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

Recruiting in Palo Alto (17 mi)

Overseen byEric Donnenfeld, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Ophthalmic Consultants of Long Island

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eric Donnenfeld, MD

Principal Investigator

Physician

Eligibility Criteria

Inclusion Criteria

A male or female subject in good general health (as determined by the Investigator), > 22 years of age at the time of the screening visit

A subject must be willing and able to sign informed consent

A woman of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening and must be practicing an adequate method of birth control. Acceptable methods of birth control include intrauterine device (IUD), oral, dermal ("patch"), implant or injected contraceptives; tubal ligation; and barrier methods with spermicide.

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Treatment Details

Interventions

Dexamethasone (Corticosteroid)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental GroupExperimental Treatment1 Intervention

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.

Group II: Control GroupActive Control1 Intervention

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.