Efficacy Study of Travoprost APS Versus TRAVATAN

NCT00848536 | Completed Phase 3 Results

• 2 other identifiers: C-08-402008-006027-31
• Study Type: interventional
• Target: 371
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Open Angle Glaucoma; Ocular Hypertension

Keywords

OAG; OHT

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (2)

TRAVATAN APS

EXPERIMENTAL

One drop once daily in the evening for 3 months

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

TRAVATAN

ACTIVE COMPARATOR

One drop once daily in the evening for 3 months

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

Interventions

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

One drop once daily in the evening for 3 months

TRAVATAN APS

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

One drop once daily in the evening for 3 months

TRAVATAN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Travoprost; Ophthalmic Solutions; Solutions

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pharmaceutical Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Director Alcon Clinical
• Organization: Alcon Research, Ltd.

888.451.3937 or 817.568.6725

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2009
• First Posted: February 20, 2009
• Study Start: March 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: April 6, 2012
• Results First Posted: March 8, 2011

Record last verified: 2012-04