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OpenTrials
Completed

NCT Number: NCT05372315

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Iworks Laser & Vision Center

Dayton, Ohio, 45405, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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.

Exclusion criteria

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.

Treatment and study plan

Dextenza 0.4Mg Ophthalmic Insert

Drug

(dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery.

Primary outcomes

  1. Participants With Complete Absence of Ocular Pain at Day 8

    Time frame: at Day 8

    Participant reported ocular pain on a scale of (0-10) with zero (0) equaling no pain and ten(10) equaling maximal pain on day 8.

  2. Participants With Zero Cells on Day 14

    Time frame: at Day 14

    Proportion of of participants with complete absence of anterior chamber cell at Day 14 as measured by Summed Ocular Inflammation Score (0-4).

Secondary outcomes

  1. Ease of Insertion

    Time frame: Day 0

    Rated as Easy, Moderate, Difficult

  2. Attempts to Achieve Successful Insertion

    Time frame: Day 0

    Number of attempts to insert the dexamethasone insert in the upper or lower punctum.

Sponsors and collaborators

Lead sponsor

Iworks Laser and Vision Center

Other

Collaborators

  • Ocular Therapeutix, Inc.

Registry information

Official study 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).

Acronym: DEXTENZA

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 12, 2022
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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