Comparison of the Toxicity Profile of Benzalkonium Chloride-Preserved Tafluprost and SofZia-Preserved Travoprost Applied to the Ocular Surface

BackgroundThe aim of this work is to evaluate efficacy and tolerability of preservative containing 0.0015% tafluprost and preservative-free 0.0015% tafluprost using a prospective crossover study.MethodsPrimary open angle glaucoma (POAG) and normotensive glaucoma (NTG) patients were randomized enrolled. Group 1 (“NPT to PT”) patients used preservative-free 0.0015% tafluprost (NPT) for 6 months and then changed to preservative containing 0.0015% tafluprost(PT) for 6 months. Group 2 (“PT to NPT”) patients used preservative containing 0.0015% tafluprost for 6 months and changed to preservative-free 0.0015% tafluprost for 6 months. At 1, 3, 6, 7, 9, and 12 months, we measured intraocular pressure for efficacy and graded corneal erosion, tear break-up time (TBUT), and subjective discomfort.ResultsA total of 20 patients and 20 eyes were enrolled. In Group 1 and 2, intraocular pressure was well controlled to approximately 14 mmHg (9.38–18.46% decrease). Generally, subjective satisfaction was improved after changing from PT to NPT (p = 0.03) and TBUT using PT was numerically inferior to that using NPT (p = 0.06) but not when changing from NPT to PT.ConclusionBoth preservative containing and preservative-free 0.0015% tafluprost reduced intraocular pressure significantly. In addition, changing medication from PT to NPT might improve subjective satisfaction and tear break up time.Trial registrationThe trial registration number is NCT 03104621 (Apr/1/2017). Retrospectively registered.

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“…Substitutions for BAK have been found [8–10] and preservative-free disposable packs for one-timeuse have been developed [11]. …”

Section: Introductionmentioning

confidence: 99%

Efficacy and tolerability of preservative-free 0.0015% tafluprost in glaucoma patients: a prospective crossover study

Lee

Bae

et al. 2017

BMC Ophthalmol

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“…We graded the presence of conjunctival hyperemia between 0 and 3 (Table 1). SPK scores and hyperemia scores were graded using standard-grading photographs 12. IOP was measured three times using a Goldmann applanation tonometer at as close to the same time of day during every visit as possible, and the average value was determined.…”

Section: Methodsmentioning

confidence: 99%

“…We estimated that 70 patients would be required to detect a mean difference of 0.3 in SPK score between week 0 and week 12, with a SD of 0.88,12 at a two-sided α level of 5% and a power of 80%. Considering the possibility of discontinuation of treatment and dropout from the study cohort, we planned to enroll 85 patients at the beginning of this study.…”

Section: Methodsmentioning

confidence: 99%

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The signs of ocular-surface disorders after switching from latanoprost to tafluprost/timolol fixed combination: a prospective study

Okumichi

Kiuchi

Baba³

et al. 2017

OPTH

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PurposeTo evaluate the ocular-surface safety of a 0.001% benzalkonium chloride-containing tafluprost/timolol fixed combination (TTFC) in patients with primary open-angle glaucoma (POAG) or ocular hypertension who have inadequate intraocular pressure (IOP) control with latanoprost monotherapy.MethodsThis study is a multicenter, prospective, single-arm, open-label clinical study. Patients with POAG or ocular hypertension who have inadequate IOP control with latanoprost monotherapy were considered eligible. After providing informed consent, patients continued latanoprost monotherapy for 12 weeks, followed by a switch to TTFC. We evaluated the extent of ocular-surface damage using superficial punctate keratopathy (SPK) score, tear breakup time (TBUT), hyperemia score, IOP, systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate at 0, 4, and 12 weeks after switching.ResultsA total of 68 patients were enrolled, of whom, 64 patients were included in the final analysis. No significant changes in SPK score, TBUT, or hyperemia score were observed at 4 and 12 weeks compared with week 0. IOP decreased significantly at 4 (13.9±2.5 mmHg) and 12 (14.1±2.5 mmHg) weeks, relative to week 0 (15.3±2.7 mmHg). No significant changes in either SBP or DBP were observed during the study, although patients’ mean heart rate decreased significantly after switching to TTFC. Adverse drug reactions to TTFC occurred in seven patients including two incidences of asthma and one of arrhythmia, and no events were serious.ConclusionThe ocular-surface safety of TTFC is not significantly different to that of latanoprost. Furthermore, switching from latanoprost to TTFC in patients with insufficient IOP control has additive IOP-lowering effects. TTFC is an effective approach for patients receiving latanoprost monotherapy who require more intensive IOP reduction.

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“…Known causes of superficial punctate keratopathy (SPK) in children include entropion, keratoconjunctivitis, and eye-drop toxicity [ 1 – 3 ]. However, there are some cases of SPK where the cause is not clearly identified.…”

Section: Introductionmentioning

confidence: 99%

Superficial punctate keratopathy in a pediatric patient was related to adenoid hypertrophy and obstructive sleep apnea syndrome: a case report

Gao

Wang

2018

BMC Ophthalmol

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BackgroundKnown causes of superficial punctuate keratopathy (SPK) in children include entropion, viral infection, blepharokeratoconjunctivitis (BKC), and toxicity of eye drops. However, there are some SPK patients whose causes could not be identified well. Herein, we describe the history, diagnosis, treatment, and prognosis of a rare case.Case presentationTo report a case of superficial punctate keratopathy (SPK) which coexisted with floppy eyelid syndrome (FES) and presented as intermittent red eye and blurred vision in an 11-year-old boy who slept in the prone position. His condition did not improve despite treatment with topical antibiotics (levofloxacin, tobramycin), steroid eye drops (prednisolone), and artificial tears. The patient was diagnosed with tonsil hypertrophy and nasopharyngeal adenoid hypertrophy and obstructive sleep apnea syndrome (OSAS). He underwent tonsillectomy and adenoidectomy. Then he started sleeping in the supine position postoperatively. The SPK, red eye and blurred vision completely resolved after surgery without additional treatment. The corneal sensation also recovered gradually during the next 7 years. However, the floppy eyelid did not resolve.ConclusionRecurrent SPK of childhood might be related to tonsil hypertrophy, adenoid hypertrophy and OSAS, which can be rehabilitated by a surgical approach.

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Comparison of the Toxicity Profile of Benzalkonium Chloride-Preserved Tafluprost and SofZia-Preserved Travoprost Applied to the Ocular Surface

Abstract: SPK, hyperemia score, and tear BUT while using tafluprost with 0.001% BAK were not inferior compared with those caused by travoprost with SofZia.

Cited by 22 publications

References 30 publications

Efficacy and tolerability of preservative-free 0.0015% tafluprost in glaucoma patients: a prospective crossover study

Efficacy and tolerability of preservative-free 0.0015% tafluprost in glaucoma patients: a prospective crossover study

The signs of ocular-surface disorders after switching from latanoprost to tafluprost/timolol fixed combination: a prospective study

Superficial punctate keratopathy in a pediatric patient was related to adenoid hypertrophy and obstructive sleep apnea syndrome: a case report

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