Efficacy Study of Travoprost APS Versus TRAVATAN

Ocular Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00848536
• Other study ID #: C-08-40
• Secondary ID: 2008-006027-31
• Status: Completed
• Phase: Phase 3
• First received: February 19, 2009
• Last updated: April 4, 2012
• Start date: March 2009
• Est. completion date: January 2010

Study information

• Verified date: April 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Drug:
• Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution
One drop once daily in the evening for 3 months
• Travoprost 0.004% (BAK-preserved) Eye Drops, Solution
One drop once daily in the evening for 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Intraocular Pressure 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	3 months (measured at 9:00 am)	No
Primary	Mean Intraocular Pressure 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	3 months (measured at 11:00 am)	No
Primary	Mean Intraocular Pressure 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	3 months (measured at 4:00 pm)	No