Tafluprost Preservative Free Switch Study

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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)