A COMPARISON OF LATANOPROST 50µg/ml EYE DROPS vs. XALATAN EYE DROPS IN THE TREATMENT OF OPEN ANGLE GLAUCOMA

A COMPARISON OF LATANOPROST 50µg/ml EYE DROPS vs. XALATAN EYE DROPS IN THE TREATMENT OF OPEN ANGLE GLAUCOMA: AN OPEN, RANDOMIZED, CLINICAL TRIAL - QTM/OMN0111

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002601-30-ES

Enrollment

150

Registered

2011-07-19

Start date

2011-09-26

Completion date

Unknown

Last updated

2022-04-25

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

Conditions

Open angle glaucoma MedDRA version: 14.0 Level: LLT Classification code 10030856 Term: Open-angle glaucoma System Organ Class: 10015919 - Eye disorders

Interventions

Product Name: Latanoprost Pharmaceutical Form: Eye drops INN or Proposed INN: LATANOPROST CAS Number: 130209-82-4 Other descriptive name: 13,14-dihydro-15(R)-17-phenyl-18,19,20-trinor-prostaglandina-2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: >18 years of age Diagnosis of open angle glaucoma, ocular hypertension, pigmentary glaucoma or exfoliation glaucoma Expectation by the investigator that IOP would remain controlled with a single treatment without optic nerve damage or progression of visual field loss. Edad > 18 años 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 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Using topical ocular anti-glaucoma within 14 days prior to the study. Narrow angle glaucoma patients. Ocular surgery or lasser trabelulopalasty carried out within 6 months prior to the study. History of allergic hypersensitivity or poor tolerance to any component of the preparations used in this trial. Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.

Design outcomes

Primary

Measure	Time frame
Main Objective: To explore the clinical efficacy of the Latanoprost 50 µg/ml in comparison with marketed Latanoprost (Xalatan, Pfizer) in the relief open angle glaucoma ;Secondary Objective: To collect information on safety and tolerability of the product under investigation. ;Primary end point(s): Inter Ocular Pressure (IOP) ;Timepoint(s) of evaluation of this end point: Day 1, day 7, day 14 and day 28	—

Measure

Time frame

Main Objective: To explore the clinical efficacy of the Latanoprost 50 µg/ml in comparison with marketed Latanoprost (Xalatan, Pfizer) in the relief open angle glaucoma ;Secondary Objective: To collect information on safety and tolerability of the product under investigation. ;Primary end point(s): Inter Ocular Pressure (IOP) ;Timepoint(s) of evaluation of this end point: Day 1, day 7, day 14 and day 28

—

Secondary

Measure	Time frame
Secondary end point(s): -Best-corrected log MAR visual acuity -Ophthalmoscopy -Ocular discomfort after instillation of the study drug ;Timepoint(s) of evaluation of this end point: Day 1, day 7, day 14 and day 28	—

Countries

Spain

Contacts

Public ContactCRO

Quantum Experimental S.L

aescacena@quantumexperimental.es3491485 53 47

Outcome results

None listed

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