Phase 3 N=485 Randomized Single-blind Treatment

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

Ocular Hypertension · Glaucoma

Bottom Line

View on ClinicalTrials.gov: NCT03825380 ↗

Enrolled (actual)

485

Serious AEs

0.6%

Results posted

Nov 2023

Primary outcome: Primary: Intra-Ocular Pressure — -9.67; -9.50 mmHg — p=0.453

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Bimatoprost (Drug); Lumigan® (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Laboratoires Thea
Primary completion: Feb 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Intra-Ocular Pressure	-9.67; -9.50	0.453

Summary

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03825380). 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.