NCT04549935

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)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Vance Thompson Vision - MT · Academic / Other
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Dextenza	Dextenza 0.4mg
DRUG	Topical Prednisolone	Standard of care topical drop treatment

Timeline

• Start date: 2020-09-14
• Primary completion: 2021-08-27
• Completion: 2021-08-27
• First posted: 2020-09-16
• Last updated: 2020-09-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study