The Efficacy and Safety of Travoprost 0.004% versus Tafluprost 0.005% in Primary Open-Angle Glaucoma or Ocular Hypertensive Patients.
- Conditions
- primary open-angle glaucomaocular hypertensionpigment dispersion glaucoma
- Registration Number
- EUCTR2008-006718-10-DE
- Lead Sponsor
- Alcon Laboratories, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Patients must be at least 21 years of age.
Must have a clinical diagnosis of ocular hypertension, primary open-angle, or pigment dispersion glaucoma in at least one eye (qualifying eye).
Must have IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the trial.
Must have an intraocular pressure of between >21 in at least one eye and < 35 mm Hg in both eyes at all diurnal time points at Visit 2
Must have best corrected visual acuity of 6/60 (20/200 Snellen) or better in each eye.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Presence of other primary or secondary glaucomas not listed in inclusion criterion #2.
Presence of extreme narrow angle with complete or partial closure in either eye, as measured by gonioscopy (occludable angles treated with a patent iridectomy are acceptable).
Any abnormality preventing reliable applanation tonometry in study eye(s).
Any opacity or patient uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of the study eye(s).
Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to Visit 1.
Risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator’s best judgment.
Progressive retinal or optic nerve disease from any cause.
Women of childbearing potential not using reliable means of birth control or pregnant or lactating females
Any clinically significant, serious, or severe medical or psychiatric condition.
A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the patient.
Participation in any other investigational study within 30 days prior to Visit 2.
Known medical history of allergy or sensitivity to any components of the preparations to be used in this trial that is deemed clinically significant in the opinion of the Principal Investigator.
Use of systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 7 days prior to Visit 2 or an anticipated change in the dosage during the course of the study.
A history of, or at risk for uveitis or cystoid macular edema (CME).
History of ocular herpes simplex.
Unwillingness to accept the risk of iris, skin, or eyelash changes associated with prostaglandin therapy.
TREATMENT OF SUBJECTS AT PROTOCOL CONCLUSION
In order to meet the inclusion criteria of this protocol, subjects must be considered in need of a change from their current therapy due to reasons of efficacy, tolerability or compliance. Since both investigational products in this trial are currently available marketed products, at the conclusion of the clinical trial if efficacy, tolerability or compliance has improved, the treating physician may elect to prescribe either of the study medications. If not, another market available product may be prescribed.
DATA PROTECTION
As stated in the section 11.2 of the protocol, all appropriate precautions will be taken to maintain confidentiality of medical records and personal information. No personal identifying information will be contained in any report generated by the study. Likewise personal information in the Case Report Forms will be identified by a subject’s initials and study number only.
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Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the efficacy of tafluprost to travoprost, both administered each evening.<br><br>;Secondary Objective: To compare the safety between the two treatment groups.;Primary end point(s): Intraocular pressure at 20:00 hours<br><br>STATISTICAL JUSTIFICATION OF SAMPLE SIZE<br><br>The primary efficacy variable is the mean intraocular pressure at 8 PM compared between tafluprost and taflotan. As typical in many glaucoma protocols, a standard deviation of 2.8 mm Hg is assumed. At least 40 patients must provide data for both treatment periods in order to provide an 80% power that a difference of 1.25 mm Hg can be excluded between groups. As a result, approximately 40 subjects will be included.<br><br>GENDER DISTRIBUTION<br><br>The target diseases, ocular hypertension and glaucoma, affect both genders equally. The response to the study medications, which are both marketed products, has been shown to be substantially the same in both men and women.
- Secondary Outcome Measures
Name Time Method