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

Santen

Status and phase: Completed; Phase 3

Conditions: Open-angle Glaucoma; Ocular Hypertension

Treatments: Drug: Timolol and Tafluprost; Drug: Fixed Dose Combination of tafluprost and timolol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01306461

201051

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety of the preservative-free fixed-dose combination of tafluprost and timolol (FDC) to concomitant administration of tafluprost and timolol.

This study will enroll patients who have ocular hypertension or glaucoma.

The study schedule includes seven visits to the study site and three stages:

• washout of 5 days to 4 weeks depending on current glaucoma medication (if any)
• 6-month study treatment period
• 1-3 weeks post-study period

Enrollment: 401 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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401 participants in 2 patient groups

Timolol and Tafluprost

Active Comparator group

Description:

Concomitant administration of preservative-free timolol and tafluprost eye drops

Treatment:

Drug: Timolol and Tafluprost

Fixed Dose Combination of tafluprost and timolol

Experimental group

Description:

Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops

Treatment:

Drug: Fixed Dose Combination of tafluprost and timolol