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Secondary outcomes from a phase 4 open-label study investigating signs and symptoms of ocular surface disease in patients switching from bimatoprost 0.03% + timolol 0.5% to tafluprost 0.0015% + timolol 0.5% eye drops

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Session Details

Session Title: Presented Poster Session: Glaucoma

Venue: Poster Village: Pod 2

First Author: : R.Bourne UK

Co Author(s): :    C. Traverso   K. Lorenz   K. Kaarniranta   A. Ropo     

Abstract Details

Purpose:

Bimatoprost 0.03% + timolol 0.5% and tafluprost 0.0015% + timolol 0.5% eye drops are currently the only topical intraocular pressure (IOP)-reducing therapies available as preservative-free (PF) prostaglandin and timolol fixed-dose combination (FDC). This study investigated ocular signs and symptoms when patients with ocular hypertension (OH) or open-angle glaucoma (OAG) switched from PF or preserved bimatoprost 0.03% + timolol 0.5% to PF tafluprost 0.0015% + timolol 0.5% eye drops. Primary outcomes of signs and symptoms of ocular surface disease have been presented previously; secondary outcomes, including 12-week changes from screening in the remaining ocular symptoms and signs, are presented here.

Setting:

This study was conducted at 16 centres in Finland, Germany, Italy and the UK

Methods:

This 12-week, open-label, phase 4 study (EudraCT 2014-005273-37) enrolled patients with OH or OAG (IOP ≤21 mmHg on medication) treated with PF or preserved bimatoprost 0.03% + timolol 0.5% eye drops for ≥4 weeks before screening. Patients were switched to PF tafluprost 0.0015% + timolol 0.5% eye drops once daily in the treated eye(s). Ocular symptoms were graded by the patients using a 5-point scale. Symptom score <2 was defined as normal and ≥2 as abnormal. Tear break-up time (TBUT), an ocular sign, was also assessed; a TBUT <10 seconds was considered abnormal.

Results:

Of 123 patients enrolled, 121 were included in the intention-to-treat dataset; 76 patients used BAK-preserved bimatoprost 0.03% + timolol 0.5% and 45 used PF drops. At screening, the proportions of patients with an abnormal ocular symptom ranged from 46.3% (tearing) to 71.9% (irritation/burning/stinging). Reduced prevalence of abnormal symptoms was observed at 2 weeks (tearing: 26.4%, irritation/burning/stinging: 39.7%); at 12 weeks, the respective proportions were 20.2% and 34.2%. In addition, 71% of patients had reduced irritation/burning/stinging symptom severity at 12 weeks. The mean TBUT increased in BAK-preserved and PF subgroups. This improvement was observed from 2 to 12 weeks (p<0.001).

Conclusions:

PF tafluprost 0.0015% + timolol 0.5% reduced the prevalence of abnormal symptoms in patients that had received bimatoprost 0.03% + timolol 0.5%; this change was observed as early as 2 weeks and was sustained for 12 weeks. The beneficial effects of tafluprost 0.0015% + timolol 0.5% were also reflected in the TBUT measurements, an indicator of dry eye. Overall, switching from bimatoprost 0.03% + timolol 0.5% to tafluprost 0.0015% + timolol 0.5% eye drops resulted in reductions in signs and symptoms of ocular surface disease regardless of patients’ prior use of preserved or PF bimatoprost 0.03% + timolol 0.5%.

Financial Disclosure:

is employed by a for-profit company with an interest in the subject of the presentation, travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, research is funded, fully or partially, by a competing company, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, receives consulting fees, retainer, or contract payments from a competing company, receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented

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