Skip to main content
OpenTrials
Completed

NCT Number: NCT03104621

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Open-Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. The change of corneal erosion grade by preservative free 0.0015% tafluprost

    Time frame: 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"

  2. The change of tear break up time by preservative free 0.0015% tafluprost

    Time frame: 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)

  3. The change of Schirmer test by preservative free 0.0015% tafluprost

    Time frame: 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)

  4. The change of corneal erosion grade by preservative contained 0.0015% tafluprost

    Time frame: 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"

  5. The change of tear break up time by preservative contained 0.0015% tafluprost

    Time frame: 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)

  6. The change of Schirmer test by preservative contained 0.0015% tafluprost

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Apr 7, 2017
Registry last updated
Apr 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.