An Evaluation of Patient Reported Outcomes and Ocular Surface Health in Patients Using Travoprost APS Eye Drops Solution Versus XALATAN Eye Drops Solution - Travoprost APS versus XALATAN in OSDI
- Conditions
- Open Angle Glaucoma or Ocular HypertensionMedDRA version: 9.1Level: LLTClassification code 10030043Term: Ocular hypertensionMedDRA version: 9.1Level: LLTClassification code 10030348Term: Open angle glaucoma
- Registration Number
- EUCTR2009-010606-10-LV
- Lead Sponsor
- Alcon Research, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 516
All patients must meet the following criteria:
1. Patients = 18 years of age.
2. Must have a clinical diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension in at least one eye.
3. Must have a corneal fluorescein staining score of = 1 in at least one eye
Note: If the patient is currently dosing with XALATAN® in only one eye, the eye being dosed must be the one with corneal staining. If the patient is currently dosing both eyes, staining must be present in at least one eye. Scoring should be based on staining that is, in the opinion of the investigator, typical of staining found in patients with chronic use of preserved eye drops.
4. Must have had their IOP controlled with mono-therapy using latanoprost 50 micrograms/ml eye drops (XALATAN®) for at least 1 continuous month immediately prior to Visit 1.
5. The intraocular pressure should be able to be controlled in the opinion of the Investigator and stable while on mono-therapy with the study medication for the eye(s) currently being dosed with XALATAN®.
6. Must have an intraocular pressure in both eyes that, in the opinion of the Investigator, is considered to be stable and safe for the patient.
7. The last dose of XALATAN® must have been instilled the evening prior to Visit 1.
8. Must be willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study.
NOTE: This includes discontinuation of any artificial tears.
9. Best-corrected visual acuity score of = 55 ETDRS in each eye (see Section 18.1.2. for details on the procedure).
10. Women of childbearing potential must meet all of the following conditions at Visit 1:
•They are not breast-feeding.
•They have a negative urine pregnancy test at Visit 1.
•They agree to undertake a urine pregnancy test upon entering and exiting the study.
•They are not planning to become pregnant during the course of the study.
•They are currently using, and agree to continue to use adequate birth control methods for the duration of the study. Adequate birth control methods are defined as:
Hormonal: oral, implantable, topical, or injectable contraceptives
Mechanical: IUD, spermicide in conjunction with a barrier such as condom or diaphragm
Surgical: sterilization of partner and / or self
Abstinence: If patients become sexually active, they must agree to use one of the birth control methods (hormonal, mechanical, or surgical) listed above.
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
Patients demonstrating any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in this study, or that may in the opinion of the Investigator, affect the results of this study SHOULD NOT be enrolled. The following are specific conditions that exclude patients from enrollment in this study:
1. Any abnormality preventing reliable applanation tonometry in the study eye(s).
2. Presence of any ocular pathology in either eye seen during the slit lamp or fundus exams, that in the opinion of the Investigator may preclude the safe administration of test article or safe participation in this study.
3. Dry eye or KCS currently being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
4.Patients with suspected or diagnosed Sjogren’s syndrome currently being treated with with punctal plugs, punctal cautery, other topical ocular medications or the use of systemic therapy (e.g., RESTASIS® or EVOXAC®).
5. Patients who have undergone keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface, including but not limited to LASIK and PRK, within 6 months prior to Visit 1.
6. Any other ocular laser surgery in either eye within 3 months prior to Visit 1.
7. Patients who have undergone intraocular or extra-ocular surgery, in either eye, within 6 months prior to Visit 1.
8. History of progressive retinal or optic nerve disease other than glaucoma.
9. Severe central visual field loss in either eye based upon the clinical judgment of the investigator. For Humphrey and Octopus perimeters severe central visual field loss is defined as a sensitivity of less than or equal to 10 dB in at least two (2) of the four (4) visual field test points closest to the point of fixation.
10. Any history of ocular infections or inflammatory ocular conditions within the past 3 months in either eye. These conditions may include, but are not limited to:
•Clinically significant blepharitis (requiring pharmacological treatment) within 3 months prior to Visit 1.
NOTE: Non-clinically significant (does not require pharmacological treatment) or prostaglandin-induced conjunctival injection and blepharitis are allowed.
•Rosacea affecting the eye adnexa and its ocular sequelae (i.e., hordeola, chalazion, recurrent meibomian gland dysfunction);
•Clinically significant corneal dystrophies (defined as affecting the structure of the corneal surface or best corrected visual acuity, or is an actively changing or unstable condition);
•History of chronic or recurrent inflammatory eye diseases (e.g., uveitis, scleritis, herpes keratitis, iritis, etc);
11. Ocular trauma within 6 months prior to Visit 1 in either eye, as determined by patient history and/or examination.
12. Use of any systemic medications on a chronic basis that have not been on a stable dosing regimen for at least 30 days prior to Visit 1, or an anticipated change in dosing regimen of medications during the course of the study.
NOTE: During the course of the 90-day study, short-term use of certain
over-the-counter medications for such ailments as headache, cough, gastrointestinal upset, diarrhea, arthritis, etc., will be allowed, provided that these medications, in the opinion of the Investigator, will not substantially alter the integrity of the ocular surface during the study. The use of certain migraine medications such as sumatriptan succinate, rizatriptan
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary statistical objective is to describe differences between Travoprost APS and XALATAN® for mean NEI VFQ-25 composite (Visual Function) score at the end of the three-month treatment period in patients with open-angle glaucoma or ocular hypertension. ;Secondary Objective: NA;Primary end point(s): The primary efficacy variable is mean VFQ-25 composite (Visual Function) score at the end of the treatment period (Day 90). A two-sample t-test will be used to test for differences between treatments in the means.
- Secondary Outcome Measures
Name Time Method