The PRIME Study: A Randomized, Controlled, Prospective Study

A Randomized, Controlled, 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 in Patients Who Plan to Undergo Refractive Lens Exchange (RLE)

To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin and risk of cystoid macular edema post-operatively.

Study Overview

• Status: Unknown
• Conditions: Patient Preference; Post-Operative Inflammation; Patient Outcomes; Grade of Post-Operative Cystoid Macular Edema; Rate of Post-Operative Cystoid Macular Edema
• Intervention / Treatment: Drug: Topical Prednisolone; Drug: Dextenza

Detailed Description

A Randomized, Controlled, Prospective Study design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, TID 1 week, BID 1 week, and QD 1week, following bilateral RLE surgery. All eyes will receive topical moxifloxacin QID for one week and topical Ilevro QD for 4 weeks. Moxifloxacin and Ilevero are used in post-op regardless of the research. Post-operative evaluations to be performed on Day 1, Day 7, and 1 Month.

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

Contacts and Locations

Study Locations

• United States
  • Montana
    • Bozeman, Montana, United States, 59718
      • Recruiting
      • Briana Parker
      • Contact: Briana Parker; Phone Number: 406-599-5961; Email: briana.parker@vancethompsonvision.com
      • Contact: Keeley Puls; Phone Number: 605 371-7075; Email: kpuls@vancethompsonvision.com
      • Sub-Investigator: Seirra Steiner, OD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Any adult patient who is planned to undergo bilateral RLE surgery with BCVA 20/30 or better
• 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 22 or above the age of 75
• Patients who are pregnant (must be ruled out in a women of child-bearing age with pregnancy test).
• Patients with active infectious ocular or extraocular disease.
• Patients actively treated with local or systemic immunosuppression including systemic corticosteriods
• Paitents with know hypersensitivity to Dexamethasone
• Patients with severe disease that warrants critical attentino, 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) grater than 1,200 mg/day
• Patient with a corticosteriod implant (i.e. Ozurdex).
• Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group A Dextenza; Drug: Dextenza 0.4mg Opthalmic 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 risks for improper corticosteriod tapering and unwanted peaks and troughs in drug concentration.	Drug: Dextenza; Dextenza 0.4mg
ACTIVE_COMPARATOR: Group B Topical Prednisolone; Drug: Topical Prednisolone Standard of care topical drop treatment	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 adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) survey (This is measured on a scale of 1-10 with 10 being a worse outcome)	Through Month 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of eyes that have CME (Cystoid macular edema) post-operatively	Measured by OCT (Optical Coherence Tomography )	Through Month 1
Mean pain score per eye (Group A vs Group B)	Measured by Visual Analog Scale (0-10, 10 being the worst outcome)	Through Month 1
Incidence of post-operative corneal haze	measured by OCT (Optical Coherence Tomography)	Through Month 1
Grade of post-operative corneal haze	measured by OCT (Optical Coherence Tomography)	Through Month 1
Anterior chamber cell count	measured by SUN Working Group Grading Scheme	Through Month 1
Uncorrected Visual Acuity	measured by ETDRS chart a 4m	Through Month 1
Best Corrected Visual Acuity	measured by ETDRS chart a 4m	Through Month 1

Collaborators and Investigators

• Sponsor: Vance Thompson Vision - MT

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 14, 2020
• Primary Completion (ANTICIPATED): August 27, 2021
• Study Completion (ANTICIPATED): August 27, 2021

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (ACTUAL): September 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Inflammation; Macular Edema; Edema; 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: The PRIME Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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