A 6-month, Randomized, Double-masked Comparison of Fixed Combination of Latanoprost and Timolol With the Individual Components, Continuing Into a 6-month Open Label Safety Study of Fixed Combination in Patients With Glaucoma or Ocular Hypertension. A Multicenter Study in the United States

NCT00800267 Phase 3 COMPLETED

Safety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts.

Details

Lead sponsor	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	418
Start date	1997-07
Completion	1999-06

Conditions

• Ocular Hypertension
• Glaucoma

Interventions

• latanoprost 0.005%
• fixed combination latanoprost-timolol
• timolol 0.5%

Primary outcomes

• The differences from baseline in diurnal IOP reduction after six months of treatment will be tested between the fixed combination and the monotherapy groups. — 6 months
• Primary objective: to demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies. — 6 months

Countries

United States