Comparison of the Postoperative Use of Dextenza vs a Standard Regimen After PRK
Summary
Naval Refractive Surgery Center proposes a prospective, single-site, randomized, non-FDA regulated clinical trial with bilateral commercial treatment for for PRK. Subjects will be randomized to receive one of two postoperative steroid regimens: Dextenza (a dexamethasone ophthalmic insert) or standard of care topical Fluorometholone. Subjects will be followed for 3 months after surgery. Investigators will use objective and subjective measures to assess potential differences in postoperative healing and pain. This study will not be FDA-regulated. All study surgeries will be standard of care, with the exception of the addition of the Dextenza insert after the PRK procedure among subjects randomized to the Dextenza group.
Timeline
- Start
- 2022-10
- Primary completion
- 2024-10
- Completion
- 2024-10
Publications
- Background Lee A, Blair HA. Dexamethasone Intracanalicular Insert: A Review in Treating Post-Surgical Ocular Pain and Inflammation. Drugs. 2020 Jul;80(11):1101-1108. doi: 10.1007/s40265-020-01344-6.
- Background Brooks CC, Jabbehdari S, Gupta PK. Dexamethasone 0.4mg Sustained-Release Intracanalicular Insert in the Management of Ocular Inflammation and Pain Following Ophthalmic Surgery: Design, Development and Place in Therapy. Clin Ophthalmol. 2020 Jan 13;14:89-94. doi: 10.2147/OPTH.S238756. eCollection 2020.
- Background Tyson SL, Campbell P, Biggins J, Driscoll A, Jarrett P, Gibson A, Vantipalli S, Metzinger JL, Goldstein MH. Punctum and canalicular anatomy for hydrogel-based intracanalicular insert technology. Ther Deliv. 2020 Mar;11(3):173-182. doi: 10.4155/tde-2020-0010. Epub 2020 Mar 16.
- Background Cheng KJ, Hsieh CM, Nepali K, Liou JP. Ocular Disease Therapeutics: Design and Delivery of Drugs for Diseases of the Eye. J Med Chem. 2020 Oct 8;63(19):10533-10593. doi: 10.1021/acs.jmedchem.9b01033. Epub 2020 Jun 2.
- Background McLaurin EB, Evans D, Repke CS, Sato MA, Gomes PJ, Reilly E, Blender N, Silva FQ, Vantipalli S, Metzinger JL, Gibson A, Goldstein MH. Phase 3 Randomized Study of Efficacy and Safety of a Dexamethasone Intracanalicular Insert in Patients With Allergic Conjunctivitis. Am J Ophthalmol. 2021 Sep;229:288-300. doi: 10.1016/j.ajo.2021.03.017. Epub 2021 Mar 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 0.4 mg | Other |
| Comparator | Fluorometholone | Other / unclassified | 0.1 % | Topical |
Indications
No indication recorded.