MedTrace Logo

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

NCT02017327 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 379

Last updated 2020-04-02

Study results available
· View outcomes & findings →

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

Interventions

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.

Sponsors & Collaborators

  • Laboratoires Thea

    lead INDUSTRY

Principal Investigators

  • Christophe Baudouin, Professor · Hopital des XV-XX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02017327 on ClinicalTrials.gov