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

• Sponsor: Laboratoires Thea (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03825380
• Collaborator: (none)
• Enrollment: 485
• Location: 1
• Arms: 2
• Actual Duration (Months): 27.1
• Patients Per Site Per Month: 17.9

Study Details

Study Description

Brief Summary

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

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 485 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients
• Actual Study Start Date: Nov 23, 2018
• Actual Primary Completion Date: Feb 3, 2021
• Actual Study Completion Date: Feb 24, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Intra-Ocular Pressure [Week 12]

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital	Tallinn		Estonia

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: NCT03825380
• Other Study ID Numbers: LT4032-301
• First Posted: Jan 31, 2019
• Last Update Posted: Jul 28, 2021
• Last Verified: Jul 1, 2021

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

Study Results

No Results Posted as of Jul 28, 2021