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

Refractive Surgery Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04396990
• Other study ID #: The RESTORE Study
• Status: Completed
• Start date: June 8, 2020
• Est. completion date: September 28, 2020

Study information

• Verified date: July 2023
• Source: Vance Thompson Vision
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 28, 2020
• Est. primary completion date: September 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Refractive Surgery

Intervention

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.
• Topical Prednisolone
Standard of care topical drop treatment

Locations

Country	Name	City	State
United States	Vance Thompson Vision	Sioux Falls	South Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Vance Thompson Vision	Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Eyes Epithelialized at Day 3	The percentage of eyes with fully healed epithelium at post-op day 3	Post-Operative Day 3
Secondary	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
Secondary	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
Secondary	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)
Secondary	Uncorrected Distance Visual Acuity	measured using the ETDRS acuity chart at 4 meters recorded in logMAR.	Month 1 and Month 3.
Secondary	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