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| ID | Type | Description | Link |
|---|---|---|---|
| A6111066 |
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The primary objective of this study was to compare the change in intraocular pressure (IOP) of three different doses of latanoprost (75, 100 and 125 ug/ml) to that of the marketed 50 ug/ml dose, in a dose ranging study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| latanoprost 75 ug | Experimental |
| |
| latanoprost 100 ug | Experimental |
| |
| latanoprost 125 ug | Experimental |
| |
| latanoprost 50 ug | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| latanoprost 75 ug | Drug | Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL). Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint was the change in intraocular pressure (IOP) at 8 AM and 4 PM from baseline to Week 4 (Day 28). | Baseline and Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| The change in intraocular pressure (IOP) at 8 AM and 4 PM from baseline across all clinic visits; comparisons were made by separate analyses for each time point and visit. | Baseline and Day 28 | |
| The percentage change in IOP from baseline at 8 AM to Week 4 (Day 28). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Associates Pty Limited | Sydney | New South Wales | 2000 | Australia | ||
| Save Sight Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22607109 | Derived | Eveleth D, Starita C, Tressler C. A 4-week, dose-ranging study comparing the efficacy, safety and tolerability of latanoprost 75, 100 and 125 mug/mL to latanoprost 50 mug/mL (xalatan) in the treatment of primary open-angle glaucoma and ocular hypertension. BMC Ophthalmol. 2012 May 18;12:9. doi: 10.1186/1471-2415-12-9. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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|
| latanoprost 100 ug | Drug | Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL). Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit. |
|
| latanoprost 125 ug | Drug | Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL). Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit. |
|
| latanoprost 50 ug | Drug | Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL). Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit. |
|
| Baseline and Day 28 |
| Ocular safety assessments (ie, ocular adverse events, assessment of conjunctival hyperemia, and ocular symptom evaluations) across all clinic visits. | Baseline and Day 28 |
| Sydney |
| New South Wales |
| 2000 |
| Australia |
| Royal Adelaide Hospital, North Terrace | Adelaide | South Australia | 5000 | Australia |
| University Hospital Brno-Bohunice | Brno | CZ - 62500 | Czechia |
| Specializovana Glaukomova Poradna, Blanicka 25 | Prague | 120 00 | Czechia |
| VseobecnBfakultnf nemocnice | Prague | 128 21 | Czechia |
| Private Ophthalmology, V Hurkach 1296 | Prague | 150 00 | Czechia |
| Institute of Aviation Medicine, Generalal Piky 1 | Prague | 160 60 | Czechia |
| Hopital De La Timone | Marseille | France |
| Hopital Des Armees Laveran | Marseille | France |
| Fondation Adolphe De Rothchild | Paris | 75016 | France |
| Hopital Civil | Strasbourg | France |
| Akadimos Ophthalmology Center of Northern Greece | Thessaloniki | Greece |
| Layton Rahmatullah Benevolent Trust (LRBT), Eye Hospital | Lahore | Punjab Province | Pakistan |
| Services Hospital Lahore | Lahore | Punjab Province | Pakistan |
| Aga Khan University Hospital Karachi | Karachi | Sindh | Pakistan |
| Civil Hospital Karachi | Karachi | Sindh | Pakistan |
| A.I.B.I.L.I. | Coimbra | 3000 | Portugal |
| Hospital De S. Jose | Lisbon | Portugal |
| Hospital Pedro Hispano | Matosinhos Municipality | Portugal |
| Siriraj Hospital, Ophthalmology | Bangkok | 10700 | Thailand |
| Chulalongkorn Hospital | Bangkok | Thailand |
| Birmingham Heartlands Hospital | Birmingham | B9 5SS | United Kingdom |
| Glasgow Royal Infirmary | Glasgow | G4 0SF | United Kingdom |
| Sunderland Eye Infirmary | Sunderland | SR2 9HP | United Kingdom |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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