A Study for Post op Inflammation After Cataract Surgery

A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment

This is a randomized, controlled study to assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert when utilized in conjunction with topical steroids as part of an extended taper steroid regimen following cataract surgery in patients with a history of epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cataract
• Intervention / Treatment: Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Prednisolone Acetate 1%

Detailed Description

There will be approximately 40 eyes with two groups:

Group 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8).

Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week.

Both groups will receive topical Prolensa Qa.m. x 5 weeks and Moxifloxacin TID x 1 week, per investigators preferential treatment regimen.

Each subject's participation is expected to last for approximately 5 weeks and subjects will be required to complete six scheduled visits over the course of the study period: Baseline (Screening Visit Day -1), Operative Visit (Day 0), Day 1, Day 8 (insertion day), Day 14, and Day 37.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Northbrook, Illinois, United States, 60062
      • Wyse Eyecare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Subjects will be eligible for study participation if they:

1. Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes and have a history of epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration.
2. Are willing and able to comply with clinic visits and study related procedures
3. Are willing and able to sign the informed consent form
4. Patients age 18yo+

Exclusion Criteria:

Subjects are not eligible for study participation if they:

1. Have active infectious systemic disease
2. Have active infectious ocular or extraocular disease
3. Have an obstructed nasolacrimal duct in the study eye(s) (dacryocystitis)
4. Have known hypersensitivity to dexamethasone or are a known steroid responder
5. Have a history of ocular inflammation or macular edema
6. Are currently being treated with immunomodulating agents in the study eye(s)
7. Are currently being treated with immunosuppressants and/or oral steroids
8. Are currently being treated with corticosteroid implant (i.e. Ozurdex)
9. Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye
10. Have a history of complete punctal occlusion in one or both punctum
11. Currently use topical ophthalmic steroid medications
12. Are currently pregnant or nursing.
13. Are unwilling or unable to comply with the study protocol
14. Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) or if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dextenza; Group 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8).	Drug: Dextenza 0.4Mg Ophthalmic Insert; Group 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8). Both groups will receive topical Prolensa Qa.m. x 5 weeks and Moxifloxacin TID x 1 week, per investigators preferential treatment regimen.
Active Comparator: Prednisolone Acetate; Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week.	Drug: Prednisolone Acetate 1%; Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week. Both groups will receive topical Prolensa Qa.m. x 5 weeks and Moxifloxacin TID x 1 week, per investigators preferential treatment regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of anterior chamber cells	SUN Scale (0 minimum/better to 4 maximum/ worse)	at Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BCVA	Snellen Chart	Baseline (day 8) to day 37
Number of subjects requiring rescue steroid	Addition of steroid treatment	Day 8 to Day 37
Number and Percentage of subjects with complete absence of cell	SUN Scale	Day 8 to 37
Measuring Cell	Sun Scale (0 minimum/better to 4 maximum/ worse)	Day 8, 14, 37
Measuring Flare	Sun Scale (0 minimum/better to 4 maximum/ worse)	Day 8, 14, 37
Eye Pain	VAS Questionnaire 0 no pain to 10 worst possible pain	Day 8, 14, 37
Ease of insertion	Noted as Easy, Moderate, or Difficult	Day 8
Ease of Visualization	Noted as Easy, Moderate, or Difficult	Day 8, 14, 37
Number of attempts to successfully insertion	Note Number of attempts to successfully insert as 1,2,3 attempts	Day 8
Dry Eye	SPEED Survey Lower score indicates less dryness which is better than a higher score	Day 8, Day 14, and Day 37.
Central Macular Thickness	Mean change of Central Macular Thickness by Optical coherence tomography	Baseline to Day 37
Insert Retention	By slit lamp exam if insert is visualized or not	Day 8 to 37 days

Collaborators and Investigators

• Sponsor: Wyse Eyecare

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Anticipated): October 31, 2023
• Study Completion (Anticipated): December 15, 2023

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: WCG IRB Protocol #20225859

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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