Dexamethasone Intracanalicular Insert for Clinically Significant Aqueous-Deficient Dry Eye: A Randomized Controlled Trial

Michael Lin; Lee Guo; Ian J Saldanha; Shanna VanCourt; Julia Zeng; Sezen Karakus; Michelle Hessen; Gavin Li; Esen K Akpek

doi:10.1016/j.ophtha.2024.03.010

Dexamethasone Intracanalicular Insert for Clinically Significant Aqueous-Deficient Dry Eye: A Randomized Controlled Trial

Ophthalmology. 2024 Mar 14:S0161-6420(24)00186-6. doi: 10.1016/j.ophtha.2024.03.010. Online ahead of print.

Authors

Michael Lin¹, Lee Guo², Ian J Saldanha³, Shanna VanCourt², Julia Zeng⁴, Sezen Karakus², Michelle Hessen², Gavin Li⁵, Esen K Akpek⁶

Affiliations

¹ The Ocular Surface Disease Clinic, The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; University of Maryland School of Medicine, Baltimore, Maryland, USA.
² The Ocular Surface Disease Clinic, The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
³ Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
⁴ The Ocular Surface Disease Clinic, The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; Stritch School of Medicine - Loyola University, Chicago, Illinois, USA.
⁵ The Ocular Surface Disease Clinic, The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; Icahn School of Medicine at Mount Sinai, New York, New York, USA.
⁶ The Ocular Surface Disease Clinic, The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. Electronic address: esakpek@jhmi.edu.

PMID: 38492864
DOI: 10.1016/j.ophtha.2024.03.010

Abstract

Purpose: To evaluate a commercially available dexamethasone intracanalicular insert to treat dry eye.

Design: Single-center, double-masked, randomized controlled trial.

Participants: Patients with clinically significant aqueous-deficient dry eye [combined ocular surface staining score ≥3 (0-12), corneal fluorescein staining ≥2 (0-6), and Schirmer's wetting <10 mm at 5 minutes in both eyes] with symptoms (dryness, eye discomfort, or visual fatigue, ≥30 [0-100]) despite treatment with at least one prescription drop and deemed candidate for topical steroid.

Methods: Seventy-five adult patients were enrolled. A 1:1 randomization sequence was used to determine which eye of each patient would receive the treatment (dexamethasone 0.4 mg intracanalicular insert with 30-day elution time) or the sham (collagen plug). The fellow eye received the opposite treatment. Patients were masked to treatment assignment. Follow-up visits (at weeks 2, 4, and 6) were performed by a masked investigator.

Main outcome measures: Dry eye parameters and patient symptoms were used for efficacy and intraocular pressure (IOP) was used for safety assessment.

Results: The severity of dry eye was comparable between the treatment arms (fellow eyes) at baseline. Eyes that received the dexamethasone insert had significantly less corneal staining at week 4 (mean difference [MD] -0.55, 95% confidence interval [CI] = -0.91, -0.19) and conjunctival staining at week 4 (MD -0.68, 95% CI = -1.05, -0.30) and week 6 (MD -0.34, 95% CI = -0.65, -0.02). Schirmer's wetting was comparable between the two treatment arms. Although the patients reported less dryness in eyes that received the insert at week 4 (MD -5.5, 95% CI = -11.4, 0.4), there were no statistically significant differences in any patient-reported symptoms. At week 4, dexamethasone-treated eyes were more likely to experience an IOP increase (by 5-10 mm Hg) (9 eyes vs. 1 eye; relative risk [RR] = 9.00, 95% CI = 1.14, 71.0; due to sparse events, the CI was very wide). All cases of increased IOP were managed with short-term topical beta blockers and subsided.

Conclusions: Dexamethasone intracanalicular insert may be considered a dropless dual treatment for clinically significant aqueous-deficient dry eye when topical steroid treatment is deemed appropriate.

Keywords: Dry eye; clinical trial; treatment.