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Jason Bacharach,1 Iqbal Ike K Ahmed,2 Elizabeth D Sharpe,3 Michael S Korenfeld,4 Steven Zhang,5 Christophe Baudouin6 1North Bay Eye Associates, Sonoma County, CA, USA; 2John Moran Eye Center, University of Utah, Salt Lake City, UT, USA; 3Glaucoma Consultants and Center for Eye Research, Mt. Pleasant, SC, USA; 4Comprehensive Eye Care, Washington, MO, USA; 5Thea Pharma, Inc, Lexington, MA, USA; 6Quinze-Vingts National Ophthalmology Hospital & Vision Institute, Paris Saclay-Versailles-Saint Quentin University, IHU Foresight, Paris, FranceCorrespondence: Jason Bacharach, Email jbacharach@northbayeye.comPurpose: To evaluate the safety and efficacy of a preservative-free latanoprost 0.005% formulation (T2345) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) compared to benzalkonium chloride–preserved latanoprost 0.005% (BPL) formulation in the United States (US).Patients and Methods: A prospective, randomized, multicenter, observer-masked, parallel-group study enrolled 335 patients diagnosed with POAG or OHT from 31 US sites who had adequately controlled intraocular pressure (IOP; ≤ 18 mm Hg) with latanoprost monotherapy. After a ≥ 72-hour washout period, patients were randomized to T2345 (n=165) or BPL (n=170) groups. Study drugs were dosed once-daily from Day 0 to Day 84 in one or both eyes. The study eye was the eye with lower IOP at baseline. The primary efficacy measure was the between-group comparison of the mean IOP values in the study eye at each time point (8 AM, 10 AM, and 4 PM on Days 15, 42, and 84). Safety measurements included ocular and systemic treatment-emergent adverse events (TEAEs).Results: Both T2345 and BPL adequately controlled IOP with 95% CIs within 1.5 mm Hg in the study eye at all assessed time points. The percentages of patients with diurnal IOP < 18 mm Hg at Day 84 were 73.1% vs 78.7% for the T2345 and BPL groups, respectively. Adverse events were generally mild-to-moderate and primarily ocular. Fewer patients in the T2345 group experienced ocular TEAEs (13.9% vs 22.5%, respectively) and TEAEs with a suspected relationship to the study medication compared with the BPL group (5.5% vs 11.8%, respectively). The most common ocular TEAEs were instillation site pain and conjunctival hyperemia.Conclusion: In patients with POAG or OHT, both T2345 and BPL maintained IOP at or below clinically meaningful values for the duration of the study. T2345 showed a favorable safety profile, with numerically lower incidences of ocular TEAEs than BPL.Keywords: glaucoma, ocular hypertension, intraocular pressure, benzalkonium chloride, latanoprost, preservative

Ingeborg Stalmans,1 Hans Lemij,2 Jonathan Clarke,3 Christophe Baudouin4 On behalf of the GOAL study group1Department of Ophthalmology, UZ Leuven, Leuven, Belgium; 2Glaucoma Service, Rotterdam Eye Hospital, Rotterdam, the Netherlands; 3NIHR Biomedical Research Centre - Moorfields Eye Hospital, NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK; 4Ophthalmology Unit, Quinze-Vingts National Hospital and Vision Institute, IHU ForeSight, Sorbonne University, Paris, FranceCorrespondence: Christophe BaudouinOphthalmology Unit, Quinze-Vingts National Hospital and Vision Institute, IHU ForeSight, Sorbonne University, Paris, FranceEmail cbaudouin@15-20.frAbstract: Ocular Surface Disease (OSD) and hyperemia are the most common adverse events of topical ocular medications. While active compounds may cause allergic reactions or irritation, preservatives, which are intended to prevent bacterial growth, are toxic as well. Therefore, the most recent glaucoma medications no longer contain preservatives. Despite this, local tolerability may still impact treatment compliance and patient quality of life. We conducted an observational, multi-center, international, cross-sectional study in 793 treated and stabilized glaucoma patients to assess patient satisfaction and local tolerability of their treatment. The vast majority (93.7%) of patients was satisfied or very satisfied with their treatment in terms of tolerability and only 6.3% were dissatisfied. However, ophthalmological examination showed a high frequency of ocular signs: conjunctival hyperemia (32%), OSD (42.5%) and positive conjunctival fluorescein staining (10.3%). Additionally, patients reported symptoms upon instillation (31.4%) and between instillations (57.3%); 25.1% of patients were using tear substitutes. All signs and symptoms were significantly (p< 0.001) associated with patient dissatisfaction. A logistic regression model indicated that dissatisfaction was higher in patients with symptoms upon instillation and in those using tear substitutes (OR: 3.03 and 4.63, respectively). The mean patient tolerability score to treatment was 82.7± 16.1 on a 100-point visual analogue scale. In conclusion, even if patients may be highly satisfied with their current treatment, most of them present ocular signs and symptoms. A treatment change should be considered in case of clinical signs or patient-reported symptoms.Keywords: glaucoma, tolerance, preservatives, tear substitutes, patient satisfaction, ocular surface disease