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

Study Overview
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Brief Summary
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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.

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

Conditions
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Primary Open-angle Glaucoma

Intervention / Treatment
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* Drug: Benzalkonium chloride (BAK)
* Drug: 0.0015% tafluprost


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>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. | Drug: Benzalkonium chloride (BAK)<br>* Benzalkonium chloride (BAK) is the most used preservative and is excellent for safety and stability of drug. However, it causes dry eye, corneal oedema, corneal erosion, and corneal toxicities, thus lowering the long-term tolerability for patients. A critical component when managing glaucoma patients is ensuring compliance.<br>Drug: 0.0015% tafluprost<br>* Tafluprost (trade names Taflotan or Taflotan-S by Santen Pharmaceutical) is a prostaglandin analogue. It is used topically (as eye drops) to control the progression of open-angle glaucoma and in the management of ocular hypertension. In this study, tafluprost was used in all experimental group with equally concentration(0.0015%), only measured whether BAK was included or not.<br>|
| Experimental: Group 2<br>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. | Drug: Benzalkonium chloride (BAK)<br>* Benzalkonium chloride (BAK) is the most used preservative and is excellent for safety and stability of drug. However, it causes dry eye, corneal oedema, corneal erosion, and corneal toxicities, thus lowering the long-term tolerability for patients. A critical component when managing glaucoma patients is ensuring compliance.<br>Drug: 0.0015% tafluprost<br>* Tafluprost (trade names Taflotan or Taflotan-S by Santen Pharmaceutical) is a prostaglandin analogue. It is used topically (as eye drops) to control the progression of open-angle glaucoma and in the management of ocular hypertension. In this study, tafluprost was used in all experimental group with equally concentration(0.0015%), only measured whether BAK was included or not.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of corneal erosion grade by preservative free 0.0015% tafluprost | 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 | after 1, 3, and 6 months using drug in group 1/ after 7, 9, and 12 months using drug in group 2 | 
| The change of tear break up time by preservative free 0.0015% tafluprost | 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) | after 1, 3, and 6 months using drug in group 1/ after 7, 9, and 12 months using drug in group 2 | 
| The change of Schirmer test by preservative free 0.0015% tafluprost | 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) | after 1, 3, and 6 months using drug in group 1/ after 7, 9, and 12 months using drug in group 2 | 
| The change of corneal erosion grade by preservative contained 0.0015% tafluprost | 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 | after 1, 3, and 6 months using drug in group 2/ after 7, 9, and 12 months using drug in group 1 | 
| The change of tear break up time by preservative contained 0.0015% tafluprost | 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) | after 1, 3, and 6 months using drug in group 2/ after 7, 9, and 12 months using drug in group 1 | 
| The change of Schirmer test by preservative contained 0.0015% tafluprost | 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) | after 1, 3, and 6 months using drug in group 2/ after 7, 9, and 12 months using drug in group 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preservative-free, tafluprost