Efficacy and Tolerability of Preservative-free 0.0015% Tafluprost in Glaucoma Patients

Yonsei University Health System (YUHS)

Status and phase: Completed; Phase 4

Conditions: Primary Open-angle Glaucoma

Treatments: Drug: Benzalkonium chloride (BAK); Drug: 0.0015% tafluprost

Study type: Interventional

Funder types: Other

Identifiers

NCT03104621

3-2013-0042

Details and patient eligibility

About

The aim of this work is to evaluate efficacy and tolerability of preservative containing 0.0015% tafluprost and preservative-free 0.0015% tafluprost. Both preservative containing and preservative-free 0.0015% tafluprost will reduce intraocular pressure significantly. In addition, preservative-free 0.0015% tafluprost might improve tolerability of glaucoma patients.

Enrollment: 20 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 1. Primary open angle glaucoma and normotensive glaucoma patients who came to the outpatient clinic for regular glaucoma check-ups were enrolled.
• 2. Glaucoma was defined as the patients who had open angle confirmed by gonioscopy, optic nerve cupping (a vertical cup-disc ratio of >0.6) and or notching of the neuroretinal rim and or retinal nerve fiber defects characteristics of glaucoma, and visual field defect(i.e., a glaucoma hemi-filed test result outside normal limits, a pattern standard deviation probability of <5%, or a cluster of three or more non-edge points in location typical of glaucoma, all of which were depressed on a pattern deviation plot at a P level of <5%, and at least one of which was depressed at a P level of <1% on two consecutive visual field tests).
• 3. Normal tension glaucoma included criteria: repeated measurements of untreated IOP values of < 21mmHg. Primary open angle glaucoma included criteria: repeated measurements of untreated IOP values of ≥ 22mmHg.

Exclusion criteria

• 1. Phakic and pseudophakic eyes.
• 2. eyes that had been taken vitrectomy, trabeculectomy, or surgery influenced IOP

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Group 1

Experimental group

Description:

Group 1, for the first 6 months, the subjects of group 1 used non-preservative disposable 0.0015% tafluprost product(Taflotan-S®) and then changed to 0.001% Benzalkonium chloride (BAK), 0.0015% tafluprost product (Taflotan®)for 6 months.

Treatment:

Drug: 0.0015% tafluprost

Drug: Benzalkonium chloride (BAK)

Group 2

Experimental group

Description:

Group 2, for the first 6 months, the subjects of group 2 used 0.001% Benzalkonium chloride (BAK), 0.0015% tafluprost product(Taflotan®) and then changed to non-preservative disposable 0.0015% tafluprost product(Taflotan-S®) for 6 months.

Treatment:

Drug: 0.0015% tafluprost

Drug: Benzalkonium chloride (BAK)