Clinical trial NCT01510145: Efficacy of Changing to TRAVATAN® From Prior Therapy
Official title: Multi-Center Study Comparing Efficacy and Tolerability of TRAVATAN® BAK-free (0.004% Travoprost) in Patients Previously on Latanoprost Ophthalmic Solution 0.005% Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open-angle Glaucoma
Ocular Hypertension
Keywords: Glaucoma
Open-angle glaucoma
Ocular hypertension
Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-01-13
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® solution without BAK (benzalkonium chloride) after changing from prior latanoprost 0.005% ophthalmic solution monotherapy in subjects with open-angle glaucoma or ocular hypertension due to tolerability issues.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye;
* On latanoprost ophthalmic solution 0.005% monotherapy (including BAK-containing generics) for at least 4 weeks prior to the Screening Visit, but would benefit from a switch to TRAVATAN® BAK-free because of tolerability issues, in the opinion of the investigator;
* Intraocular pressure (IOP) \<30 millimeters of mercury (mmHg) in both eyes while on latanoprost ophthalmic solution 0.005% monotherapy;
* IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that assured clinical stability of vision and the optic nerve throughout the study period;
* Willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study;
* Able to follow instructions and willing and able to attend all study visits;
* Best corrected Snellen visual acuity of 6/60 (20/200; 1.0 LogMAR) or better in each eye;
* Must sign an informed consent form;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study deemed clinically significant in the opinion of the Principal Investigator;
* Any abnormality preventing reliable applanation tonometry in either eye;
* Corneal dystrophies in either eye;
* Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye;
* Any clinically significant, serious, or severe medical condition;
* Use of any systemic medications known to affect IOP which have not been on a stable course for at least 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study;
* Severe 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;
* Intraocular conventional surgery or laser surgery in either eye less than 3 months prior to the Screening Visit;
* Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment;
* Progressive retinal or optic nerve disease from any cause;
* Women who are pregnant, lactating, or not using reliable means of birth control;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percentage of Subjects Who Reach Target IOP (≤18 mmHg)
timeFrame: Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Adriana S. Bonadia
role: STUDY_DIRECTOR
References:
citation: Lopes JF, Hubatsch DA, Amaris P. Effect of benzalkonium chloride-free travoprost on intraocular pressure and ocular surface symptoms in patients with glaucoma previously on latanoprost: an open-label study. BMC Ophthalmol. 2015 Nov 12;15:166. doi: 10.1186/s12886-015-0151-7.