A Study for Post op Inflammation After Cataract Surgery | NCT05665270

Studies
A Study for Post op Inflammation After Cataract Surgery

NCT05665270

Sponsor

Wyse Eyecare

Status

Unknown status

Last Update Posted

Apr 26, 2023Actual

Enrollment

40Estimated

Phase

Phase 4

Conditions

Cataract

Interventions

Dextenza 0.4Mg Ophthalmic Insert
Prednisolone Acetate 1%

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2023Actual

Primary Completion Date

Oct 31, 2023Estimated

Completion Date

Dec 15, 2023Estimated

First Submitted Date

Nov 10, 2022

First Submission Date that Met QC Criteria

Dec 15, 2022

First Posted Date

Dec 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2023

Last Update Posted Date

Apr 26, 2023Actual

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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+

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Wyse Eyecare		Northbrook	Illinois	60062	United States

ID	Term
D002386	Cataract

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

ID	Term
D002123	Calcium Dobesilate

ID	Term
D001557	Benzenesulfonates
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Intervention Model Description

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.