Abstract | PURPOSE: DESIGN: Multicenter, randomized, double-masked, placebo-controlled, Phase 3 clinical trial. METHODS: Subjects with allergic conjunctivitis were randomized 1:1 to receive a dexamethasone insert or a placebo insert in both eyes and were evaluated using a modified version of the conjunctival allergen challenge (CAC) model. After inserts were placed in office, a series of 4 closely spaced post-insertion CACs were conducted at weeks 1, 2, and 4 across approximately 30 days. Primary efficacy endpoints, assessed at week-1 CAC-day 8, were reported by subjects of ocular itching at 3, 5, and 7 minutes post CAC and investigator-evaluated conjunctival redness at 7, 15, and 20 minutes post CAC. RESULTS: For the primary endpoints, dexamethasone inserts showed statistically significantly lower mean ocular itching scores than placebo at all time points (P <.001), with differences favoring dexamethasone inserts over placebo (0.86, 0.98, and 0.96 units at 3, 5, and 7 minutes, respectively) and statistically significantly lower conjunctival redness scores at 20 minutes (P <.05) but not at 7 or 15 minutes (P ≥.05). Results also showed statistically significantly less itching and conjunctival redness at 31 and 29 of 33 other time points, respectively (P <.05). There were no serious adverse events; 1 subject had elevated intraocular pressure in both eyes. CONCLUSIONS: Data presented in this study demonstrate the potential for a single, physician-administered dexamethasone intracanalicular insert to provide relief of ocular itching for up to 4 weeks in subjects with allergic conjunctivitis, while maintaining a favorable safety profile.
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Authors | Eugene B McLaurin, David Evans, Carolyn S Repke, Michelle A Sato, Paul J Gomes, Erin Reilly, Nysha Blender, Fabiana Q Silva, Srilatha Vantipalli, Jamie L Metzinger, Andrea Gibson, Michael H Goldstein |
Journal | American journal of ophthalmology
(Am J Ophthalmol)
Vol. 229
Pg. 288-300
(09 2021)
ISSN: 1879-1891 [Electronic] United States |
PMID | 33773984
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Allergens
- Anti-Allergic Agents
- Ophthalmic Solutions
- Dexamethasone
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Topics |
- Allergens
(therapeutic use)
- Anti-Allergic Agents
- Conjunctivitis, Allergic
(diagnosis, drug therapy)
- Dexamethasone
(therapeutic use)
- Double-Blind Method
- Humans
- Ophthalmic Solutions
(therapeutic use)
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