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

NCT04396990 | Completed Phase 4 Results FDA Drug

• 1 other identifier: The RESTORE Study
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Refractive Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Percentage of Eyes Epithelialized at Day 3

  Post-Operative Day 3

• Percentage of Eyes Fully Epithelialized at Day 4 Postoperative

  Postoperative Day 4

• Mean Pain Score Per Eye (Group A: Dextenza vs. Group B: Topical Steroid)

  Day 3

• SPEED Questionnaire Results at Baseline and Postoperative Day 28

  Pre-op Visit and Month 1 (Day 28)

• Uncorrected Distance Visual Acuity

  Month 1 and Month 3.

Study Arms (2)

Group A Dextenza

EXPERIMENTAL

Will receive Dextenza post-operative

Drug: Dextenza 0.4Mg Ophthalmic Insert

Group B Topical Prednisolone

ACTIVE COMPARATOR

Will receive standard of care prednisolone acetate 1% QID for 1 week, BID for 1 week

Drug: Topical Prednisolone

Interventions

Dextenza 0.4Mg Ophthalmic Insert DRUG

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 A Dextenza

Topical Prednisolone DRUG

Standard of care topical drop treatment

Group B Topical Prednisolone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vance Thompson Vision: lead
• Ocular Therapeutix, Inc.: collaborator

Study Sites (1)

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

MeSH Terms

Interventions

Calcium Dobesilate; Prednisolone

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Keeley Boever
• Organization: Vance Thompson Vision

keeley.boever@vancethompsonvision.com

6053613937

Study Officials

• John Berdahl, MD

  Vance Thompson Vision

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 21, 2020
• Study Start: June 8, 2020
• Primary Completion: September 28, 2020
• Study Completion: September 28, 2020
• Last Updated: July 30, 2024
• Results First Posted: August 1, 2023

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)