Tafluprost Preservative Free Switch Study

NCT04654611 | Completed Phase 4 DMC

• 1 other identifier: 001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted to document the effect of switching from preserved prostaglandin analogues monotherapy to preservative free tafluprost 0.0015%. The endpoints analyzed are side effect improvement in these patients.

Conditions

Glaucoma; Primary Open Angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Changes in the fluorescein staining score (NEI) at Visit 2

  The fluorescein stained area of the cornea will be measured according to the National Eye Institute/Industry (NEI/I) method. NEI grading scale consists of a grid that divides the corneal area into five sections, each of which is assigned a score between zero and 3 depending of the amount and distribution of Corneal Fluorescein Stain (CFS); the total CFS score ranges from 0/15 (absence of corneal epitheliopathy) to 15/15 (severe epitheliopathy)

  3 months

Study Arms (1)

Treatment group

OTHER

The intervention will be preservative free tafluprost 0.0015% topical ophthalmic solution given once daily for the study duration.

Drug: preservative free tafluprost 0.0015%

Interventions

preservative free tafluprost 0.0015% DRUG

preservative free prostaglandin analogue option for treatment of primary open angle glaucoma and ocular hypertension patients

Treatment group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 21 years or older and those who can provide informed consent.
• Patients who have corneal disorders due to the prostaglandin usage. (At least one eye must have a score above 1 on the NEI scale)
• Intraocular pressure (IOP) ≤ 21 mm Hg in the study eye at the screening examination (under treatment)
• If only one eye is eligible, it is to be evaluated. If both eyes are eligible, then the eye with a higher NEI score will be selected for evaluation.
• Pretreatment must be monotherapy with any of the following preserved ophthalmic solutions; latanoprost, travoprost, bimatoprost or tafluprost and its period must be longer than 3 months.
• Outpatients who can visit the clinic on the designated day as instructed by the physician.
• A best-corrected ETDRS visual acuity score of +0.6 logMAR (Snellen equivalent of 20 ⁄ 80) or better in each eye.

You may not qualify if:

• Those with severe visual field disorder (Mean deviation of 15 dB or worse)
• Those with a history of ocular surgeries (such as corneal refractive surgery, intraocular surgery including ocular laser treatment which may affect the patient's ocular surface condition) within 6 months prior to the study initiation.
• Those with severe dry eye (those in need of drug to treat dry eye), ocular allergy, ocular infection or ocular inflammation
• Those who need to use systemic or ophthalmic steroids (excluding topical skin steroidal ointment) and anti-glaucoma agents other than latanoprost, travoprost, bimatoprost or preservative free tafluprost ophthalmic solution
• Female patients who are pregnant, nursing or lactating
• Those with a history of drug allergy (hypersensitivity) to the drugs to be used during the study period (anesthetic ophthalmic solution, fluorescein, etc.) or similar drugs to the investigational product
• Those who need to wear contact lenses during the study period
• Any corneal abnormality or other condition preventing reliable applanation tonometry
• Anterior chamber angle less than grade 2 according to Schaffer classification as measured by Gonioscopy
• Any uncontrolled systemic disease (e.g. hypertension, diabetes)

Sponsors & Collaborators

• Tun Hussein Onn National Eye Hospital: lead

Study Sites (1)

THONEH

Petaling Jaya, Selangor, 46200, Malaysia

Location

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Hsien Han Lim

  Tun Hussein Onn National Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Ophthalmology Senior Registrar

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 4, 2020
• Study Start: February 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: December 4, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)