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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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This cross-over study will investigate the efficacy and safety of BIMMD and TUDPF in a clinical setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumigan 0.01% + Saflutan 15 µg/ml | Experimental | Bimatoprost 0.01 % Eye drops solution Topical use Once in the evening 3 months |
|
| Saflutan 15 µg/ml + Lumigan 0.01% | Experimental | Tafluprost Unit Dose Preservative Free 15microgram/ml Eye drops solution Topical use Once in the evening 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preserved Bimatoprost 0.01% | Drug | Eye drops solution Topical use Once in the evening 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| the difference in mean IOP values between the 2 groups | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| the difference in IOP values between the groups in change from baseline IOP | month 3 and month 6 | |
| the difference in mean IOP between the 2 groups | month 3 | |
| the difference in IOP between the 2 groups at each timepoints |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ingeborg Stalmans, Phd | Contact | 003216332372 | ingeborg.stalmans@uzleuven.be | |
| Sien Boons | Contact | 0032163340391 | sien.boons@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Ingeborg Stalmans, Phd | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hommer Ophthalmology Institute | Recruiting | Vienna | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33818170 | Derived | Lemmens S, Rossetti L, Oddone F, Sunaric-Megevand G, Hommer A, Vandewalle E, Francesca Cordeiro M, McNaught A, Montesano G, Stalmans I. Comparison of preserved bimatoprost 0.01% with preservative-free tafluprost: A randomised, investigator-masked, 3-month crossover, multicentre trial, SPORT II. Eur J Ophthalmol. 2021 Apr 5:11206721211006573. doi: 10.1177/11206721211006573. Online ahead of print. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 26, 2023 | |
| Reset | Feb 1, 2024 |
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|
| Tafluprost Unit Dose Preservative Free 15microgram/ml | Drug | Eye drops solution Topical use Once in the evening 3 months |
|
|
| month 3 and month 6 |
| UZ Leuven | Recruiting | Leuven | Vlaams Brabant | 3000 | Belgium |
|
| San Paolo Hospital | Not yet recruiting | Milan | Italy |
|
| Bietti Foundation | Not yet recruiting | Rome | Italy |
|
| Clinical Research Centre Momorial A. de Rotschild | Not yet recruiting | Geneva | Switzerland |
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| Gloucestershire Hospitals NHS Foundation Trust | Not yet recruiting | Gloucestershire | United Kingdom |
|
| Western Eye Hospital | Not yet recruiting | London | United Kingdom |
|
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 26, 2023 | Feb 1, 2024 |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C485333 | tafluprost |
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