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Experimental Group for Patient Preference (CIMPLIFY Trial)

Phase 4

Recruiting

Led By Eric Donnenfeld, MD

Research Sponsored by Ophthalmic Consultants of Long Island

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 month / 60 days visit for second eye

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

All Individual Drugs Already Approved

Approved for 60 Other Conditions

No Placebo-Only Group

Summary

This trial is testing whether using Dextenza in combination with an intracameral antibiotic and NSAID can control post-operative ocular pain and inflammation better than using standard of care topical therapy.

Eligible Conditions

Patient Preference

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 month / 60 days visit for second eye

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 month / 60 days visit for second eye

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 month / 60 days visit for second eye for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient Preference

Secondary study objectives

Adverse Events

Best Corrected Visual Acuity (BCVA)

Distance Visual Acuity (VA)

+4 more

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915

Deep Vein Thrombosis

Cerebrospinal fluid leak

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketorolac

FDA approved

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