Safety and Efficacy Study of Bimatoprost, Latanoprost, and Travoprost in Patients With Elevated Intraocular Pressure (IOP) and Open-angle Glaucoma (OAG)

NCT00716742 | Completed Results

• 1 other identifier: Pro2
• Study Type: observational
• Target: 1,099
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effectiveness of the newer IOP-lowering therapies, as prescribed in normal clinical practice, in larger patient numbers. Patients will be assessed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year

  Change from baseline in bilateral (both eyes) IOP at the 1 year follow-up visit. IOP is a measure of the fluid pressure inside the eye. The bilateral IOP was calculated as an average between both eye's IOP. A negative number change from baseline indicates reduction in IOP (improvement).

  Baseline, 1 Year

Study Arms (1)

1

bimatoprost 0.03% latanoprost 0.005% travoprost 0.004%

Drug: bimatoprost 0.03%, latanoprost 0.005%, and travoprost 0.004%

Interventions

bimatoprost 0.03%, latanoprost 0.005%, and travoprost 0.004% DRUG

1 drop in eye(s) every evening

Also known as: Lumigan®, Xalatan®, Travatan®

1

Eligibility Criteria

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

Study Population

Patients can be either: (a) newly diagnosed and require, in the judgment of the treating physician, one of study agents as first-line treatment, (b) have an insufficiently controlled IOP on their current medication (any but not more than two in combination), and a treatment switch to one of study agents is an acceptable option.

You may qualify if:

• A diagnosis of Primary Open-Angle Glaucoma or Ocular Hypertension newly diagnosed OR presenting with insufficiently controlled IOP on current medication (in the opinion of the treating physician)
• Patient is having both eyes treated

You may not qualify if:

• Contraindications per product labelling will apply.
• Patients with any ophthalmic co-morbidity with an influence on visual field deterioration or optic nerve head damage.

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Murfreesboro, Tennessee, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Bimatoprost; Latanoprost; Travoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Limitations and Caveats

Data for 2-year and 3-year follow-up not interpretable due to extremely high drop out rates.

Results Point of Contact

• Title: Vice President, Global Health Outcomes Strategy and Research
• Organization: Allergan, Inc.

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 16, 2008
• Study Start: September 1, 2004
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2009
• Last Updated: January 6, 2012
• Results First Posted: January 6, 2012

Record last verified: 2011-11

Locations

US (1)