NCT02017327

Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01 % and Lumigan® 0.03% Unit Dose

Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01% and Lumigan® 0.03% Unit Dose, in Patients With Primary Open Angle Glaucoma or Ocular Hypertension, Stabilized by Lumigan® 0.01% With Ocular Surface Intolerance

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 379 (actual)
• Sponsor: Laboratoires Thea · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Primary objective: The primary objective is to demonstrate the superiority of Monoprost® versus Lumigan® 0.01% and Lumigan® 0.03% Unit Dose in term of safety with respect to the assessment of conjunctival hyperaemia in the worse eye at Day 84. The conjunctival hyperaemia will be scored using the MacMonnies photographic scale (0 to 5).

Conditions

• Primary Open Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Monoprost	Monoprost®: Latanoprost 0.005% ophthalmic preparation is a sterile unpreserved oil-based solution for topical ophthalmic use. It is supplied in 0.30 ml single use polyethylene containers. The batch numbers and reanalysis dates will be stated in the certificate of analysis.
DRUG	Lumigan 0.01%	Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container.
DRUG	Lumigan 0.03% Unit Dose	Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers.

Timeline

• Start date: 2013-12-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2013-12-20
• Last updated: 2020-04-02
• Results posted: 2020-04-02

Locations

1 site across 1 country: France