Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment

Sponsor
Midwest Eye Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04464629
Collaborator
Ocular Therapeutix, Inc. (Industry)
10
Enrollment
1
Location
2
Arms
5.6
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate: how will pseudophakic patients respond in terms of objective and subjective outcomes, when treated with Dextenza compared to topical prednisolone acetate following gas bubble repair and laser for RD.

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

Detailed Description

Subjects who have given informed consent and determined to be eligible at screening will be randomized in a 1:1 ratio to DEXTENZA (placed once in the lower punctum) or the use of topical Prednisolone acetate 1% drops (four times daily). They will be observed for a period of 3-months for both pain and inflammation of the eye.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Assessing the Efficacy and Safety of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment
Actual Study Start Date :
Jul 14, 2020
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: Intracanalicular Sustained Release Dexamethasone, 0.4 mg

Intracanalicular dexamethasone insert contains 0.4 mg dexamethasone and is designed to provide a sustained and tapered release of therapeutic levels of dexamethasone to the ocular surface for up to 30 days for the reduction of post-surgical inflammation and pain associated with ocular surgery.

Drug: Dextenza
Intracanalicular sustained release dexamethasone insert 0.4 mg

Active Comparator: topical prednisolone acetate 1%.

Drug: Prednisolone Acetate
Topical Prednisolone acetate 1% ophthalmic suspension

Outcome Measures

Primary Outcome Measures

  1. Mean change in pain score [30 Days]

    Average change in pain based on whats reported on the Ocular Pain Assessment

  2. Post-op pain scores [30 Days]

    Ocular Pain Assessment: Measured on a scale from 0-10 where 0 (minimum) is no pain and 10 (maximum) is extreme pain. High reported pain means a worse outcome.

Secondary Outcome Measures

  1. Mean change in anterior chamber cell and flare score [30 days]

    Post op inflammation scores as measured on a scale of 0-4: Anterior Chamber Cell Count (Absence of cell to be defined as a grade of: 0-0.5, 4 being the maximum) and Anterior Chamber Flare Score (0 is the minimum, and 4 is the maximum). High reported cell and flare means a worse outcome.

  2. Cystoid Macular Edema [30 days]

    Amount of central thickness macular swelling as measured by Optical Coherence Tomography (OCT)

  3. Best Corrected Visual Acuity [90 days]

    As measured on ETDRS

  4. Physician Ease of Dextenza insertion [Day 1]

    The investigator will grade the level of ease of insertion of the intracanalicular insert on a 0 to 10-point (0 being the minimum and 10 being the maximum) scale with 0 being very easy insertion and 10 being very hard. Difficult insertion means a worse outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Pseudophakic

  • Retinal Detachment

  • Age 18 years and older

  • Scheduled for gas bubble repair and laser surgery following retinal detachment

  • 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.

  • Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)

  • Active infectious systemic disease

  • Active infectious ocular or extraocular disease

  • Obstructed nasolacrimal duct in the study eye(s)

  • Hypersensitivity to dexamethasone

  • Patients being treated with immunomodulating agents in the study eye(s)

  • Patients being treated with immunosuppressants and/or oral steroids

  • Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Midwest Eye InstituteIndianapolisIndianaUnited States46290

Sponsors and Collaborators

  • Midwest Eye Institute
  • Ocular Therapeutix, Inc.

Investigators

  • Principal Investigator: Neil Finnen, MD, Midwest Medical Advisors, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Neil Finnen, MD, Principal Investigator, Midwest Eye Institute
ClinicalTrials.gov Identifier:
NCT04464629
Other Study ID Numbers:
  • The FINNEN Study
First Posted:
Jul 9, 2020
Last Update Posted:
Sep 2, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 2, 2020