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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021039-14 | EudraCT Number |
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| Name | Class |
|---|---|
| Tampere University | OTHER |
| The Laboratory and Pharmacy Public Utility of the Pirkanmaa Hospital District | UNKNOWN |
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The objective of this study is to investigate corneal confocal microscopic findings, ocular signs and symptoms in patients on treatment with the preserved prostaglandin analogue latanoprost 0.005% eye drops (Xalatan®) and after the switch to preservative-free prostaglandin analog tafluprost 0.0015% eye drops (Taflotan®). Patients who have been using latanoprost as their prior medication (at least 6 months) and who fulfil all the inclusion criteria including the specified ocular symptoms and signs, will switch from latanoprost 0.005% eye drops to the assigned preservative-free tafluprost 0.0015% eye drops for twelve (12) months.
Primary outcome measures:
Change from screening in corneal confocal microscopic findings at month 12
Change from screening in ocular symptoms upon non-instillation at month 12
Change from screening in ocular signs at month 12
Safety and QoL variables:
Descriptive statistics, identification of change(s) from screening
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tafluprost 0.0015% | Experimental | Open, one arm study. Patients who have been using latanoprost 0.005% eye drops (Xalatan®) as their prior medication (at least 6 months) and who fulfil all the inclusion criteria including the specified ocular symptoms and signs, will switch from latanoprost to the assigned preservative-free tafluprost 0.0015% (Taflotan®)eye drops for twelve (12) months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafluprost 0.0015% | Drug | Eye Drops, Solution. Topical Use. One single-unit dose pipet of 0.3 ml solution including 0.0015 mg/ ml of Tafluprost once daily in the affected eye(s)for 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from screening in corneal confocal microscopic findings at month 12 | Baseline and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from screening in ocular symptoms and signs upon non-instillation | Baseline and Month 12 |
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Inclusion Criteria:
At least two ocular symptoms considered for the two eyes together (irritation/burning/stinging, foreign body sensation, tearing, itching or dry eye sensation) of at least mild severity (grade ≥ 2) upon non-instillation OR One ocular symptom of at least mild severity (grade ≥ 2) upon non-instillation AND
At least one of the following ocular signs in either eye with prior treatment:
Fluorescein tear break-up time (fBUT): less than 10 seconds
Corneal and conjunctival fluorescein staining:
Corneal fluorescein staining score of at least grade I OR Combined nasal and temporal staining scores of at least grade II Blepharitis: of at least mild severity (grade ≥ 1) Conjunctival redness/hyperemia: of at least mild severity (grade 1) Tear production: 10 mm or less on Schirmer test
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hannu Uusitalo, MD, PhD | Clinical Trial Center, FinnMedi Oy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FinnMedi Oy, Clinical Trial Center | Tampere | Pirkanmaa District | 33520 | Finland |
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| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D005901 | Glaucoma |
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| ID | Term |
|---|---|
| C485333 | tafluprost |
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