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

• Sponsor: Vance Thompson Vision (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04396990
• Collaborator: Ocular Therapeutix, Inc. (Industry)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.6
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Refractive Surgery	Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Topical Prednisolone	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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)
• Actual Study Start Date: May 15, 2020
• Actual Primary Completion Date: Nov 1, 2020
• Anticipated Study Completion Date: Jan 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A Dextenza	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.
Active Comparator: Group B Topical Prednisolone	Drug: Topical Prednisolone; Standard of care topical drop treatment

Outcome Measures

Primary Outcome Measures

1. Patient preference [Through Month 1 (Day 28 +/- 3 days)]

   As measured by adapted COMTOL survey

Secondary Outcome Measures

1. Percentage of eyes epithelialized at Day 3 and Day 4. [Post-Operative Day 3 and 4:]

2. Mean pain score per eye (Group A vs. Group B) [Day 3, Day 4, Week 2 (collected via telephone survey), and Month 1]

   measured by the Numerical Rating Scale (NRS)

3. Patient preference [Pre-op Visit and Month 1.]

   measured by a modified SPEED questionnaire

4. Incidence and grade of post-operative corneal haze [Pre-op Visit, Month 1, and Month 3.]

   measured by Heidelberg Anterior Segment OCT

5. Post-operative corneal staining score [Day 3, Day 4, Month 1, and Month 3.]

   measured by the National Eye Institute (NEI) grading system

6. Uncorrected visual acuity [Month 1 and Month 3.]

   measured by ETDRS chart at 4m

7. Manifest Refraction Spherical Equivalent [1 and Month 3]

   measured by the Optometrist

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vance Thompson Vision	Sioux Falls	South Dakota	United States	57108

Sponsors and Collaborators

• Vance Thompson Vision
• Ocular Therapeutix, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John Berdahl, MD, Principal Investigator, Vance Thompson Vision
• ClinicalTrials.gov Identifier: NCT04396990
• Other Study ID Numbers: The RESTORE Study
• First Posted: May 21, 2020
• Last Update Posted: Nov 16, 2020
• Last Verified: Nov 1, 2020

• 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: Prednisolone

Study Results

No Results Posted as of Nov 16, 2020