DEXTENZA: Efficacy of Dextenza Insert in Upper vs Lower Punctum Following Cataract Surgery With PCIOL.

Sponsor

Iworks Laser and Vision Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05372315

Collaborator

Ocular Therapeutix, Inc. (Industry)

Enrollment

Location

Arms

3.5

Anticipated Duration (Months)

22.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Drug: Dextenza 0.4Mg Ophthalmic Insert	Phase 4

Detailed Description

This is a randomized, controlled study to evaluate the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Each subject's participation is expected to last for approximately 1 month and will be required to complete six scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 8, Day 14 and Day 30.Each subject's participation is expected to last for approximately 1 month and will be required to complete six scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 8, Day 14 and Day 30.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment With an Intracanalicular Dexamethasone (0.4mg) Ophthalmic Insert in the Operating Room Following Cataract Surgery/Intraocular Lens Implant (IOL) With or Without iStent/Hydrus/Goniotomy When Placed in the Lower Punctum vs the Upper Punctum

Actual Study Start Date :

Jun 15, 2022

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Group 1 DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use Group 1 (up to 40 eyes) will receive the insert in the lower punctum on the day of surgery in the OR.	Drug: Dextenza 0.4Mg Ophthalmic Insert (dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis.
Other: Group 2 DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use Group 2 (up to 40 eyes) will receive the insert in the upper punctum on the of surgery in the OR.	Drug: Dextenza 0.4Mg Ophthalmic Insert (dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis.

Arm

Intervention/Treatment

Other: Group 1

DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use Group 1 (up to 40 eyes) will receive the insert in the lower punctum on the day of surgery in the OR.

Drug: Dextenza 0.4Mg Ophthalmic Insert

(dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis.

Other: Group 2

DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use Group 2 (up to 40 eyes) will receive the insert in the upper punctum on the of surgery in the OR.

Drug: Dextenza 0.4Mg Ophthalmic Insert

(dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis.

Outcome Measures

Primary Outcome Measures

Primary Efficacy Endpoint [at Day 8]
Absence of ocular pain at Day 8 as measured by ocular pain assessment numerical grading scale (0 to 10).
Primary Efficacy Endpoint [at Day 14]
Absence of anterior chamber cells at Day 14 as measured by Summed Ocular Inflammation Score (0 to 4).

Secondary Outcome Measures

Secondary Efficacy Endpoint [up to 30 days]
Record insert retention up to 30 days
Secondary Efficacy Endpoint [baseline, Day 8 and Day 30]
Dry eye severity as measured by VAS at baseline, Day 8 and Day 30
Secondary Efficacy Endpoint [Day 0]
Physician ease of insertion and visualization. Number of attempts to successfully insert Dextenza
Secondary Efficacy Endpoint [Day 1, 8, 14, 30]
Mean change in BCVA from Baseline Number and percentage of subjects with complete absence of pain Number and percentage of subjects with complete absence of cell Measuring cell, pain, and flare

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Subjects will be eligible for study participation if they:

Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes with or without iStent/Hydrus/Goniotomy.
Are willing and able to comply with clinic visits and study related procedures.
Are willing and able to sign the informed consent form.
Not pregnant.

Subjects are not eligible for study participation if they:

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 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.
Have active infectious systemic disease.
Have active infectious ocular or extraocular disease.
Have unobstructed nasolacrimal duct in the study eye(s) (dacrocystitis).
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 an/or oral steroids.
Are Pregnant or breast-feeding or wish to become pregnant during the length of study participation.