Latanoprost Eluting Contact Lens for Treating Glaucoma and Ocular Hypertension

Summary

In this research study, we will assess the safety, tolerability, comfort, and feasibility of lowering intraocular pressure using a novel Contact Lens Drug Delivery System with latanoprost. Latanoprost is a well-studied medication and has been used to treat glaucoma for decades. Currently, latanoprost is FDA-approved to be administered to patients as eye drops, but using eye drops has challenges (having to remember to take the drop, getting the drop in the eye). This clinical trial is being done to determine the safety, tolerability, and effectiveness of using latanoprost to deliver latanoprost in a new way (through a drug-eluting contact lens). The study includes two phases. Phase A is intended to assess safety and tolerability and Phase B to assess safety and effectiveness.

Timeline

Start

2024-04-03

Primary completion

2025-10-10

Completion

2025-10-10

Publications

• Background Ciolino JB, Ross AE, Tulsan R, Watts AC, Wang RF, Zurakowski D, Serle JB, Kohane DS. Latanoprost-Eluting Contact Lenses in Glaucomatous Monkeys. Ophthalmology. 2016 Oct;123(10):2085-92. doi: 10.1016/j.ophtha.2016.06.038. Epub 2016 Aug 29.
• Background Ciolino JB, Stefanescu CF, Ross AE, Salvador-Culla B, Cortez P, Ford EM, Wymbs KA, Sprague SL, Mascoop DR, Rudina SS, Trauger SA, Cade F, Kohane DS. In vivo performance of a drug-eluting contact lens to treat glaucoma for a month. Biomaterials. 2014 Jan;35(1):432-9. doi: 10.1016/j.biomaterials.2013.09.032. Epub 2013 Oct 4.
• Background Friedman DS, Wolfs RC, O'Colmain BJ, Klein BE, Taylor HR, West S, Leske MC, Mitchell P, Congdon N, Kempen J; Eye Diseases Prevalence Research Group. Prevalence of open-angle glaucoma among adults in the United States. Arch Ophthalmol. 2004 Apr;122(4):532-8. doi: 10.1001/archopht.122.4.532.
• Background Sleath B, Blalock S, Covert D, Stone JL, Skinner AC, Muir K, Robin AL. The relationship between glaucoma medication adherence, eye drop technique, and visual field defect severity. Ophthalmology. 2011 Dec;118(12):2398-402. doi: 10.1016/j.ophtha.2011.05.013.

Drugs

Indications