Multi-Center Study Assessing Efficacy and Tolerability of TRAVATAN Solution without BAK, containing Polyquad Preservative in Patients Previously on latanoprost or bimatoprost solution Monotherapy.
- Conditions
- open-angle glaucoma or ocular hypertension who are currently on latanoprost 0.005 or bimatoprost 0.01 ophthalmic solution monotherapyMedDRA version: 14.1Level: HLTClassification code 10018305Term: Glaucomas (excl congenital)System Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2011-003816-21-IT
- Lead Sponsor
- ALCON RESEARCH, LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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
-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. 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, alphaagonists 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 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to assess the efficacy and tolerability of TRAVATAN Solution without<br>BAK, containing Polyquad Preservative after changing from prior latanoprost 0.005% or bimatoprost<br>0.01 ophthalmic solution monotherapy;Secondary Objective: It's the evaluation of the percentages of of patients who reach target IOP (= 18 mmHg). Lastly, Changes in Ocular Surface Disease Index scores, hyperemia levels, as well as patient Questionnaires are considered as the exploratory variables of the study.;Primary end point(s): Change in IOP at the 12 week visit from prior latanoprost or bimatoprost 0.01 ophthalmic solution monotherapy (baseline).;Timepoint(s) of evaluation of this end point: FTER 12 WEEKS OF THE TREATMENT
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Percentage of patients who reach target IOP (= 18 mmHg).;Timepoint(s) of evaluation of this end point: fine studio