Tafluprost-Timolol Fixed Dose Combination Non-Inferiority Study Against Concomitant Administrations

Launched by SANTEN OY · Feb 28, 2011

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • Aged 18 years or more
• • A diagnosis of ocular hypertension or open-angle glaucoma
• • Meet specific IOP level at visit 1 (screening)and visit 2 (baseline)
• • Meet specific visual acuity score
• • Are willing to follow instructions
• • Have provided a written informed consent
• Exclusion Criteria:
• • Females who are pregnant, nursing or planning pregnancy
• • IOP greater than 36 mmHg at any time point at screening or baseline
• • Diagnosis of angle-closure glaucoma or secondary glaucoma other than capsular or pigmentary glaucoma in either eye
• • Suspected contraindication or hypersensitivity to study medications tafluprost or timolol (e.g. asthma, low pulse) or to wash-out medication brinzolamide
• • Glaucoma filtration surgery or any other ocular surgery (including ocular laser procedures) within 6 months prior to Screening
• • Use of contact lenses at Screening or during the study
• • Presence of any abnormality or significant illness that could be expected to interfere with the patient safety or study parameters
• • Current participation in another clinical trial within the last 30 days