Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the additive effect on eye pressure of Azopt and Alphagan P to Travatan.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hermann Eye Center
• Collaborator: Alcon Research
• Treatments: Brimonidine Tartrate; Brinzolamide; Ophthalmic Solutions; Travoprost

Criteria

Inclusion Criteria:

• Minimum age: 35 years

• Uni or bilateral primary open angle glaucoma, ocular hypertension or pseudoexfoliation syndrome (POAG is defined as having VF and optic nerve changes consistent with glaucomatous disease)

• Insufficient response to monotherapy: defined as IOP > 18mm Hg (mean diurnal) and less than 32 mm Hg on Travatan at baseline

• Informed consent and HIPPA consent obtained at screening visit prior to any study events

• Ability to adhere to study treatment visit plan

Exclusion Criteria:

• Closed, occluded, or potentially occludable angle

• History of angle closure

• Previous intraocular surgery, except uncomplicated clear cornea phacoemulsification or argon laser trabeculoplasty

• Argon laser trabeculoplasty or phacoemulsification within the last 3 months

• Central corneal thickness outside the 500 - 600 (inclusive) micron range as measured by ultrasonic pachymetry

• Ocular or periocular inflammation within 3 months prior to study (except blepharitis related or seasonal allergic conjunctivitis)

• History of uveitis or previous intraocular inflammation (other than post-operatively)

• Hypersensitivity to sulfa, alpha agonists or benzalkonium chloride

• History of use of any steroids for over 1 week within 3 months of screening or likely need for any corticosteroids during the study (except inhaled, nasal or topical non-ocular)

• Use of systemic medications known to effect IOP (e.g. Alpha agonists, Beta blockers, Ace inhibitors and angiotensin II receptor blockers) which have not been stable for three months prior to baseline and the dosage is not expected to change during the course of the study

Women

• Pregnancy (study medications have been determined to cause possible harm to the fetus)

• Women of childbearing potential who are not using contraceptive methods. Childbearing potential is defined as any woman who is not postmenopausal (12 months without a menstrual period) or surgically sterile. Contraceptive methods are defined as abstinence, having a vasectomized partner, or ongoing use of approved oral, injectable, topical or implanted contraceptives, a barrier method or an IUD

General:

• Use of any investigational medication within one month prior to baseline visit