Open angle Glaucoma Ocular Hypertension MedDRA version: 14.0 Level: PT Classification code 10030043 Term: Ocular hypertension System Organ Class: 10015919 - Eye disorders MedDRA version: 14.0 Level: PT Classification code 10030348 Term: Open angle glaucoma System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: TRAVATAN
Product Name: TRAVATAN
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: Travoprost
CAS Number: 157283-68-6
Current Sponsor code: Travatan
Concentration unit: µg/ml mi
Sponsors
S.A. Alcon-Couvreur N.V
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Must be at least 18 years of age. 2.Must have a clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye. 3.Must be on either latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy (including BAK containing generics) for at least 4 weeks prior the Screening Visit but, in the opinion of the investigator, would benefit from a switch to TRAVATAN® Solution without BAK, containing Polyquad® Preservative because of tolerability issues. 4.IOP less than 30 mmHg in both eyes while on latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy. 5.Must have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period. 6.In the eye that is not included in the study, the IOP should be able to be controlled on no pharmacologic therapy or on the study medicine alone. 7.Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study. 8.Must be able to follow instructions and be willing and able to attend all study visits. 9.Must have best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye. 10.An Ethics Committee reviewed and approved (for use in this study) informed consent form must be read, signed, and dated by the participating patient, as well as signed and dated by the individual (Principal Investigator or other site personnel) obtaining the informed consent, before conducting the Screening Visit and prior to initiation of study procedures. 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: 1.Known medical history of allergy, hypersensitivity or poor tolerance to any components of the preparations to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator. 2.Any abnormality preventing reliable applanation tonometry in either eye. 3.Corneal dystrophies in either eye. 4.Any opacity or patient uncooperativeness that restricts adequate examination of the anterior chamber of either eye. 5.Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. 6.Severe dry eye, or Dry eye or keratoconjunctivitis sicca which has been, or is currently being, treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids. 7.Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit. 8.Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator’s best judgment. 9.Progressive retinal or optic nerve disease from any cause. 10.A history of, or at risk for uveitis or cystoid macular edema (CME). 11.Use of any 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 at least 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study. 12.Any clinically significant, serious, or severe medical condition. 13.Women of childbearing potential not using reliable means of birth control. A reliable effective method of birth control must have been used for at least one month prior to Visit 1 and is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed. 14.Women who are pregnant or lactating 15.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. 16.Participation in any other investigational study within 30 days prior to the Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Change in IOP (on TRAVATAN® Solution without BAK, containing Polyquad® Preservative) at the 12 week visit from prior latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy (baseline).;Secondary Objective: Percentage of patients who reach target IOP (= 18 mmHg).;Primary end point(s): Change in IOP (on TRAVATAN® Solution without BAK, containing Polyquad® Preservative) at the 12 week visit from prior latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy (baseline).;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percentage of patients who reach target IOP (= 18 mmHg).;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Belgium, Italy, Spain, Sweden
Contacts
Public ContactProject Management
Genexion SA
Outcome results
None listed