E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
primary open-angle glaucoma ocular hypertension pigment dispersion glaucoma |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the efficacy of tafluprost to travoprost, both administered each evening.
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E.2.2 | Secondary objectives of the trial |
To compare the safety between the two treatment groups. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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.
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E.4 | Principal exclusion criteria |
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. Arztservice Wente GmbH’s proprietary website is protected with state of the art techniques, including Secure Socket Layer transport encryption, database level encryption and user-based password authentication with complexity requirements.
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E.5 End points |
E.5.1 | Primary end point(s) |
Intraocular pressure at 20:00 hours
STATISTICAL JUSTIFICATION OF SAMPLE SIZE
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.
GENDER DISTRIBUTION
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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 11 |