glaucoma ocular hypertension glaucoma ocular hypertension ocular surface intraocular pressure fixed dose combination preservative-free timolol tafluprost
Conditions
Interventions
Eligible patient will be switched to use the preservative-free tafluprost 0.0015%/timolol 0.5% fixed combination once daily for 24 weeks of the study period
Experimental Drug
Preservative-free tafluprost 0.0015%/ timolol 0.5% fixed combination
Sponsors
Department of Ophthalmology, Faculty of Medicine, Chiang Mai University
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with established glaucoma or ocular hypertension at Chiang Mai University Hospital 2. Age 18 years or older 3. Different types of unilateral or bilateral glaucoma (primary open angle glaucoma, normal tension glaucoma, primary angle closure glaucoma, pseudoexfoliation glaucoma, and other glaucomas) or ocular hypertension 4. Have prior use of combination therapy of preserved timolol and preserved prostaglandin analogue (other than tafluprost) such as Two topical anti-glaucoma medications: One of them is preservative-containing prostaglandin (latanoprost, travoprost, or bimatoprost) monotherapy. The other medication is preservative-containing timolol 0.5% OR Preservative-containing fixed dose combination of prostaglandin and timolol 0.5% 5. Intraocular pressure not exceeding 22 mmHg at baseline visit 6. Regular use of anti-glaucoma medications as listed in the inclusion criteria (4) for not more than 3 months 7. No other topical medications applied with exception of anti-glaucoma medications and artificial tears 8. With or without previous intraocular/glaucoma surgery 9. Patients who have ocular surface disease due to the usage of preservative-containing anti-glaucoma medications. (At least one eye must have a score above 1 on the NEI scale) 10. If both eyes of a patient are eligible for enrollment, the eye with more ocular surface disease will be chosen for study
Exclusion criteria
Exclusion criteria: 1. Life threatening or debilitating disease 2. Inability to follow instructions as scheduled 3. Patients with pulmonary disease (asthma, chronic obstructive pulmonary disease), heart disease (arrhythmia, heart block) which is contraindication for timolol 0.5% use. 4. Patients with known history of timolol and/or prostaglandins analogs allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular surface change Baseline, 6 weeks, 12 weeks and 24 weeks Visual acuity, Corneal staining, Tear break up time, Schirmer's test, OSDI, Prostaglandin associated periorbitopathy and Conjunctival hyperemia | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraocular pressure Baseline, 6 weeks, 12 weeks and 24 weeks Goldman applanation during 9.00-10.00 am, mean of 2 measurements,Satisfaction of patients Baseline, 6 weeks, 12 weeks and 24 weeks EQ-5D-5L | — |
Countries
Thailand
Contacts
Public ContactAssociate Professor Linda Hansapinyo
Department of Ophthalmology, Faculty of Medicine, Chiang Mai University
Outcome results
None listed