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Completed

NCT Number: NCT04396990

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

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.

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Key information

Conditions

Refractive Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Topical Prednisolone

Drug

Standard of care topical drop treatment

Primary outcomes

  1. Patient Preference

    Time frame: Through Month 1 (Day 28 +/- 3 days)

    Primary outcome of patient reference of dexamethasone insert versus topical steroid as measured by adapted Comparison of Ophthalmic Medications for Tolerability (COMToL) questionnaire.

Secondary outcomes

  1. Percentage of Eyes Epithelialized at Day 3

    Time frame: Post-Operative Day 3

    The percentage of eyes with fully healed epithelium at post-op day 3

  2. Percentage of Eyes Fully Epithelialized at Day 4 Postoperative

    Time frame: Postoperative Day 4

    The percentage of eyes with fully healed epithelium at day 4 post-operative

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

    Time frame: Day 3

    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.

  4. SPEED Questionnaire Results at Baseline and Postoperative Day 28

    Time frame: Pre-op Visit and Month 1 (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.

  5. Uncorrected Distance Visual Acuity

    Time frame: Month 1 and Month 3.

    measured using the ETDRS acuity chart at 4 meters recorded in logMAR.

  6. Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative

    Time frame: Month 1 and Month 3

    Best-corrected distance visual acuity measured using ETDRS acuity chart at 4 meters, recorded in logMAR notation

Sponsors and collaborators

Lead sponsor

Vance Thompson Vision

Other

Collaborators

  • Ocular Therapeutix, Inc.

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 21, 2020
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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