NCT04464629

Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment

Assessing the Efficacy and Safety of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Midwest Eye Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate: how will pseudophakic patients respond in terms of objective and subjective outcomes, when treated with Dextenza compared to topical prednisolone acetate following gas bubble repair and laser for RD.

Detailed description

Subjects who have given informed consent and determined to be eligible at screening will be randomized in a 1:1 ratio to DEXTENZA (placed once in the lower punctum) or the use of topical Prednisolone acetate 1% drops (four times daily). They will be observed for a period of 3-months for both pain and inflammation of the eye.

Conditions

• Retinal Detachment

Interventions

Type	Name	Description
DRUG	Dextenza	Intracanalicular sustained release dexamethasone insert 0.4 mg
DRUG	Prednisolone Acetate	Topical Prednisolone acetate 1% ophthalmic suspension

Timeline

• Start date: 2020-07-14
• Primary completion: 2023-01-25
• Completion: 2023-01-25
• First posted: 2020-07-09
• Last updated: 2023-08-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study