Tear concentration study and quality of life on patients treated with unpreserved latanoprost 0.005%

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-Patients aged 18 years or older with ocular hypertension or chronic open-angle glaucoma treated with preserved latanoprost 0.005% during at least 6 months.
-Patients capable of signing informed consent and of complying with the protocol.
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

Ocular exclusion criteria
-Patients diagnosed with other eye diseases capable of altering the ocular surface (altered blinking function or eyelid anatomy, corneal dystrophy of any kind, ectasias, etc.).
-Any eye disease or surgery requiring topical treatment during the 6 months before the study.
-Patients with established glaucoma or ocular hypertension failing to respond to prostaglandins or which cannot be controlled with a single antiglaucoma drug.
-Patients with severe visual field loss.
-Patients who are using or have used antiglaucoma eyedrops different from the study products or preserved artificial tears in the previous 6 months.
-Patients with a history of ocular trauma, infection or inflammation.
-Patients wearing contact lenses on the inclusion visit and throughout the study.
-Patients who have undergone any kind of eye surgery (including laser refractive surgery, intraocular surgery and eyelid surgery) capable of modifying the patient?s corneal surface.
-Patients who will require surgery in the course of the study.
-Patients with herpetic keratitis or a history of herpetic keratitis.
-Patients diagnosed with any other cause of glaucoma (congenital, pigmentary, inflammatory, closed-angle, etc.).
-Patients with aphakia, pseudoaphakia with tearing of the posterior lens capsule, or anterior chamber intraocular lenses.
-Patients with a history of (or risk factors for) cystoid macular edema.
-Patients susceptible to iritis and/or uveitis.

Non-ocular exclusion criteria
-Patients with non-stabilized systemic disease during at least 6 months prior to the screening visit (uncontrolled arterial hypertension, thyroid gland dysfunction, uncontrolled autoimmune disorders, patients with inadequate metabolic control ? including blood glucose outside ranges), or which precludes correct performance of the tests.
-Patients receiving systemic treatment with drugs exerting antihypertensive effects (beta-blockers, corticosteroids, acetazolamide, etc.), or who have used such drugs in the 2 months before inclusion in the study.
-Patients with known hypersensitivity to any of the ingredients of the study product or to drug substances belonging to the same family as any of the ingredients of the study product or which are used in the exploratory examinations / procedures.
-Women who are pregnant or breastfeeding at the time of the inclusion visit.
-Patients with mental alterations preventing compliance with the requirements of the study.
-Patients who do not agree to report to the protocolized visits or who refuse to follow the instructions related to the study procedures as explained by the investigator.

Compliance / administrative exclusion criteria:
-Suspected or confirmed illegal drug abuse.
-Participation in this same study in the past or in another clinical study in the 30 days before the screening visit.
-Incapacity of the patient and/or relatives to understand the study procedures, and thus inability to give informed consent.
-Non-compliers, i.e., patients who fail to report to the follow-up visits or whose life style interferes with the protocol compliance.
-Patients under legal custody.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate and compare tear osmolarity after the use of preserved latanoprost and non-preserved latanoprost in the study subjects.;Secondary Objective: - To evaluate and compare the effect of both treatments on intraocular pressure.<br>- To evaluate the correlation between tear osmolarity and the results of the Ocular Surface Disease Index (OSDI) questionnaire.<br> - To evaluate the correlation between tear osmolarity and the clinical tests of dry eye.;Primary end point(s): -Evaluation of the osmolarity value of the tear film;Timepoint(s) of evaluation of this end point: To be done on D-15, D28 and D84.

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: -To be done on D-15, D28 and D84.<br>-To be done on D-15, D28 and D84.<br>-To be done on D-15, D28 and D84.<br>-To be done on D-15, D28 and D84.<br>-To be done on D-15, D28 and D84<br>-To be done on D28 and D84;Secondary end point(s): -Evaluation of the quality of life index measured from the Ocular Surface Disease Index (OSDI) <br>- Evaluation of the intraocular pressure values <br>- Evaluation of the Schirmer test without anesthesia .<br>- Evaluation of the tear breakup time (TBUT) values <br>- Evaluation of the results of corneal staining (Oxford scheme) .<br>- Evaluation of the treatment safety, determining and classifying simple and serious AE, related or not to the study treatment, which appear in the fellow eye. The percentage of these events will be the cumulative value on the visits , in both treatment groups.