DuoTrav APS Versus XALACOM® in Ocular Surface Health

NCT00912054 | Terminated Phase 3

• 1 other identifier: C-09-007
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate superiority of DuoTrav APS over XALACOM® in Ocular Surface Health in patients with open angle glaucoma or ocular hypertension.

Conditions

Open Angle Glaucoma; Ocular Hypertension

Keywords

OAG; OH

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline (Day 0) in Ocular Surface Disease at the end of the treatment period (Day 90)

  Visits 1 and 3

Secondary Outcomes (1)

• Percent of patients with a corneal fluorescein staining score of 0 at the end of the treatment period (Day 90)

  Visit 3 (Day 90)

Study Arms (2)

1

EXPERIMENTAL

DuoTrav APS

Drug: DuoTrav APS

2

ACTIVE COMPARATOR

Xalacom

Drug: Xalacom

Interventions

DuoTrav APS DRUG

travoprost APS 40 micrograms/ml / timolol 5 mg/ml, Eye Drops, Solution, once daily

1

Xalacom DRUG

XALACOM® (latanoprost 50 micrograms/ml / timolol 5 mg/ml) Eye Drops, Solution

2

Eligibility Criteria

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

You may qualify if:

• Patients ≥ 18 years of age.
• Must have a clinical diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension in at least one eye.
• Must be willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study.
• Must have had IOP controlled with mono-therapy using XALACOM for at least 1 continuous month prior to Visit 1.
• Women of childbearing potential must meet all specific conditions at Visit 1:

You may not qualify if:

• Any abnormality preventing reliable applanation tonometry in the study eye(s).
• Presence of any ocular pathology in either eye seen during the slit lamp or fundus exams that may preclude the safe administration of test article or safe participation in this study.
• Dry eye or KCS which has been, or is currently being, treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
• Patients who have undergone keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface, within 1 year prior to Visit1
• Any other ocular laser surgery in either eye within 3 months
• Patients who have undergone intraocular or extra-ocular surgery, in either eye, within 6 months prior to Visit 1.
• History of other progressive retinal or optic nerve disease.
• Severe central visual field loss in either eye based upon the clinical judgment of the investigator.
• Any history of, or current evidence of, infectious or inflammatory ocular conditions
• Ocular trauma within 6 months prior to Visit 1 in either eye, as determined by patient history and/or examination.
• History or evidence of corneal transplant or transplant variant procedures
• Patients with suspected or diagnosed Sjogren's syndrome.
• History of or current bronchial asthma, or severe chronic obstructive pulmonary disease
• History of or current severe, unstable or uncontrolled cardiovascular, hepatic, or renal disease.
• History of spontaneous or current hypoglycemia or uncontrolled diabetes.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Cliniques Universitaires Saint Luc

Brussels, Belgium

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Xalacom

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

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: June 1, 2009
• First Posted: June 3, 2009
• Study Start: March 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 19, 2012

Record last verified: 2012-01

Locations

BE (1)