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The study investigated the 24-hour efficacy and ocular surface health with preservative-free tafluprost and a combined preservative-free regimen (tafluprost and dorzolamide/timolol fixed combination) in open-angle glaucoma patients insufficiently controlled on latanoprost monotherapy and showing signs, or symptoms of ocular surface disease with preservative-containing latanoprost monotherapy. This trial randomized open-angle glaucoma patients insufficiently controlled (IOP > 20 mm Hg) on branded, or generic latanoprost monotherapy who required further IOP reduction and who demonstrated clinical signs, or symptoms of ocular surface disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tafluprost drops | Active Comparator | Treatment with preservative-free talfuprost drops administered once in the evening. Evaluation of 24-hour efficacy and ocular surface health after 3 months of therapy. |
|
| Tafluprost and dorzolamide/timolol drops | Active Comparator | Concomitant therapy with preservative-free talfuprost drops administered once in the evening and dorzolamide/timolol fixed combination drops given twice daily. Evaluation of 24-hour efficacy and ocular surface health after 3 months of therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tafluprost | Drug |
|
| |
| tafluprost and dorzolamide/timolol |
| Measure | Description | Time Frame |
|---|---|---|
| Mean 24-hour efficacy (average intraocular pressure readings over 24 hours) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean 24-hour peak intraocular pressure | 3 months | |
| Mean 24-hour fluctuation of intraocular pressure | 3 months | |
| Corneal staining |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Anastasios G Konstas, MD, PhD | Chair | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27913991 | Derived | Konstas AG, Boboridis KG, Kapis P, Marinopoulos K, Voudouragkaki IC, Panayiotou D, Mikropoulos DG, Pagkalidou E, Haidich AB, Katsanos A, Quaranta L. 24-Hour Efficacy and Ocular Surface Health with Preservative-Free Tafluprost Alone and in Conjunction with Preservative-Free Dorzolamide/Timolol Fixed Combination in Open-Angle Glaucoma Patients Insufficiently Controlled with Preserved Latanoprost Monotherapy. Adv Ther. 2017 Jan;34(1):221-235. doi: 10.1007/s12325-016-0448-9. Epub 2016 Dec 2. |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C485333 | tafluprost |
| C062765 | dorzolamide |
| D013999 | Timolol |
| C479140 | dorzolamide-timolol combination |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Drug |
|
|
| 3 months |
| Break-up time of tear film | 3 months |
| D020005 |
| Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |