Clinical trial NCT04396990: The RESTORE Study, A Randomized, Controlled, Masked (Reading Center) Prospective Study
Official title: A Randomized, Controlled, Masked (Reading Center) Prospective Study of the Effectiveness and Safety of the Ocular Therapeutix Dextenza 0.4 mg for the Treatment of Post-op. Inflammation and Pain in PRK
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Refractive Surgery
Lead sponsor: Vance Thompson Vision
Sponsor class: OTHER
Collaborators: name: Ocular Therapeutix, Inc.
First posted: 2020-05-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Patient Preference
timeFrame: Through Month 1 (Day 28 +/- 3 days)
Secondary outcomes:
measure: Percentage of Eyes Epithelialized at Day 3
timeFrame: Post-Operative Day 3
measure: Percentage of Eyes Fully Epithelialized at Day 4 Postoperative
timeFrame: Postoperative Day 4
measure: Mean Pain Score Per Eye (Group A: Dextenza vs. Group B: Topical Steroid)
timeFrame: Day 3
measure: SPEED Questionnaire Results at Baseline and Postoperative Day 28
timeFrame: Pre-op Visit and Month 1 (Day 28)
measure: Uncorrected Distance Visual Acuity
timeFrame: Month 1 and Month 3.
measure: Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative
timeFrame: Month 1 and Month 3
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
Study officials:
affiliation: Vance Thompson Vision
name: John Berdahl, MD
role: PRINCIPAL_INVESTIGATOR
References: