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

NCT03104621 | Completed Phase 4 DMC

• 1 other identifier: 3-2013-0042
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Open-angle Glaucoma

Keywords

preservative-free, tafluprost

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

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); Drug: 0.0015% tafluprost

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(Taflotan®) and then changed to non-preservative disposable 0.0015% tafluprost product(Taflotan-S®) for 6 months.

Drug: Benzalkonium chloride (BAK); Drug: 0.0015% tafluprost

Interventions

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.

Group 1; Group 2

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.

Group 1; Group 2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Primary open angle glaucoma and normotensive glaucoma patients who came to the outpatient clinic for regular glaucoma check-ups were enrolled.
• \. 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).
• \. 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.

You may not qualify if:

• \. Phakic and pseudophakic eyes.
• \. eyes that had been taken vitrectomy, trabeculectomy, or surgery influenced IOP

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Related Publications (1)

• 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.

  PMID: 28454526 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Benzalkonium Compounds; tafluprost

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Gong Je Seong

  Gangnam Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators, patients and other study participants were blinded to treatment assignment throughout the study. Evaluator of IOP was also masked to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: April 7, 2017
• Study Start: March 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: April 7, 2017

Record last verified: 2017-04