The PRIME Study: A Randomized, Controlled, Prospective Study

NCT ID: NCT04549935

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-14
• Study Completion Date: 2021-08-27

Brief Summary

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.

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.

Conditions

Patient Preference; Patient Outcomes; Post-Operative Inflammation; Grade of Post-Operative Cystoid Macular Edema; Rate of Post-Operative Cystoid Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Dextenza

Intervention Type: DRUG

Dextenza 0.4mg

Group B Topical Prednisolone

Drug: Topical Prednisolone Standard of care topical drop treatment

Group Type: ACTIVE_COMPARATOR

Topical Prednisolone

Intervention Type: DRUG

Standard of care topical drop treatment

Interventions

Dextenza

Dextenza 0.4mg

Intervention Type: DRUG

Topical Prednisolone

Standard of care topical drop treatment

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vance Thompson Vision - MT

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Briana Parker

Bozeman, Montana, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Briana Parker

Role: primary

briana.parker@vancethompsonvision.com

406-599-5961

Keeley Puls

Role: backup

kpuls@vancethompsonvision.com

605 371-7075

Other Identifiers

The PRIME Study

Identifier Type: -

Identifier Source: org_study_id