Comparison of Efficacy and Tolerability of a New Preservative-free Formulation of Travoprost 40 µg/ml Eye Drops vs. Travatan? Eye Drops in Patients with Primary Open Angle Glaucoma or Ocular Hypertension

Open, Observer-blind, two Parallel Group, Randomized, Multicentric Clinical Phase III Trial on the Comparison of Efficacy and Tolerability of a New Preservative-free Formulation of Travoprost 40 µg/ml Eye Drops vs. Travatan? Eye Drops in Patients with Primary Open Angle Glaucoma or Ocular Hypertension - QTM/OMN0112

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000026-22-ES

Enrollment

170

Registered

2012-02-03

Start date

2012-07-23

Completion date

Unknown

Last updated

2022-05-23

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

Conditions

Primary open angle glaucoma or intraocular hypertension MedDRA version: 14.1 Level: PT Classification code 10030043 Term: Ocular hypertension System Organ Class: 10015919 - Eye disorders MedDRA version: 14.1 Level: LLT Classification code 10036719 Term: Primary open angle glaucoma System Organ Class: 10015919 - Eye disorders

Interventions

Product Name: Travoprost Pharmaceutical Form: Eye drops, solution CAS Number: 157283-68-6 Other descriptive name: TRAVOPROST Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? male or female patients, of any race and ?18 years of age; ? diagnosed of unilateral or bilateral primary open angle glaucoma or ocular hypertension; ? on treatment with an IOP-lowering prostaglandin analogue for at least 6 months; ? on treatment with an IOP ?21 mmHg on medication measured as a mean of both eyes at two measurements at least one hour apart; ? best-corrected visual acuity ?20 of 100 corresponding to logMAR of 0.7 in both eyes; ? in case of women, postmenopausal (>12 months without menstrual bleeding), surgically sterilized, or on use of effective birth control measures; ? expected by the investigator that IOP would remain controlled with the new treatment without optic nerve damage or progression of visual field loss; ? able to understand the requirements of the clinical trial and to agree to return for required follow-up visits; ? willing to provide voluntary written informed consent and data protection declaration before any clinical trial related procedure is performed. 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 170 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ? pre-treatment for primary open angle glaucoma or intraocular hypertension other than prostaglandin analogues; ? a history of chronic or recurrent inflammatory eye disease, ocular trauma or infections; ? narrow-angle/angle-closure glaucoma; ? clinically significant or progressive retinal disease; ? intraocular surgery within the past 6 months; ? ocular laser surgery within the past 3 months; ? a change in glaucoma therapy within 1 month before the screening visit; ? best-corrected visual acuity worse than 0.7 logarithm of minimal angle of resolution (logMAR) score, extremely narrow or partially closed angle, cup/disk ratio >0.8; ? history of bronchial asthma, or severe chronic obstructive pulmonary disease; reactive airway disease including bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease. ? treatment with local or systemic corticosteroids; ? inability to discontinue the use of glucocorticoid medications; ? not receiving stable doses of any medication that could affect IOP for 30 days before the beginning of the clinical trial (e.g. clonidine);

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this clinical trial is to demonstrate the non-inferiority of the investigational medicinal product containing preservative-free Travoprost (40 µg/ml) in comparison with the commercially available preservative-containing comparator Travatan? (Alcon Laboratories Ltd., UK) in the treatment of primary open angle glaucoma or ocular hypertension by the average decrease of diurnal IOP measured between baseline and last visit;Secondary Objective: Secondary efficacy objectives are the average decreases of diurnal IOP measured between baseline and days 7 and 14 and the proportion of patients with measured IOP <21 mmHg at the end of the clinical trial.;Primary end point(s): Diurnal IOP measured by ocular tonometry (Goldmann Applanation Tonometry);Timepoint(s) of evaluation of this end point: Day 1, day 7, day 14 and day 28	—

Measure

Time frame

Main Objective: The primary objective of this clinical trial is to demonstrate the non-inferiority of the investigational medicinal product containing preservative-free Travoprost (40 µg/ml) in comparison with the commercially available preservative-containing comparator Travatan? (Alcon Laboratories Ltd., UK) in the treatment of primary open angle glaucoma or ocular hypertension by the average decrease of diurnal IOP measured between baseline and last visit;Secondary Objective: Secondary efficacy objectives are the average decreases of diurnal IOP measured between baseline and days 7 and 14 and the proportion of patients with measured IOP <21 mmHg at the end of the clinical trial.;Primary end point(s): Diurnal IOP measured by ocular tonometry (Goldmann Applanation Tonometry);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): - blood pressure and heart rate - subjective expected ocular signs upon instillation; - objective ocular signs (lid and slit lamp examination and ophthalmoscopy); - visual acuity; - ocular and systemic AEs; - safety laboratory values at the beginning and at end of treatment.;Timepoint(s) of evaluation of this end point: Day 1, day 7, day 14 and day 28	—

Countries

Spain

Contacts

Public ContactMiriam

Omnivision GmbH

004908984079253

Outcome results

None listed

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