Phase 3
N=139
A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT00716859 ↗Enrolled (actual)
139
Serious AEs
6.6%
Results posted
Dec 2010
Primary outcome: Primary: Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF) — 5.72; 7.18 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Timolol (Drug); latanoprost (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF) |
5.72; 7.18 | — |
| SECONDARY Reduction From Baseline in Mean IOP at Week 1 |
6.02; 6.70 | — |
| SECONDARY Reduction From Baseline in Mean IOP at Week 4 |
5.37; 6.99 | — |
| SECONDARY Reduction From Baseline in Mean IOP at Week 12 (Observed) |
6.96; 7.75 | — |
| SECONDARY Mean IOP at Baseline |
27.8; 27.3 | — |
| SECONDARY Mean IOP at Week 1 |
21.7; 20.6 | — |
| SECONDARY Mean IOP at Week 4 |
21.5; 20.1 | — |
| SECONDARY Mean IOP at Week 12 |
19.8; 19.2 | — |
| SECONDARY Percentage of Participants With Greater Than or Equal to (≥) 15% IOP Reduction From Baseline at Both Weeks 4 and 12 |
52; 60 | 0.3315 |
| SECONDARY Percentage of Participants Discontinuing Therapy Due to a Drug-related Adverse Experience |
1.4; 0 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00716859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.