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

• Sponsor: Laboratoires Thea (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05397600
• Collaborator: (none)
• Enrollment: 500
• Locations: 8
• Arms: 2
• Anticipated Duration (Months): 14.3
• Patients Per Site: 62.5
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Ocular Hypertension	Drug: Bimatoprost Ophthalmic	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients
• Actual Study Start Date: Jun 22, 2022
• Anticipated Primary Completion Date: Aug 31, 2023
• Anticipated Study Completion Date: Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: T4032	Drug: Bimatoprost Ophthalmic; Eyedrops
Active Comparator: Lumigan	Drug: Bimatoprost Ophthalmic; Eyedrops

Outcome Measures

Primary Outcome Measures

1. Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP. [up to Week12]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scheie Eye Institute	Philadelphia	Pennsylvania	United States	19104
2	Southwest Eye Institute	El Paso	Texas	United States	79902
3	Clínica Oftalmológica del Caribe	Barranquilla		Colombia	80001
4	Fundación Oftalmológica Nacional (FUNDONAL)	Bogotá		Colombia	110231
5	Clinica de Oftalmologia de Cali SA	Cali		Colombia	760001
6	Fundación Oftalmológica de Santander FOSCAL	Floridablanca		Colombia	681004
7	Instituto Nacional de Investigacion en Oftalmologia	Medellin		Colombia	50024
8	Clinica de Oftalmologia Sandiego	Medellín		Colombia	50021

Sponsors and Collaborators

• Laboratoires Thea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laboratoires Thea
• ClinicalTrials.gov Identifier: NCT05397600
• Other Study ID Numbers: LT4032-302
• First Posted: May 31, 2022
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ocular Hypertension; Bimatoprost

Study Results

No Results Posted as of Jul 19, 2022