dunne; Phone Number: 605-361-3937; Email: kristin.dunne@vancethompsonvision.com

Study Locations

• United States
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Vance Thompson Vision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

All patients enrolled had elected to undergo same-day bilateral PRK procedure at a single-site.

Description

Inclusion Criteria:

• Any adult patient who is planned to undergo bilateral PRK 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.
• Patients who are pregnant (must be ruled out in women of child-bearing age with pregnancy test).
• Active infectious ocular or systemic disease.
• Patients with active infectious ocular or extraocular disease.
• Patients actively treated with local or systemic immunosuppression including systemic corticosteroids.
• Patients with known hypersensitivity to Dexamethasone.
• Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator.
• Patients with a history of ocular inflammation or macular edema.
• Patients with allergy or inability to receive intracameral antibiotic.
• Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day
• Patients with a corticosteroid implant (i.e. Ozurdex).
• Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes.
• Patients who do not have 20/20 snellen visual acuity potential pre-operatively.
• MRSE greater than 6 diopters.
• Greater than 2 diopters anisometropia.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A Dextenza; Will receive Dextenza post-operative	Drug: Dextenza 0.4Mg Ophthalmic Insert; The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.
Group B Topical Prednisolone; Will receive standard of care prednisolone acetate 1% QID for 1 week, BID for 1 week	Drug: Topical Prednisolone; Standard of care topical drop treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Preference	Primary outcome of patient reference of dexamethasone insert versus topical steroid as measured by adapted Comparison of Ophthalmic Medications for Tolerability (COMToL) questionnaire.	Through Month 1 (Day 28 +/- 3 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Eyes Epithelialized at Day 3	The percentage of eyes with fully healed epithelium at post-op day 3	Post-Operative Day 3
Percentage of Eyes Fully Epithelialized at Day 4 Postoperative	The percentage of eyes with fully healed epithelium at day 4 post-operative	Postoperative Day 4
Mean Pain Score Per Eye (Group A: Dextenza vs. Group B: Topical Steroid)	Pain score as measured by the Numerical Rating Scale (NRS) at day 3 post-operative. The rating scale is from 0-10 with 0 being no pain and 10 being severe pain.	Day 3
SPEED Questionnaire Results at Baseline and Postoperative Day 28	Patient evaluation of eye dryness measured by a modified SPEED questionnaire with a results recorded 0-28 with 28 being the most severe.	Pre-op Visit and Month 1 (Day 28)
Uncorrected Distance Visual Acuity	measured using the ETDRS acuity chart at 4 meters recorded in logMAR.	Month 1 and Month 3.
Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative	Best-corrected distance visual acuity measured using ETDRS acuity chart at 4 meters, recorded in logMAR notation	Month 1 and Month 3

Collaborators and Investigators

• Sponsor: Vance Thompson Vision
• Collaborators: Ocular Therapeutix, Inc.
• Investigators: Principal Investigator: John Berdahl, MD, Vance Thompson Vision

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2020
• Primary Completion (Actual): September 28, 2020
• Study Completion (Actual): September 28, 2020

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisolone
• Other Study ID Numbers: The RESTORE Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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