Prepare: In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery

Sponsor
Mitchel Ibach (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05023304
Collaborator
Ocular Therapeutix, Inc. (Industry)
30
Enrollment
2
Arms
13.3
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Dextenza 0.4Mg Ophthalmic Insert
  • Drug: Topical Prednisolone
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery
Anticipated Study Start Date :
Aug 23, 2021
Anticipated Primary Completion Date :
Jul 27, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Mean anterior chamber cell/flare score [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)

  2. Mean anterior chamber cell/flare score [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)

  3. Mean anterior chamber cell/flare score [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)

  4. Mean pain score [post-op Day 1]

    Mean pain score measured by Visual Analog Score numerical grading scale 0-10

  5. Mean pain score [post-op Day 7]

    Mean pain score measured by Visual Analog Score numerical grading scale 0-10

  6. Mean pain score [post-op Week 4]

    Mean pain score measured by Visual Analog Score numerical grading scale 0-10

  7. Patient preference [post-op Week 4]

    As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) Questionnaire

Secondary Outcome Measures

  1. Incidence of increased intraocular pressure (IOP) >10mmHg above baseline [postop Day 1]

    Incidence of increased intraocular pressure (IOP) >10mmHg above baseline as measured by Goldmann Applanation Tonometer

  2. Incidence of increased intraocular pressure (IOP) >10mmHg above baseline [postop Day 7]

    Incidence of increased intraocular pressure (IOP) >10mmHg above baseline as measured by Goldmann Applanation Tonometer

  3. Incidence of increased intraocular pressure (IOP) >10mmHg above baseline [postop Week 4]

    Incidence of increased intraocular pressure (IOP) >10mmHg above baseline as measured by Goldmann Applanation Tonometer

  4. Incidence of Cystoid Macular Edema (CME) [post-op Week 4]

    Incidence of Cystoid Macular Edema (CME) as measured by optical coherence tomography (OCT)

  5. Physician Ease of Use [Day 0]

    Physician Ease of Use Survey following dexamethasone intracanalicular placement on Surgical Visit

  6. Eye Drop Burden [post-op Day 7]

    Eye Drop Burden Questionnaire numerical grading scale of 1-5

  7. Eye Drop Burden [post-op Week 4]

    Eye Drop Burden Questionnaire numerical grading scale of 1-5

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Mitchel Ibach
  • Ocular Therapeutix, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mitchel Ibach, Principal Investigator, Vance Thompson Vision
ClinicalTrials.gov Identifier:
NCT05023304
Other Study ID Numbers:
  • The Prepare Study
First Posted:
Aug 26, 2021
Last Update Posted:
Aug 26, 2021
Last Verified:
Aug 1, 2021
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 Aug 26, 2021