Effects of Punctal Occlusion on Ocular Itching and Conjunctival Redness Associated with Allergic Conjunctivitis

Abstract

Purpose

Punctal occlusion using punctal plugs has been successfully used to treat the signs and symptoms of dry eye disease. However, the effects of punctal occlusion on the symptoms of allergic conjunctivitis (AC) have been less well documented. There is some concern among clinicians that punctal occlusion may make signs/symptoms of allergic conjunctivitis worse by trapping allergens on the eye. The objective of this post hoc analysis was to address this question and thus assess the effect of punctal occlusion alone on ocular itching and conjunctival redness associated with AC.

Methods

This was a pooled post hoc analysis of three randomized, double-blind, placebo insert-controlled clinical trials in subjects with AC. Enrolled subjects were generally healthy adults with ocular allergies and a positive skin test reaction to perennial and/or seasonal allergens. The study used a modified version of the traditional conjunctival allergen challenge (CAC) model, which included multiple, repeated allergen challenges following placement of the intracanalicular insert. Subjects were rechallenged on Days 6, 7 and 8; Days 13, 14 and 15; and Days 26, 27 and 28.

Results

The data set included 128 subjects that were administered placebo. Baseline mean (SD) ocular itching and conjunctival redness scores were 3.52 (0.44) and 2.97 (0.39), respectively. On post-insertion Days 7, 14 and 28, mean itching scores were 2.62, 2.26 and 1.91, respectively, representing 26%, 36% and 46% itching reductions, respectively (p < 0.001). On Days 7, 14 and 28, mean conjunctival redness scores were 1.98, 1.90, and 2.08, respectively, representing 33%, 36%, and 30% redness reductions, respectively (p < 0.001).

Conclusions

Based on this post hoc pooled analysis, punctal occlusion with a resorbable hydrogel intracanalicular insert did not worsen ocular itching or conjunctival redness in this patient population.

Keywords:

• Allergic conjunctivitis
• punctal occlusion
• intracanalicular insert
• pooled analysis
• post hoc analysis

Acknowledgements

The authors acknowledge the editorial assistance of Dr. Carl S. Hornfeldt, Apothekon, Inc., during the preparation of this manuscript.

Disclosure statement

Steven M. Silverstein was a study investigator and reports grants from Ocular Therapeutix, Inc. Michelle A. Sato, and Edward J. Meier were study investigators and have no conflicts of interest to disclose. Stella Dai, Aditi Bauskar, Kennedy Depperschmidt, Nysha Blender, Srilatha Vantipalli, and Rabia Gurses Ozden are employees of Ocular Therapeutix, Inc. Michael H. Goldstein is a consultant for and former employee of Ocular Therapeutix, Inc.

Data availability statement

Data sharing is not applicable to this article as no new data were created or analyzed in this study.

Additional information

Funding

This study was sponsored by Ocular Therapeutix, Inc., Bedford, MA.