drugset / Trial / NCT05213156
Concentration of Ofloxacin Into the Aqueous Humour of Patients With Dry Eye Disease
RandomizedFactorialQuadruple-blindScreening
Summary
After topical installation of one drop of 0.3% commercially available ofloxacin (Oxatrex®) four times at intervals of 15min in catarract patients with Dry Eye Disease, aqueous humour samples will be collected intraoperatively, one hour after the last installation. Concentration of ofloxacin in aqueous humour will be measured by HPLC-MS/MS.
Timeline
- Start
- 2019-09-24
- Primary completion
- 2022-01-24
- Completion
- 2022-01-24
Publications
- Background Baudouin C, Aragona P, Van Setten G, Rolando M, Irkec M, Benitez del Castillo J, Geerling G, Labetoulle M, Bonini S; ODISSEY European Consensus Group members. Diagnosing the severity of dry eye: a clear and practical algorithm. Br J Ophthalmol. 2014 Sep;98(9):1168-76. doi: 10.1136/bjophthalmol-2013-304619. Epub 2014 Mar 13.
- Background Perez VL, Stern ME, Pflugfelder SC. Inflammatory basis for dry eye disease flares. Exp Eye Res. 2020 Dec;201:108294. doi: 10.1016/j.exer.2020.108294. Epub 2020 Oct 8.
- Background Agrahari V, Mandal A, Agrahari V, Trinh HM, Joseph M, Ray A, Hadji H, Mitra R, Pal D, Mitra AK. A comprehensive insight on ocular pharmacokinetics. Drug Deliv Transl Res. 2016 Dec;6(6):735-754. doi: 10.1007/s13346-016-0339-2.
- Background Barar J, Javadzadeh AR, Omidi Y. Ocular novel drug delivery: impacts of membranes and barriers. Expert Opin Drug Deliv. 2008 May;5(5):567-81. doi: 10.1517/17425247.5.5.567.
- Background Gatti G, Panozzo G. Effect of inflammation on intraocular penetration of intravenous ofloxacin in albino rabbits. Antimicrob Agents Chemother. 1995 Feb;39(2):549-52. doi: 10.1128/AAC.39.2.549.
- Background Ozturk F, Kortunay S, Kurt E, Inan UU, Ilker SS, Basci N, Bozkurt A. The effect of long-term use and inflammation on the ocular penetration of topical ofloxacin. Curr Eye Res. 1999 Dec;19(6):461-4. doi: 10.1076/ceyr.19.6.461.5277.
- Background Ozturk F, Kurt E, Inan UU, Kortunay MC, Ilker SS, Basci NE, Bozkurt A. Penetration of topical and oral ofloxacin into the aqueous and vitreous humor of inflamed rabbit eyes. Int J Pharm. 2000 Aug 25;204(1-2):91-5. doi: 10.1016/s0378-5173(00)00482-8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ofloxacin | Small molecule | 0.3 % | Topical |