Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
28 participants
INTERVENTIONAL
2019-02-01
2020-02-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment group
The intervention will be preservative free tafluprost 0.0015% topical ophthalmic solution given once daily for the study duration.
preservative free tafluprost 0.0015%
preservative free prostaglandin analogue option for treatment of primary open angle glaucoma and ocular hypertension patients
Interventions
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preservative free tafluprost 0.0015%
preservative free prostaglandin analogue option for treatment of primary open angle glaucoma and ocular hypertension patients
Eligibility Criteria
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Inclusion Criteria
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
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)
21 Years
ALL
No
Sponsors
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Tun Hussein Onn National Eye Hospital
OTHER
Responsible Party
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Thanendthire Sangapillai
Principal Investigator, Ophthalmology Senior Registrar
Principal Investigators
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Hsien Han Lim
Role: PRINCIPAL_INVESTIGATOR
Tun Hussein Onn National Eye Hospital
Locations
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THONEH
Petaling Jaya, Selangor, Malaysia
Countries
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Other Identifiers
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001
Identifier Type: -
Identifier Source: org_study_id