{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,18]],"date-time":"2026-04-18T01:51:56Z","timestamp":1776477116183,"version":"3.51.2"},"reference-count":26,"publisher":"BMJ","issue":"4","license":[{"start":{"date-parts":[[2025,10,14]],"date-time":"2025-10-14T00:00:00Z","timestamp":1760400000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100032752","name":"Laboratoires Th\u00e9a","doi-asserted-by":"crossref","award":["No specific grant or award number is associated wi"],"award-info":[{"award-number":["No specific grant or award number is associated wi"]}],"id":[{"id":"10.13039\/100032752","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Br J Ophthalmol"],"accepted":{"date-parts":[[2025,10,1]]},"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:sec>\n                    <jats:title>Background\/Aims<\/jats:title>\n                    <jats:p>To compare the efficacy and safety of a new preservative-free bimatoprost 0.01%\/timolol 0.1% fixed combination (BTFC) eye gel with those of bimatoprost 0.03%\/timolol 0.5% fixed combination ophthalmic solution (BTFC eye drops) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this phase III, international, multi-centre, randomised, parallel group, investigator-masked study, patients receiving a first-line monotherapy, having insufficiently controlled intraocular pressure (IOP) and requiring dual therapy were randomised to receive either BTFC eye gel or BTFC eye drops once daily for 12 weeks. The primary efficacy endpoint was the change in IOP from baseline to week 12 at 08:00 in the assessed eye. Further efficacy and safety endpoints were assessed as secondary outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The mean\u00b1SD change in IOP from baseline to week 12 at 08:00 was \u221210.96\u00b13.43\u2009mmHg for the BTFC eye gel group and \u221211.14\u00b13.56\u2009mmHg for the BTFC eye drop group. The least-squares mean difference (BTFC eye gel minus BTFC eye drops) was \u22120.04\u00b10.24\u2009mmHg (95%\u2009CI \u22120.51 to 0.43\u2009mmHg), with the upper bound of the 95%\u2009CI lower than the predefined margin of +1.5\u2009mmHg at week 12 at 08:00. Similar IOP-lowering efficacy was demonstrated at all other timepoints. The safety profile was comparable between the treatment groups. No patients in the BTFC eye gel group discontinued the study due to a treatment-related adverse event compared with 8 (2.9%) patients in the BTFC eye drop group.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Low-concentration BTFC eye gel can be considered as a safe and effective treatment in the therapeutic management of glaucoma and OHT.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bjo-2025-327555","type":"journal-article","created":{"date-parts":[[2025,10,15]],"date-time":"2025-10-15T08:00:15Z","timestamp":1760515215000},"page":"403-409","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Low-concentration bimatoprost 0.01% and timolol 0.1% eye gel versus bimatoprost 0.03% and timolol 0.5% eye drops in open-angle glaucoma or ocular hypertension: a phase III randomised study"],"prefix":"10.1136","volume":"110","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8663-6525","authenticated-orcid":false,"given":"M Francesca","family":"Cordeiro","sequence":"first","affiliation":[{"name":"Imperial College Ophthalmic Research Group (ICORG), Imperial College London, London, England, UK"},{"name":"Glaucoma & Retinal Neurodegeneration Research Group, University College London, London, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesco","family":"Oddone","sequence":"additional","affiliation":[{"name":"Clinical and Research Institute of Ophthalmology, IRCCS Fondazione G.B.Bietti, Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1134-520X","authenticated-orcid":false,"given":"Elena Atanasova","family":"Mermeklieva","sequence":"additional","affiliation":[{"name":"MC \u201cOphtha-Neuro\u201d Medical Faculty, Sofia University St Kliment Ohridski, Sofia, Sofia City Province, Bulgaria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dariusz