In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery (Prepare)

August 25, 2021 updated by: Mitchel Ibach
To evaluate the clinical outcomes with optometrist pre-surgical insertion of DEXTENZA in the clinical office setting in patients undergoing same-day cataract surgery compared to standard of care steroid therapy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 18 years of age or older, undergoing routine, uncomplicated, sequential bilateral cataract surgery.
  • Willing and able to comply with clinic visits and study related procedures
  • Willing and able to sign the informed consent form

Exclusion Criteria:

  • Patients under the age of 18.
  • Patients who are pregnant (must be ruled out in women of childbearing age with pregnancy test).
  • Active infectious ocular or systemic disease.
  • Patients with active infectious ocular or extraocular disease.
  • Patients actively treated with local or systemic immunosuppression including systemic corticosteroids.
  • Patients with known hypersensitivity to Dexamethasone.
  • Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator.
  • Patients with proliferative diabetic retinopathy or uncontrolled diabetes as deemed by an A1C > 10.0.
  • Patients with a history of ocular inflammation or macular edema.
  • Patients with a pre-existing epiretinal membrane (ERM)
  • Patients with allergy or inability to receive intracameral antibiotic.
  • Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day The PREPARE Study (V1) February, 2021 Page 27 CONFIDENTIAL
  • Patients with a corticosteroid implant (i.e. Ozurdex).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A Dextenza
Drug: Dextenza 0.4Mg Ophthalmic Insert
The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.
Active Comparator: Group B Topical Prednisolone
Drug: Topical Prednisolone
Standard of care topical drop treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean anterior chamber cell/flare score
Time Frame: post-op Day 1
Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 + (SUN Working Group Grading Scheme)
post-op Day 1
Mean anterior chamber cell/flare score
Time Frame: post-op Day 7
Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 + (SUN Working Group Grading Scheme)
post-op Day 7
Mean anterior chamber cell/flare score
Time Frame: post-op Week 4.
Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 + (SUN Working Group Grading Scheme)
post-op Week 4.
Mean pain score
Time Frame: post-op Day 1
Mean pain score measured by Visual Analog Score numerical grading scale 0-10
post-op Day 1
Mean pain score
Time Frame: post-op Day 7
Mean pain score measured by Visual Analog Score numerical grading scale 0-10
post-op Day 7
Mean pain score
Time Frame: post-op Week 4
Mean pain score measured by Visual Analog Score numerical grading scale 0-10
post-op Week 4
Patient preference
Time Frame: post-op Week 4
As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) Questionnaire
post-op Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of increased intraocular pressure (IOP) >10mmHg above baseline
Time Frame: postop Day 1
Incidence of increased intraocular pressure (IOP) >10mmHg above baseline as measured by Goldmann Applanation Tonometer
postop Day 1
Incidence of increased intraocular pressure (IOP) >10mmHg above baseline
Time Frame: postop Day 7
Incidence of increased intraocular pressure (IOP) >10mmHg above baseline as measured by Goldmann Applanation Tonometer
postop Day 7
Incidence of increased intraocular pressure (IOP) >10mmHg above baseline
Time Frame: postop Week 4
Incidence of increased intraocular pressure (IOP) >10mmHg above baseline as measured by Goldmann Applanation Tonometer
postop Week 4
Incidence of Cystoid Macular Edema (CME)
Time Frame: post-op Week 4
Incidence of Cystoid Macular Edema (CME) as measured by optical coherence tomography (OCT)
post-op Week 4
Physician Ease of Use
Time Frame: Day 0
Physician Ease of Use Survey following dexamethasone intracanalicular placement on Surgical Visit
Day 0
Eye Drop Burden
Time Frame: post-op Day 7
Eye Drop Burden Questionnaire numerical grading scale of 1-5
post-op Day 7
Eye Drop Burden
Time Frame: post-op Week 4
Eye Drop Burden Questionnaire numerical grading scale of 1-5
post-op Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitchel Ibach

Collaborators

Ocular Therapeutix, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 23, 2021

Primary Completion (Anticipated)

July 27, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

August 2, 2021

First Submitted That Met QC Criteria

August 25, 2021

First Posted (Actual)

August 26, 2021

Study Record Updates

Last Update Posted (Actual)

August 26, 2021

Last Update Submitted That Met QC Criteria

August 25, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The PrePARe Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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