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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Group 1, for the first 6 months, the subjects of group 1 used non-preservative disposable 0.0015% tafluprost product(Taflotan-SĀ®) and then changed to 0.001% Benzalkonium chloride (BAK), 0.0015% tafluprost product (TaflotanĀ®)for 6 months. |
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| Group 2 | Experimental | Group 2, for the first 6 months, the subjects of group 2 used 0.001% Benzalkonium chloride (BAK), 0.0015% tafluprost product(TaflotanĀ®) and then changed to non-preservative disposable 0.0015% tafluprost product(Taflotan-SĀ®) for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benzalkonium chloride (BAK) | Drug | 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. |
| 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, AlcaineĀ®, 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gong Je Seong | Gangnam Severance Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28454526 | Derived | Lee W, Lee S, Bae H, Kim CY, Seong GJ. Efficacy and tolerability of preservative-free 0.0015% tafluprost in glaucoma patients: a prospective crossover study. BMC Ophthalmol. 2017 Apr 28;17(1):61. doi: 10.1186/s12886-017-0453-z. |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D001548 | Benzalkonium Compounds |
| C485333 | tafluprost |
| ID | Term |
|---|---|
| D050339 | Benzylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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Investigators, patients and other study participants were blinded to treatment assignment throughout the study. Evaluator of IOP was also masked to treatment assignment.
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| 0.0015% tafluprost | Drug | 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. |
|
| 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, AlcaineĀ®, 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 |
| D009861 |
| Onium Compounds |