MD","family":"Rokicki","sequence":"additional","affiliation":[{"name":"Laboratoires Thea, Clermont-Ferrand, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sylvie","family":"Nissl\u00e9","sequence":"additional","affiliation":[{"name":"Laboratoires Thea, Clermont-Ferrand, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Piotr","family":"Go\u015bciniewicz","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, WSB University, Dabrowa Gornicza, Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ingeborg","family":"Stalmans","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, University Hospitals Leuven, Leuven, Flanders, Belgium"},{"name":"Research Group Ophthalmology, KU Leuven Department of Neurosciences, Leuven, Flanders, Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2025,10,14]]},"reference":[{"key":"2026032002151784000_110.4.403.1","first-page":"618","article-title":"Updates on the Diagnosis and Management of Glaucoma","volume":"6","author":"Wagner","year":"2022","journal-title":"Mayo Clinic Proceedings: Innovations, Quality & Outcomes"},{"key":"2026032002151784000_110.4.403.2","doi-asserted-by":"crossref","DOI":"10.1155\/2020\/6138132","article-title":"Current Medical Therapy and Future Trends in the Management of Glaucoma Treatment","volume":"2020","author":"Cvenkel","year":"2020","journal-title":"J Ophthalmol"},{"key":"2026032002151784000_110.4.403.3","doi-asserted-by":"crossref","first-page":"809","DOI":"10.1007\/s004170100328","article-title":"Ocular surface changes induced by topical application of latanoprost and timolol: a short-term study in glaucomatous patients with and without allergic conjunctivitis","volume":"239","author":"Costagliola","year":"2001","journal-title":"Graefes Arch Clin Exp Ophthalmol"},{"key":"2026032002151784000_110.4.403.4","unstructured":"European Glaucoma Society . Terminology and guidelines for glaucoma. 4th edn. Savona, Italy, 2014."},{"key":"2026032002151784000_110.4.403.5","doi-asserted-by":"crossref","first-page":"53","DOI":"10.1177\/112067210701700108","article-title":"A double-masked, randomized, parallel comparison of a fixed combination of bimatoprost 0.03%\/timolol 0.5% with non-fixed combination use in patients with glaucoma or ocular hypertension","volume":"17","author":"Hommer","year":"2007","journal-title":"Eur J Ophthalmol"},{"key":"2026032002151784000_110.4.403.6","doi-asserted-by":"publisher","DOI":"10.1097\/IJG.0b013e3181507313"},{"key":"2026032002151784000_110.4.403.7","doi-asserted-by":"publisher","DOI":"10.1097\/IJG.0b013e3181bdb586"},{"key":"2026032002151784000_110.4.403.8","doi-asserted-by":"crossref","first-page":"659","DOI":"10.1016\/S0181-5512(08)74379-1","article-title":"Satisfaction and compliance of ocular hypertensive and glaucoma patients topically treated with a combination therapy","volume":"31","author":"Bron","year":"2008","journal-title":"J Fr Ophtalmol"},{"key":"2026032002151784000_110.4.403.9","doi-asserted-by":"publisher","DOI":"10.5301\/ejo.5000004"},{"key":"2026032002151784000_110.4.403.10","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajo.2009.12.003"},{"key":"2026032002151784000_110.4.403.11","doi-asserted-by":"crossref","DOI":"10.1155\/2015\/567387","article-title":"Association between Ophthalmic Timolol and Hospitalisation for Bradycardia","volume":"2015","author":"Pratt","year":"2015","journal-title":"J Ophthalmol"},{"key":"2026032002151784000_110.4.403.12","doi-asserted-by":"crossref","DOI":"10.3390\/polym10111221","article-title":"Strategies for Improving Ocular Drug Bioavailability and Corneal Wound Healing with Chitosan-Based Delivery Systems","volume":"10","author":"Irimia","year":"2018","journal-title":"Polymers (Basel)"},{"key":"2026032002151784000_110.4.403.13","doi-asserted-by":"crossref","first-page":"28","DOI":"10.5301\/ejo.5000006","article-title":"Timogel\u00ae vs timolol 0.5% ophthalmic solution: efficacy, safety, and acceptance","volume":"22","author":"Rolle","year":"2012","journal-title":"Eur J