The evaluation of ocular surface changes after switching to preservative-free tafluprost 0.0015%/ timolol 0.5% fixed combinatio

Phase 4

Recruiting

• Conditions: glaucomaocular hypertension; glaucoma; ocular hypertension; ocular surface; intraocular pressure; fixed dose combination; preservative-free; timolol; tafluprost

• Registration Number: TCTR20220225004
• Lead Sponsor: Department of Ophthalmology, Faculty of Medicine, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-25
• Study Completion: 2023-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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