Travoprost MDPF 3 Month Safety and Efficacy Study

A Multicente, Observer-Masked Study of the Safety and Efficacy of MDPF Travoprost, 0.004% Compared to TRAVATAN in Patients with Open-Angle Glaucoma or Ocular Hypertension - Travoprost MDPF 3 Month Safety and Efficacy Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003851-20-SE

Enrollment

720

Registered

2012-01-03

Start date

2012-01-11

Completion date

Unknown

Last updated

2012-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open-Angle Glaucoma or Ocular Hypertension MedDRA version: 14.1 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension System Organ Class: 10015919 - Eye disorders

Interventions

Product Name: Travoprost Ophthalmic Solution, 0.004% Product Code: MDPF Travoprost Pharmaceutical Form: Eye drops INN or Proposed INN: Travoprost CAS Number: 157283-68-6 Other descriptive name: TRAVOP

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients 18 yrs or older Diagnosis of Open-Angle glaucoma Qualifying mean IOP at the eligibility visits Able to understand and sign an informed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 720 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Women of childbearing potential (ie, those who are not postmenopausal for at least 1 year or surgically sterile) are excluded from participation if they are currently pregnant,have a positive result on the urine pregnancy test at Screening, or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy 2. Modified Shaffer angle Grade < 2 as measured by gonioscopy (extreme narrow angle with complete or partial closure). 3. Cup/disc ratio (C/D) greater than 0.80 (horizontal or vertical measurement). 4. Severe central visual field loss defined as a sensitivity = 10 dB in at least 2 of the 4 visual field test points closest to the point of fixation. 5. Patients who in the opinion of the Investigator cannot safely undergo the initial wash-out period discontinuing all IOP-lowering ocular medication(s) for a minimum of 4 to 27 days prior to the E1 Visit.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate that the IOP-lowering efficacy of Travoprost Ophthalmic Solution, 0.004%, MDPF is equivalent to TRAVATAN in patients with open-angle glaucoma or ocular hypertension;Secondary Objective: ;Primary end point(s): Intraocular pressure (IOP) / The primary endpoint is an assessment of IOP at 8 AM, 10 AM and 4 PM for each on-therapy visit (Week 2, Week 6, and Month 3);Timepoint(s) of evaluation of this end point: 8 AM, 10 AM and 4 PM for each on-therapy visit (Week 2, Week 6, and Month 3)	—

Measure

Time frame

Main Objective: To demonstrate that the IOP-lowering efficacy of Travoprost Ophthalmic Solution, 0.004%, MDPF is equivalent to TRAVATAN in patients with open-angle glaucoma or ocular hypertension;Secondary Objective: ;Primary end point(s): Intraocular pressure (IOP) / The primary endpoint is an assessment of IOP at 8 AM, 10 AM and 4 PM for each on-therapy visit (Week 2, Week 6, and Month 3);Timepoint(s) of evaluation of this end point: 8 AM, 10 AM and 4 PM for each on-therapy visit (Week 2, Week 6, and Month 3)

—

Countries

Argentina, Australia, Israel, Mexico, Singapore, Sweden, United States

Contacts

Public ContactInez Carels

SA Alcon Couvreur NV

inez.carels@alconlabs.com+32 38902820

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026