| A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma. |
| A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study Evaluating The Efficacy And Safety Of Latanoprost And Timolol In Pediatric Subjects With Glaucoma. |
| To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are diagnosed with glaucoma. |
| Not Provided |
| Interventional |
| Phase 3 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment |
| Glaucoma |
|
|
|
|
| Not Provided |
| |
| Completed |
| 139 |
| November 2009 |
| November 2009 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Male or female of 18 years of age or under
- Diagnosis of glaucoma
- IOP of 22 mmHg or above in at least 1 eye
Exclusion Criteria:
- Require surgery for acute angle closure
- Have had prior cyclodestructive procedures
- Have a history of ocular trauma or surgery in either eye within 3 months of the baseline visit
|
| Sexes Eligible for Study: |
All |
|
| 36 Weeks to 18 Years (Child, Adult) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Belgium, Colombia, Czech Republic, France, Germany, India, Italy, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Ukraine, United Kingdom, United States |
| |
| |
| NCT00716859 |
| A6111137 |
| Yes |
| Not Provided |
| Not Provided |
| Director, Clinical Trial Disclosure Group, Pfizer Inc |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| January 2011 |
