Clinical Trials Logo
  1. Home
  2. Glaucoma
  3. NCT05397600
  4. Details
NCT05397600 Clinical Trial

Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients

Glaucoma Clinical Trial

Official title:
Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05397600
Other study ID # LT4032-302
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 22, 2022
Est. completion date March 7, 2024

Study information
Verified date November 2023
Source Laboratoires Thea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main study purpose is to demonstrate the non-inferiority of T4032 compared to Lumigan® 0.01% in terms of efficacy.

Recruitment information / eligibility
Status Completed
Enrollment 684
Est. completion date March 7, 2024
Est. primary completion date March 7, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Informed consent dated and signed. - Both eyes diagnosed open-angle glaucoma or ocular hypertension Exclusion Criteria: - History of trauma, infection, clinically significant inflammation within the previous 3 months - Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s) - Pregnancy or breast-feeding

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bimatoprost Ophthalmic
Eyedrops

Locations
Country Name City State
Colombia Clínica Oftalmológica del Caribe Barranquilla
Colombia Fundación Oftalmológica Nacional (FUNDONAL) Bogotá
Colombia Clinica de Oftalmologia de Cali SA Cali
Colombia Fundación Oftalmológica de Santander FOSCAL Floridablanca
Colombia Instituto Nacional de Investigacion en Oftalmologia Medellin
Colombia Clinica de Oftalmologia Sandiego Medellín
United States Southwest Eye Institute El Paso Texas
United States Scheie Eye Institute Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Laboratoires Thea

Countries where clinical trial is conducted

United States,  Colombia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP. Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP at three time points (8:00 a.m.; 10:00 a.m.; 4:00 p.m.) in the study eye. up to Week12
See also
  Status Clinical Trial Phase
Recruiting NCT06000865 - Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE N/A
Recruiting NCT06278597 - Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device N/A
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Recruiting NCT03274024 - The Asia Primary Tube Versus Trab (TVT) Study N/A
Completed NCT04552964 - Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma N/A
Recruiting NCT01957267 - Functional and Structural Imaging for Glaucoma
Active, not recruiting NCT04624698 - iStent Inject New Enrollment Post-Approval Study N/A
Completed NCT04020705 - The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma N/A
Completed NCT03150160 - Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma Phase 4
Not yet recruiting NCT05581498 - Glaucoma Exercise as Medicine Study (GEMS). N/A
Recruiting NCT02921568 - Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes N/A
Active, not recruiting NCT02901730 - Clinical Study of LPI With Different Laser Wavelengths N/A
Completed NCT02955849 - A Trial of China Laser and Surgery Study Glaucoma in Rural China Early Phase 1
Recruiting NCT02554214 - Pilot Clinical Trial on a New Adjustable Glaucoma Drainage Device N/A
Recruiting NCT02471105 - Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml Phase 4
Active, not recruiting NCT02390284 - Stop Retinal Ganglion Cell Dysfunction Study Phase 3
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A
Completed NCT02520674 - Glaucoma Screening With Smartphone Ophthalmology N/A
Completed NCT02628223 - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma N/A
Completed NCT02246764 - Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension Phase 3