Clinical trial NCT03104621: Efficacy and Tolerability of Preservative-free 0.0015% Tafluprost in Glaucoma Patients
Official title: Efficacy and Tolerability of Preservative-free 0.0015% Tafluprost in Glaucoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Open-angle Glaucoma
Keywords: preservative-free, tafluprost
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The change of corneal erosion grade by preservative free 0.0015% tafluprost
timeFrame: after 1, 3, and 6 months using drug in group 1/ after 7, 9, and 12 months using drug in group 2
measure: The change of tear break up time by preservative free 0.0015% tafluprost
timeFrame: after 1, 3, and 6 months using drug in group 1/ after 7, 9, and 12 months using drug in group 2
measure: The change of Schirmer test by preservative free 0.0015% tafluprost
timeFrame: after 1, 3, and 6 months using drug in group 1/ after 7, 9, and 12 months using drug in group 2
measure: The change of corneal erosion grade by preservative contained 0.0015% tafluprost
timeFrame: after 1, 3, and 6 months using drug in group 2/ after 7, 9, and 12 months using drug in group 1
measure: The change of tear break up time by preservative contained 0.0015% tafluprost
timeFrame: after 1, 3, and 6 months using drug in group 2/ after 7, 9, and 12 months using drug in group 1
measure: The change of Schirmer test by preservative contained 0.0015% tafluprost
timeFrame: after 1, 3, and 6 months using drug in group 2/ after 7, 9, and 12 months using drug in group 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Gangnam Severance Hospital
name: Gong Je Seong
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.