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Clinical Trials/NCT03825380
NCT03825380CompletedPhase 3

Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients

Laboratoires Thea1 site in 1 country485 target enrollmentStarted: November 23, 2018Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
485
Locations
1
Primary Endpoint
Intra-Ocular Pressure
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to assess the efficacy and safety of T4032 versus Lumigan.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Informed consent signed and dated.
  • •Both eyes with diagnosed open-angle glaucoma or ocular hypertension

Exclusion Criteria

  • •History of trauma, infection, clinically significant inflammation within the 3 previous months.
  • •Uncontrolled diabetic patient.
  • •Pregnancy or breast feeding.

Arms & Interventions

Lumigan®

Active Comparator

Intervention: Lumigan® (Drug)

T4032

Experimental

Intervention: Bimatoprost (Drug)

Outcomes

Primary Outcomes

Intra-Ocular Pressure

Time Frame: Week 12

Change from Baseline to Week 12 in Intra Ocular Pressure in mmHg in the worse eye

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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