Efficacy Study of Travoprost APS Versus… | Clinical Trial

Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 years of age or older, either gender and any race.
Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT).
Not currently on any IOP-lowering medication or currently on a stable treatment (i.e, at least 30 days) with and IOP-lowering monotherapy.
All patients: Mean IOP in same eye (at both Eligibility 1 & 2 Visits):

≥ 24 and ≤ 36 mmHg at 9 AM; and ≥ 21 and ≤ 36 mmHg at 11 AM & 4 PM.

Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Females of childbearing potential not meeting conditions set in the protocol.
Severe central visual field loss.
Angle Shaffer grade < 2.
Cup/disc ratio > 0.8 (horizontal or vertical measurement).
Best corrected visual acuity (VA) score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal).
Intraocular surgery or trauma within last 6 months.
Any abnormality preventing reliable applanation tonometry.
History of or current ocular pathology (including severe dry eye) that would affect the conduct of the study.
Allergy/hypersensitivity to study medications.
Unable to discontinue use of all IOP-lowering medications for a minimum wash-out period of 5 to 28 days prior to the Eligibility Visit.
Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP.
Use of any additional topical or systemic ocular hypotensive medication during the study.
Therapy with another investigational agent within 30 days prior to the Screening visit.
Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution

Drug

One drop once daily in the evening for 3 months

Travoprost 0.004% (BAK-preserved) Eye Drops, Solution

Drug

One drop once daily in the evening for 3 months

Primary outcomes

Mean Intraocular Pressure at 9:00 am

Time frame: 3 months (measured at 9:00 am)

For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg

All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.

Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis
Mean Intraocular Pressure at 11:00 am

Time frame: 3 months (measured at 11:00 am)

For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg

All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.

Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis
Mean Intraocular Pressure at 4:00 pm

Time frame: 3 months (measured at 4:00 pm)

For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg

All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.

Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

A Multi-Center, Double-Masked Study of the Safety and Efficacy of Travoprost APS Compared to TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Feb 20, 2009
Registry last updated: Apr 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed