DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK Surgery (AtLAS)

DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK

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 LASIK surgery.

Study Overview

• Status: Unknown
• Conditions: Refractive Surgery
• Intervention / Treatment: Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Topical Prednisolone

Detailed Description

This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate the outcomes of patients undergoing bilateral LASIK surgery with the treatment of a dexamethasone intracanalicular insert compared to standard of care topical prednisolone. All eyes will receive treatment. Additionally, all eyes will receive topical moxifloxacin QID for 1 week.

Twenty patient eyes undergoing bilateral LASIK surgery will be randomized to receive either Dextenza (Group A) OR standard of care prednisolone acetate 1% QID for 1 week, BID for 1 week (Group B). The contralateral eye will receive treatment with either DEXTENZA or topical prednisolone as a comparator based on randomization of first eye to Group A or Group B. Post-operative evaluations will be performed on Day 1, Day 7, and Month 1 following surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • W. Fargo, North Dakota, United States, 58078
      • Recruiting
      • Vance Thompson Vision ND
      • Contact: Sarah Thiede; Phone Number: 701-566-5390; Email: sarah.thiede@vancethompsonvision.com
      • Principal Investigator: Michael Greenwod, MD
      • Sub-Investigator: Nicholas Risbrudt, OD
      • Contact: Jake Hutchison; Phone Number: 701-566-5390; Email: jake.hutchison@vancethompsonvision.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Any adult patient who is planned to undergo bilateral LASIK surgery.
• Refractive error between the 2 eyes of 2 Diopters or less
• 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 choose to have monovision after LASIK
• Patients with corneal pathology that may interfere with LASIK outcomes
• 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 topical antibiotic.
• Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day
• Patients with a corticosteroid implant (i.e. Ozurdex).
• Active or history of chronic or recurrent inflammatory eye disease in either eye
• Ocular pain in either eye
• Proliferative diabetic retinopathy in either eye
• Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye
• Laser or incisional ocular surgery during the study period and 6 months prior in either eye
• History of cauterization of the punctum

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Preference	As measured by COMTOL adapted survey.	Through Month 1 (Day 28 +/- 3 days)
Patient Comfort	As measured by SPEED Questionnaire.	Through Month 1 (Day 28 +/- 3 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Surface Health	As measured by corneal staining.	Through Month 1 (Day 28 +/- 3 days)
Visual Outcomes	As measured by uncorrected Visual Acuity.	Through Month 1 (Day 28 +/- 3 days)
Ocular Pain	As measured by Ocular Pain Assessment.	Through Month 1 (Day 28 +/- 3 days)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoints	As measured by intraocular pressure increase of 10 mm Hg or greater from baseline.	Through Month 1 (Day 28 +/- 3 days)
Safety Endpoints	As measured by proportion of eyes rescued with additional topical prednisolone treatment or increased frequency of dosing.	Through Month 1 (Day 28 +/- 3 days)
Safety Endpoints	As measured by occurrence of adverse events.	Through Month 1 (Day 28 +/- 3 days)

Collaborators and Investigators

• Sponsor: Vance Thompson Vision

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2020
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 24, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisolone
• Other Study ID Numbers: ATLAS2020

Drug and device information, study documents

• 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