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Related Experiment Video

Updated: Jun 30, 2025

Use of Rabbit Eyes in Pharmacokinetic Studies of Intraocular Drugs
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Dexamethasone Intracanalicular Insert for Clinically Significant Aqueous-Deficient Dry Eye: A Randomized Controlled

Michael X Lin1, Lee Guo2, Ian J Saldanha3

  • 1The Ocular Surface Disease Clinic, The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Maryland School of Medicine, Baltimore, Maryland.

Ophthalmology
|March 16, 2024
PubMed
Summary

A new dexamethasone intracanalicular insert effectively reduced ocular staining in patients with dry eye disease. This dropless treatment may be a viable option when topical steroids are indicated, though it can increase intraocular pressure.

Keywords:
Clinical trialDry eyeTreatment

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Area of Science:

  • Ophthalmology
  • Dry Eye Disease Research
  • Ocular Therapeutics

Background:

  • Dry eye disease (DED) is a prevalent condition affecting millions worldwide.
  • Aqueous-deficient dry eye (ADDE) is a subtype characterized by insufficient tear production.
  • Current treatments for ADDE include artificial tears, anti-inflammatory medications, and punctal plugs.

Purpose of the Study:

  • To assess the efficacy and safety of a novel dexamethasone 0.4-mg intracanalicular insert for treating clinically significant ADDE.
  • To evaluate the insert as a potential dropless therapeutic option for DED management.

Main Methods:

  • A single-center, double-masked, randomized controlled trial was conducted with 75 adult patients diagnosed with ADDE.
  • Participants received either the dexamethasone insert (elution time: 30 days) or a sham collagen plug in a 1:1 ratio, with fellow eyes receiving the alternative treatment.
  • Efficacy was measured by dry eye parameters (ocular staining, Schirmer's wetting) and patient-reported symptoms, while safety was assessed via intraocular pressure (IOP) monitoring.

Main Results:

  • The dexamethasone insert significantly reduced corneal and conjunctival staining at week 4 compared to the sham treatment.
  • While patients reported less dryness at week 4, no statistically significant differences in overall patient-reported symptoms were observed between groups.
  • An increased incidence of elevated IOP (5-10 mmHg) was noted in the dexamethasone-treated eyes at week 4, all manageable with topical beta-blockers.

Conclusions:

  • The dexamethasone intracanalicular insert demonstrates potential as an effective dropless treatment for ADDE, particularly when topical steroid therapy is considered appropriate.
  • Clinicians should monitor intraocular pressure in patients using this insert due to the observed risk of IOP elevation.