NCT04205916

A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery

A Prospective Trial Evaluating a Intracanalicular Insert Delivery System Compared to Traditional Topical Drops in Controlling Post-operative Pain and inFlammation in Subjects Undergoing Sequential Bilateral Cataract Surgery

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Ophthalmic Consultants of Long Island · Academic / Other
• Sex: All
• Age: 22 Years – 100 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and ocular efficacy of Dextenza in combination with an intracameral antibiotic and NSAID in controlling post-operative ocular pain and inflammation compared to standard of care topical therapy in patients undergoing bilateral cataract surgery.

Detailed description

This is a randomized, self-controlled prospective clinical study. On initial consultation within one month of scheduled cataract surgery, each study subject will be randomized by a random number generator to receive one of two treatment groups, either experimental or control in the first eye. The second eye will undergo cataract surgery 2 weeks later and will be treated with the other treatment group: Experimental Group: A total of 50 study subjects (50 eyes) will receive Dextenza dexamethasone intracanalicular insert placed in the lower punctum of their scheduled surgical eye at the time of surgery and will receive intracameral ketorolac during the procedure and 50 micrograms of intracameral moxifloxacin at the conclusion of the procedure. Control Group: A total of 50 study subjects (50 eyes) will receive topical moxifloxacin 0.5% qid 1 day prior to surgery and for ten days postoperatively, ketorolac 0.5% qid 1 day prior to surgery and for 1 month postoperatively, and prednisolone acetate 1.0% qid starting at the conclusion of cataract surgery for 2 weeks and bid for 2 weeks in their scheduled surgical eye.

Conditions

• Patient Preference

Interventions

Type	Name	Description
DRUG	Dexamethasone	Drugs to be administer during cataract surgery to experimental group
OTHER	Standard of care surgery	Standard method used for surgery and the use of post operative drops

Timeline

• Start date: 2019-11-04
• Primary completion: 2020-06-30
• Completion: 2020-12-01
• First posted: 2019-12-20
• Last updated: 2019-12-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study