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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

CIMPLIFY Trial 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

CIMPLIFY Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient Preference
Secondary outcome measures
Adverse Events
Best Corrected Visual Acuity (BCVA)
Distance Visual Acuity (VA)
+4 more

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915
2%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant

CIMPLIFY 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

Find a Location

Who is running the clinical trial?

Ophthalmic Consultants of Long IslandLead Sponsor
8 Previous Clinical Trials
270 Total Patients Enrolled
Ocular Therapeutix, Inc.Industry Sponsor
53 Previous Clinical Trials
5,527 Total Patients Enrolled
Eric Donnenfeld, MDPrincipal InvestigatorPhysician
4 Previous Clinical Trials
256 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery
2019. "A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04205916.
All > Cataract
~9 spots leftby Apr 2025
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