Tafluprost Preservative Free Switch Study

Phase 4

Completed

• Conditions: Glaucoma; Ocular Hypertension; Primary Open Angle Glaucoma
• Interventions: Drug: preservative free tafluprost 0.0015%

• Registration Number: NCT04654611
• Lead Sponsor: Tun Hussein Onn National Eye Hospital

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.

Detailed Description

Importance: Glaucoma medications are often preserved with agents such as benzalkonium chloride, which commonly lead to ocular surface diseases.

Background: To investigate the effect of switching to a preservative-free prostaglandin analogue, tafluprost 0.0015% on treatment tolerability and ocular surface diseases.

Design: This was a prospective, open label, non-randomised, observational study performed in a single hospital.

Participants: Patients of Asian descent who have primary open angle glaucoma and ocular hypertension (n = 28), who received preserved prostaglandin monotherapy for longer than 3 months, and has a National Eye Institute ocular surface staining scale score higher than 1.

Methods: Patients were switched from preserved prostaglandin monotherapy to preservative-free tafluprost 0.0015%. Patients were analysed at baseline (Visit 0), 1 month (Visit 1) and 3 months (Visit 2).

Main Outcome Measures: The main parameter measured is the change in the fluorescein staining score at Visit 2.

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01
• Study First Submitted: 2020-11-23
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-01
• Last Update Submitted: 2020-12-01
• Study First Posted: 2020-12-04
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Age of 21 years or older and those who can provide informed consent.
2. Patients who have corneal disorders due to the prostaglandin usage. (At least one eye must have a score above 1 on the NEI scale)
3. Intraocular pressure (IOP) ≤ 21 mm Hg in the study eye at the screening examination (under treatment)
4. 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.
5. 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.
6. Outpatients who can visit the clinic on the designated day as instructed by the physician.
7. A best-corrected ETDRS visual acuity score of +0.6 logMAR (Snellen equivalent of 20 ⁄ 80) or better in each eye.

Exclusion Criteria

1. Those with severe visual field disorder (Mean deviation of 15 dB or worse)
2. 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.
3. Those with severe dry eye (those in need of drug to treat dry eye), ocular allergy, ocular infection or ocular inflammation
4. 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
5. Female patients who are pregnant, nursing or lactating
6. 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
7. Those who need to wear contact lenses during the study period
8. Any corneal abnormality or other condition preventing reliable applanation tonometry
9. Anterior chamber angle less than grade 2 according to Schaffer classification as measured by Gonioscopy
10. Any uncontrolled systemic disease (e.g. hypertension, diabetes)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Changes in the fluorescein staining score (NEI) at Visit 2	3 months	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)

Trial Locations

Locations (1)

THONEH; 🇲🇾 Petaling Jaya, Selangor Darul Ehsan, Malaysia