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

Phase 4

Completed

• Conditions: Primary Open-angle Glaucoma
• Interventions: Drug: Benzalkonium chloride (BAK); Drug: 0.0015% tafluprost

• Registration Number: NCT03104621
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2014-09
• Study Completion: 2015-09
• Study First Submitted: 2017-03-13
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-01
• Last Update Submitted: 2017-04-01
• Study First Posted: 2017-04-07
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Benzalkonium chloride (BAK)	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.
Group 1	0.0015% tafluprost	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.
Group 2	Benzalkonium chloride (BAK)	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.
Group 2	0.0015% tafluprost	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.

Primary Outcome Measures

Name	Time	Method
The change of corneal erosion grade by preservative free 0.0015% tafluprost	after 1, 3, and 6 months using drug in group 1/ after 7, 9, and 12 months using drug in group 2	Corneal erosion scales were scored according to the area of erosion. Little to no erosion was "0", erosion on 1/3 of the area of the entire cornea was "1", erosion on 2/3 of the area of the entire cornea was "2", and erosion on the entire cornea was "3"
The change of tear break up time by preservative free 0.0015% tafluprost	after 1, 3, and 6 months using drug in group 1/ after 7, 9, and 12 months using drug in group 2	Tear breakup time was checked by slit lamp exam under corneal fluorescein dye. We asked patients not to blink, and the time was counted until tear film was torn apart (seconds)
The change of tear break up time by preservative contained 0.0015% tafluprost	after 1, 3, and 6 months using drug in group 2/ after 7, 9, and 12 months using drug in group 1	Tear breakup time was checked by slit lamp exam under corneal fluorescein dye. We asked patients not to blink, and the time was counted until tear film was torn apart (seconds)
The change of Schirmer test by preservative contained 0.0015% tafluprost	after 1, 3, and 6 months using drug in group 2/ after 7, 9, and 12 months using drug in group 1	or tear secretion, schirmer test paper was placed into the conjunctival sac at the point of 1/3 from lateral canthus under topical anaesthesia (5% Proparacaine HCl, Alcaine®, Alcon Laboratories Inc., TX, USA). After 5 minutes, we checked the wet height with tear (mm)
The change of Schirmer test by preservative free 0.0015% tafluprost	after 1, 3, and 6 months using drug in group 1/ after 7, 9, and 12 months using drug in group 2	For tear secretion, schirmer test paper was placed into the conjunctival sac at the point of 1/3 from lateral canthus under topical anaesthesia (5% Proparacaine HCl, Alcaine®, Alcon Laboratories Inc., TX, USA). After 5 minutes, we checked the wet height with tear (mm)
The change of corneal erosion grade by preservative contained 0.0015% tafluprost	after 1, 3, and 6 months using drug in group 2/ after 7, 9, and 12 months using drug in group 1	Corneal erosion scales were scored according to the area of erosion. Little to no erosion was "0", erosion on 1/3 of the area of the entire cornea was "1", erosion on 2/3 of the area of the entire cornea was "2", and erosion on the entire cornea was "3"