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

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.