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Corticosteroid

Dextenza 0.4Mg Ophthalmic Insert for Eye Pain

Phase 4

Waitlist Available

Led By Nicole Fram, MD

Research Sponsored by Nicole Fram M.D.

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 assessed on day 30, 60 and 90

Awards & highlights

Study Summary

This trialtests how well a drug works and if it's safe for people after corneal transplant surgery.

Eligible Conditions

Eye Pain
Anterior Uveitis
Glaucoma
Corneal Edema
Corneal Dystrophy
Corneal Transplant

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed on day 30, 60 and 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed on day 30, 60 and 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed on day 30, 60 and 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean change in inflammation (Cell and Flare) scores

Mean change in pain score

Secondary outcome measures

Impact on the practice/medical team of decreasing the drop burden

Mean change in duration to clearing of corneal edema

Mean change in duration to corneal re-epithelization

+1 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: PKP without Dextenza (Controlled)Experimental Treatment1 Intervention

Patients undergoing PKP will receive: topical prednisolone acetate 1% every two hours (6X /day) for 2 weeks, 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter. PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks

Group II: PKP with Dextenza (study)Experimental Treatment2 Interventions

Patients undergoing PKP will receive Dextenza insert with: topical prednisolone acetate 1% 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter. PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks

Group III: DSEK without Dextenza (Controlled)Experimental Treatment1 Intervention

Patients undergoing DSEK will receive: topical prednisolone acetate 1% every two hours (6X /day) for 2 weeks, 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter. PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks

Group IV: DSEK with Dextenza (study)Experimental Treatment2 Interventions

Patients undergoing DSEK will receive Dextenza insert with: topical prednisolone acetate 1% 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter. PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks

Group V: DMEK without Dextenza (Controlled)Experimental Treatment1 Intervention

Patients undergoing DMEK will receive: topical prednisolone acetate 1% every two hours (6X /day) for 2 weeks, 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter. PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks

Group VI: DMEK with Dextenza (study)Experimental Treatment2 Interventions

will receive Dextenza insert with: topical prednisolone acetate 1% 4 times a day for 1 month, 3 times a day for one month, 2 times a day for one month, once a day for one month, then Lotemax once a day thereafter. PolymyxinB/Trimethoprim or Vigamox / Moxifloxacin 4 times a day for 2 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisolone acetate

FDA approved

Dexamethasone

FDA approved

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Nicole Fram M.D.Lead Sponsor

2 Previous Clinical Trials

125 Total Patients Enrolled

2 Trials studying Eye Pain

125 Patients Enrolled for Eye Pain

Nicole Fram, MDPrincipal Investigator - Advanced Vision Care

Advanced Vision Care, Century City Doctors Hospital

Jefferson Medical Coll-Thos Jefferson University (Medical School)

Thos Jefferson University Hospital (Residency)

2 Previous Clinical Trials

320 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacant slots for participants in this clinical trial?

"Correct. Data presented on clinicaltrials.gov confirms that this medical experiment, which was first posted on October 16th 2020, is actively recruiting participants. Approximately 30 patients need to be recruiter from 1 centre."

Answered by AI

Have other trials evaluated the efficacy of Dextenza 0.4Mg Ophthalmic Insert?

"At present, there are 556 clinical investigations taking place for the Dextenza 0.4Mg Ophthalmic Insert with 145 studies in Phase 3. This research is mainly being conducted from Mishawaka, Indiana but can also be found at 18626 other sites worldwide."

Answered by AI

How many participants are eligible to join this clinical research?

"Affirmative, according to clinicaltrials.gov the trial is still open for enrollment and was first published on October 16th 2020 with a most recent update being November 15th 2022. Enrollment of 30 individuals from one medical centre is necessary to complete this investigation."

Answered by AI

What medical condition has Dextenza 0.4Mg Ophthalmic Insert been found to be an effective remedy for?

"The Dextenza 0.4Mg Ophthalmic Insert is frequently utilised to treat ocular inflammation, sympathetic disorders, branch retinal vein occlusion, microbial eye infections and macular edema."

Answered by AI

What aims has this trial been designed to accomplish?

"The primary endpoint evaluated over a 30-day period is the mean difference in pain score. This will be complemented by secondary endpoints such as changes to epithelial defect size, reduction of corneal edema, and impacts on eye drop burden based off questionnaires."

Answered by AI

Has the Dextenza 0.4Mg Ophthalmic Insert been given clearance by the FDA?

"The safety rating of Dextenza 0.4Mg Ophthalmic Insert is 3, reflecting the fact that it has passed Phase 4 trials and is currently approved for medical use."

Answered by AI

Recent research and studies

Journal of Cataract and Refractive SurgeryJournal

Multicenter Randomized Phase 3 Study of a Sustained-release Intracanalicular Dexamethasone Insert for Treatment of Ocular Inflammation and Pain After Cataract Surgery

Tyson, Syd L., Shamik Bafna, Joseph P. Gira, Damien F. Goldberg, Jason J. Jones, Michael P. Jones, Janet K. Kim, et al.. 2019. “Multicenter Randomized Phase 3 Study of a Sustained-release Intracanalicular Dexamethasone Insert for Treatment of Ocular Inflammation and Pain After Cataract Surgery”. Journal of Cataract and Refractive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.jcrs.2018.09.023.

Journal of Cataract and Refractive SurgeryJournal

Multicenter Randomized Phase 3 Study of a Sustained-release Intracanalicular Dexamethasone Insert for Treatment of Ocular Inflammation and Pain After Cataract Surgery

clinicaltrials.govStudy

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Corneal Transplant Surgery

Nicole Fram M.D. 2020. "Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Corneal Transplant Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04521140.