Safety, Tolerability, Plug Retention and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B

Summary

The purpose of this interventional study is to assess safety, patient tolerability, plug retention rate, and preliminary efficacy in improving the symptoms of Dry Eye Disease (DED) of EXP-TC tacrolimus releasing punctal plug. The main questions it aims to answer are: 1. The safety of using EXP-TC plug following all study adverse events 2. The number of patients with Adverse Events related to the us of EXP-LP plug 3. The number of patients discontinuing the study due to plug discomfort 4. The total patients with plugs remained during the 3-months study duration from plug insertion 5. Exploratory: change from baseline in the study eye to follow-up visits in various Dryness clinical measurements. The change of measurements from baseline will also be compared between the study and fellow control eye (receiving artificial tears only, 0.15% sodium hyaluronate).

Timeline

Start

2022-09-29

Primary completion

2023-12-30

Completion

2023-12-30

Publications

• Background Baldo A, Cafiero M, Di Caterino P, Di Costanzo L. Tacrolimus ointment in the management of atopic dermatitis. Clin Cosmet Investig Dermatol. 2009 Jan 27;2:1-7. doi: 10.2147/ccid.s3378.
• Background Berdoulay A, English RV, Nadelstein B. Effect of topical 0.02% tacrolimus aqueous suspension on tear production in dogs with keratoconjunctivitis sicca. Vet Ophthalmol. 2005 Jul-Aug;8(4):225-32. doi: 10.1111/j.1463-5224.2005.00390.x.
• Background Ebihara N, Ohashi Y, Fujishima H, Fukushima A, Nakagawa Y, Namba K, Okamoto S, Shoji J, Takamura E, Uchio E, Miyazaki D. Blood level of tacrolimus in patients with severe allergic conjunctivitis treated by 0.1% tacrolimus ophthalmic suspension. Allergol Int. 2012 Jun;61(2):275-82. doi: 10.2332/allergolint.11-OA-0349. Epub 2012 Feb 25.
• Results Fukushima A, Ohashi Y, Ebihara N, Uchio E, Okamoto S, Kumagai N, Shoji J, Takamura E, Nakagawa Y, Namba K, Fujishima H, Miyazaki D. Therapeutic effects of 0.1% tacrolimus eye drops for refractory allergic ocular diseases with proliferative lesion or corneal involvement. Br J Ophthalmol. 2014 Aug;98(8):1023-7. doi: 10.1136/bjophthalmol-2013-304453. Epub 2014 Apr 2.
• Results Haddad EM, McAlister VC, Renouf E, Malthaner R, Kjaer MS, Gluud LL. Cyclosporin versus tacrolimus for liver transplanted patients. Cochrane Database Syst Rev. 2006 Oct 18;2006(4):CD005161. doi: 10.1002/14651858.CD005161.pub2.
• Results Hanifin JM, Paller AS, Eichenfield L, Clark RA, Korman N, Weinstein G, Caro I, Jaracz E, Rico MJ; US Tacrolimus Ointment Study Group. Efficacy and safety of tacrolimus ointment treatment for up to 4 years in patients with atopic dermatitis. J Am Acad Dermatol. 2005 Aug;53(2 Suppl 2):S186-94. doi: 10.1016/j.jaad.2005.04.062.
• Results Kanellopoulos AJ, Asimellis G. In pursuit of objective dry eye screening clinical techniques. Eye Vis (Lond). 2016 Jan 18;3:1. doi: 10.1186/s40662-015-0032-4. eCollection 2016.
• Results Moscovici BK, Holzchuh R, Chiacchio BB, Santo RM, Shimazaki J, Hida RY. Clinical treatment of dry eye using 0.03% tacrolimus eye drops. Cornea. 2012 Aug;31(8):945-9. doi: 10.1097/ICO.0b013e31823f8c9b.
• Results Reitamo S, Ortonne JP, Sand C, Cambazard F, Bieber T, Folster-Holst R, Vena G, Bos JD, Fabbri P, Groenhoej Larsen C; European Tacrolimus Ointment Study Group. A multicentre, randomized, double-blind, controlled study of long-term treatment with 0.1% tacrolimus ointment in adults with moderate to severe atopic dermatitis. Br J Dermatol. 2005 Jun;152(6):1282-9. doi: 10.1111/j.1365-2133.2005.06592.x.

Drugs

Indications