A Study for Post op Inflammation After Cataract Surgery

NCT05665270 | Unknown Phase 4 FDA Drug

• 1 other identifier: WCG IRB Protocol #20225859
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Absence of anterior chamber cells

  SUN Scale (0 minimum/better to 4 maximum/ worse)

  at Day 14

Secondary Outcomes (12)

• BCVA

  Baseline (day 8) to day 37

• Number of subjects requiring rescue steroid

  Day 8 to Day 37

• Number and Percentage of subjects with complete absence of cell

  Day 8 to 37

• Measuring Cell

  Day 8, 14, 37

• Measuring Flare

  Day 8, 14, 37

Study Arms (2)

Dextenza

EXPERIMENTAL

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

Prednisolone Acetate

ACTIVE COMPARATOR

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%

Interventions

Dextenza 0.4Mg Ophthalmic Insert DRUG

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.

Dextenza

Prednisolone Acetate 1% DRUG

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.

Prednisolone Acetate

Eligibility Criteria

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

You may qualify if:

• Subjects will be eligible for study participation if they:
• 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.
• Are willing and able to comply with clinic visits and study related procedures
• Are willing and able to sign the informed consent form
• Patients age 18yo+

You may not qualify if:

• Subjects are not eligible for study participation if they:
• Have active infectious systemic disease
• Have active infectious ocular or extraocular disease
• Have an obstructed nasolacrimal duct in the study eye(s) (dacryocystitis)
• Have known hypersensitivity to dexamethasone or are a known steroid responder
• Have a history of ocular inflammation or macular edema
• Are currently being treated with immunomodulating agents in the study eye(s)
• Are currently being treated with immunosuppressants and/or oral steroids
• Are currently being treated with corticosteroid implant (i.e. Ozurdex)
• Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye
• Have a history of complete punctal occlusion in one or both punctum
• Currently use topical ophthalmic steroid medications
• Are currently pregnant or nursing.
• Are unwilling or unable to comply with the study protocol
• 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

Sponsors & Collaborators

• Wyse Eyecare: lead

Study Sites (1)

Wyse Eyecare

Northbrook, Illinois, 60062, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Calcium Dobesilate

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 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.

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: December 27, 2022
• Study Start: January 30, 2023
• Primary Completion: October 31, 2023
• Study Completion: December 15, 2023
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)