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

NCT05372315 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-08-23

Study results available
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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.

Conditions

  • Cataract

Interventions

DRUG

Dextenza 0.4Mg Ophthalmic Insert

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

Sponsors & Collaborators

  • Ocular Therapeutix, Inc.

    collaborator INDUSTRY

  • Iworks Laser and Vision Center

    lead OTHER

Principal Investigators

  • Patrick L Spencer, DO · Iworks Laser & Vision Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2022-10-31
Completion
2022-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05372315 on ClinicalTrials.gov