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

NCT ID: NCT04396990

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-08
• Study Completion Date: 2020-09-28

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.

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.

Conditions

Refractive Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A Dextenza

Will receive Dextenza post-operative

Group Type: EXPERIMENTAL

Dextenza 0.4Mg Ophthalmic Insert

Intervention Type: 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 B Topical Prednisolone

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

Group Type: ACTIVE_COMPARATOR

Topical Prednisolone

Intervention Type: DRUG

Standard of care topical drop treatment

Interventions

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.

Intervention Type: DRUG

Topical Prednisolone

Standard of care topical drop treatment

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ocular Therapeutix, Inc.

INDUSTRY

Sponsor Role: collaborator

Vance Thompson Vision

OTHER

Sponsor Role: lead

Responsible Party

Tiffany Facile

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Berdahl, MD

Role: PRINCIPAL_INVESTIGATOR

Vance Thompson Vision

Locations

Vance Thompson Vision

Sioux Falls, South Dakota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

The RESTORE Study

Identifier Type: -

Identifier Source: org_study_id