Ophthalmol"},{"key":"2026032002151784000_110.4.403.14","doi-asserted-by":"publisher","DOI":"10.1177\/0091270011420254"},{"key":"2026032002151784000_110.4.403.15","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0420.2005.00562.x"},{"key":"2026032002151784000_110.4.403.16","doi-asserted-by":"crossref","first-page":"422","DOI":"10.1097\/IJG.0000000000002371","article-title":"Preservative-Free Bimatoprost 0.01% Ophthalmic Gel for Glaucoma Therapy: A Phase III Randomized Controlled Trial","volume":"33","author":"Mu\u00f1oz-Negrete","year":"2024","journal-title":"J Glaucoma"},{"key":"2026032002151784000_110.4.403.17","doi-asserted-by":"crossref","first-page":"643","DOI":"10.2147\/OPTH.S59197","article-title":"Bimatoprost 0.01% or 0.03% in patients with glaucoma or ocular hypertension previously treated with latanoprost: two randomized 12-week trials","volume":"8","author":"Myers","year":"2014","journal-title":"OPTH"},{"key":"2026032002151784000_110.4.403.18","doi-asserted-by":"crossref","first-page":"775","DOI":"10.1080\/03007995.2023.2197496","article-title":"A randomized clinical trial comparing three fixed combinations of bimatoprost with timolol in patients with open-angle glaucoma or ocular hypertension","volume":"39","author":"Mrukwa-Kominek","year":"2023","journal-title":"Curr Med Res Opin"},{"key":"2026032002151784000_110.4.403.19","unstructured":"Hodapp E , Parrish RK , Anderson DR . Clinical decisions in glaucoma. 1993. Available: https:\/\/books.google.fr\/books\/about\/Clinical_Decisions_in_Glaucoma.html?id=DZJsAAAAMAAJ&redir_esc=y"},{"key":"2026032002151784000_110.4.403.20","doi-asserted-by":"publisher","DOI":"10.1136\/bjophthalmol-2011-301266"},{"key":"2026032002151784000_110.4.403.21","doi-asserted-by":"crossref","first-page":"100135","DOI":"10.1016\/j.ajoint.2025.100135","article-title":"Intracameral prostaglandin implant vs Timolol in open-angle glaucoma or ocular hypertension: a systematic review and meta-analysis","volume":"2","author":"Sharma","year":"2025","journal-title":"AJO International"},{"key":"2026032002151784000_110.4.403.22","doi-asserted-by":"publisher","DOI":"10.1159\/000067548"},{"key":"2026032002151784000_110.4.403.23","doi-asserted-by":"crossref","first-page":"8","DOI":"10.1089\/jop.2024.0092","article-title":"Preclinical and Clinical Pharmacokinetics of a New Preservative-Free Bimatoprost 0.01% Ophthalmic Gel to Treat Glaucoma and Ocular Hypertension","volume":"41","author":"Erb","year":"2025","journal-title":"J Ocul Pharmacol Ther"},{"key":"2026032002151784000_110.4.403.24","doi-asserted-by":"crossref","first-page":"113","DOI":"10.1016\/j.addr.2017.12.017","article-title":"Ophthalmic gels: Past, present and future","volume":"126","author":"Al-Kinani","year":"2018","journal-title":"Adv Drug Deliv Rev"},{"key":"2026032002151784000_110.4.403.25","doi-asserted-by":"publisher","DOI":"10.1136\/bjo.82.10.1131"},{"key":"2026032002151784000_110.4.403.26","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1007\/BF02850114","article-title":"Multicenter, open-label evaluation of hyperemia associated with use of bimatoprost in adults with open-angle glaucoma or ocular hypertension","volume":"20","author":"Abelson","year":"2003","journal-title":"Adv Ther"}],"container-title":["British Journal of Ophthalmology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bjo-2025-327555","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,20]],"date-time":"2026-03-20T09:16:08Z","timestamp":1773998168000},"score":1,"resource":{"primary":{"URL":"https:\/\/bjo.bmj.com\/lookup\/doi\/10.1136\/bjo-2025-327555"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,14]]},"references-count":26,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2026,3,20]]},"published-print":{"date-parts":[[2026,4]]}},"alternative-id":["10.1136\/bjo-2025-327555"],"URL":"https:\/\/doi.org\/10.1136\/bjo-2025-327555","relation":{},"ISSN":["0007-1161","1468-2079"],"issn-type":[{"value":"0007-1161","type":"print"},{"value":"1468-2079","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,14]]}}}