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NR 4-5/2004
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Wieloośrodkowe,
obserwacyjne, nieinwazyjne badanie tolerancji preparatu NYOLOL
żel 0,1% u pacjentów z podwyższonym ciśnieniem wewnątrzgałkowym
A multicentre, observative,
non-invasive study of the tolerance of NYOLOL Gel 0,1% in ocular
hypertensive patients
Andrzej Stankiewicz, Joanna Wierzbowska
Z Kliniki Okulistycznej Wojskowego Instytutu Medycznego w
Warszawie
Kierownik: prof. dr hab. n. med. Andrzej Stankiewicz |
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| Summary: |
Purpose: To
evaluate the safety and efficacy of Nyolol Gel 0,1%/Novartis
vs. regular timolol formulation (Oftensin 0,5%) in
ocular hypertensive patients.
Material and methods: A comparative, multicentred
non-invasive, 16-weeks study. 192 glaucoma or ocular
hypertensive patients were randomized into 2 groups:
patients receiving regular timolol treatment (group I)
and patients treated with timolol gel formulation. After
8 weeks of assigned treatment subjects from group I were
switched to Nyolol gel and the subjects from group B –
to regular timolol respectively. Intraocular pressure (IOP),
objective and subjective tolerance of treatment were
evaluated.
Results: There were no differences between groups
as far as level of IOP was concerned. The incidence of
ocular adverse events was higher when patients were
switched to timolol aqueous eye drops. Subjective local
tolerance of timolol gel formulation was better than
conventional eye drops.
Conclusions: Timolol 0,1% gel formulation with a
once daily application provides an IOP reduction
equivalent to timolol 0,5% solution given twice a day.
Local tolerability and safety of gel formulation is
better than aqueous solution, both in the patient’s and
physician’s opinions. |
| Słowa kluczowe: |
timolol żel, timolol
roztwór wodny, profil bezpieczeństwa, tolerancja
leczenia, skuteczność leczenia. |
| Key words: |
timolol gel formulation,
regular timolol formulation, safety profile, tolerance
of treatment, efficacy of treatment. |
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