[A multicentre, observative, non-invasive study of the tolerance of NYOLOL gel 0,1% in ocular hypertensive patients].
OBJECTIVE
To evaluate the safety and efficacy of Nyolol Gel 0,1%/Novartis vs. regular timolol formulation (Ofterisin 0,5%) in ocular hypertensive patients.


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.
Stankiewicz
Andrzej
A
Z Kliniki Okulistycznej Wojskowego Instytutu Medycznego w Warszawie.
Wierzbowska
Joanna
J
D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D019370:Observation; D009798:Ocular Hypertension / Q000175:diagnosis / Q000188:drug therapy*; D011446:Prospective Studies; D012720:Severity of Illness Index; D013999:Timolol / Q000627:therapeutic use*
D000319:Adrenergic beta-Antagonists; D000959:Antihypertensive Agents; D005782:Gels; D013999:Timolol