In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery

NCT05023304 | Completed Phase 4 Results FDA Drug

• 1 other identifier: The Prepare Study
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (5)

• Mean Anterior Chamber Cell/Flare Score

  Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 +. The scale used is called the (Standardization of Uveitis Nomenclature) SUN Working Group Grading Scheme. AC cell grading schema. The SUN Working Group defined their two AC grading schemas around these two findings. Importantly, for all grading schemas discussed in this article, an improvement in inflammation is a two-step decrease in grade. A worsening of inflammation occurs with a two-step increase in grade. Grade 0 = 0 cells per high power field or HPF; Grade 0.5+ = 1-5 cells HPF; 1+ = 6-15 HPF; 2+ = 16-25 HPF; 3+ = 26-50 HPF; 4+ \>50.

  Post-op Day 1

• Mean Anterior Chamber Cell/Flare Score

  Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 +. The scale used is called the (Standardization of Uveitis Nomenclature) SUN Working Group Grading Scheme. AC cell grading schema. The SUN Working Group defined their two AC grading schemas around these two findings. Importantly, for all grading schemas discussed in this article, an improvement in inflammation is a two-step decrease in grade. A worsening of inflammation occurs with a two-step increase in grade. Grade 0 = 0 cells per high power field or HPF; Grade 0.5+ = 1-5 cells HPF; 1+ = 6-15 HPF; 2+ = 16-25 HPF; 3+ = 26-50 HPF; 4+ \>50. The higher the HPF, the more inflammation that can negatively impact a patient's outcome.

  Post-op Day 7

• Number of Eyes With No Cell or Flare Measured

  Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 +. The scale used is called the (Standardization of Uveitis Nomenclature) SUN Working Group Grading Scheme. AC cell grading schema. The SUN Working Group defined their two AC grading schemas around these two findings. Importantly, for all grading schemas discussed in this article, an improvement in inflammation is a two-step decrease in grade. A worsening of inflammation occurs with a two-step increase in grade. Grade 0 = 0 cells per high power field or HPF; Grade 0.5+ = 1-5 cells HPF; 1+ = 6-15 HPF; 2+ = 16-25 HPF; 3+ = 26-50 HPF; 4+ \>50. The higher the HPF, the more inflammation that can negatively impact a patient's outcome.

  post-op Week 4.

• Mean Pain Score

  Mean pain score measured by Visual Analog Score numerical grading scale 0(minimum)-10(maximum) 0= absence of pain 10 = highest possible pain A higher number indicates a higher pain value which may impact a subject's outcomes.

  Post-op Day 1

• Patient Tolerability (Defined as Patient Preference)

  As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) Questionnaire. The COMTOL questionnaire is designed to assess the tolerability of topical ophthalmic medications. It consists of several elements that help evaluate the frequency, severity, and impact of common side effects: Section 1: Ocular Side Effects; Section 2: Local Side Effects; Section 3: Visual Function; Section 4: Impact on Quality of Life. Likert scale is used to measure each question. 1=Never, 2=Rarely, 3=Sometimes, 4 = Often, 5= Always. A higher score suggests that the medication is less well-tolerated and may be negatively impacting the patient's daily activities and overall well-being.

  Post-op Week 4

Secondary Outcomes (7)

• Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline

  postop Day 1

• Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline

  Postop Day 7

• Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline

  postop Week 4

• Number of Participants With Post-operative Cystoid Macular Edema (CME)

  post-op Week 4

• Physician Ease of Use

  Day 0

Study Arms (2)

Group A Dextenza

EXPERIMENTAL

Randomized to dexamethasone ophthalmic insert 0.4mg placed prior to cataract surgery, on the day of surgery.

Drug: Dextenza 0.4Mg Ophthalmic Insert

Group B Topical Prednisolone

ACTIVE COMPARATOR

Randomized to topical prednisolone acetate 1% four times per day for one week, three times per day for one week, two times per day for one week, and one time per day for one week starting after 4 hours after surgery.

Drug: Topical prednisolone acetate

Interventions

Dextenza 0.4Mg Ophthalmic Insert DRUG

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.

Group A Dextenza

Topical prednisolone acetate DRUG

Standard of care topical drop regimen with four week taper

Group B Topical Prednisolone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vance Thompson Vision: lead
• Ocular Therapeutix, Inc.: collaborator

Study Sites (1)

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Calcium Dobesilate; prednisolone acetate

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Vance Thompson Vision

keeley.boever@vancethompsonvision.com

1-605-371-7075

Study Officials

• Mitch Ibach, OD

  Vance Thompson Vision

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 26, 2021
• Study Start: August 23, 2021
• Primary Completion: July 27, 2022
• Study Completion: October 1, 2022
• Last Updated: August 17, 2025
• Results First Posted: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)