NCT04063644 - Quality of Life and Visual Acuity of Visglyc Eye Drops on Dry Eye Patients | Crick

Overview

Clinical trial with medical devices, post-authorization, parallel, single-blind, randomized, comparative, prospective to study how afects the quality of life the use of ocular eye drops on patients with dry eye symptomatology and age-related loss of visual acuity. Secondary purposes: efects on the dry eye symptomatology, efect on visual acuity and treatment adherence.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

100

Conditions

Dry Eye Syndromes Cataract

Interventions

Vis Glyc NeoDEVICE

1 drop in each eye, three times a day.

Physiological saline solutionDEVICE

1 drop in each eye, three times a day.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects between the ages of 50 and 70. * Subjects with initial or slight changes characteristic of cataracts (grade 1-3 according to LOCS III classification). * Subjects with dry eye symptoms. * Confirmation of senile cataract diagnosis according to medical history and clinical observations, bilateral. * Visual acuity equal to or greater than (0.6) in both eyes (with the best correction). * Cataracts without the need for surgical intervention in the near future (1 year) based on the visual needs of the patient and ocular symptomatology. * Subjects that have not undergone cataract surgery. * Cases that do not accept surgery (weak corneas, high degree of myopia, sensitivity to light, severe dryness of the eyes or by their own decision). * Subjects who agree to sign the IC (Informed Consent). Exclusion Criteria: * Subjects with eye diseases such as glaucoma or diabetic retinopathy. * Previous laser photocoagulation of the retina. * Previous corneal or anterior segment surgery or previous corneal scars that may interfere with visualization or photographs. * Presence of mature cataracts (grade 4-5/6 according to LOCS III classification) in both eyes. * Candidates for surgery in the following year. * Subjects with monocular aphakia (absence of crystalline lens) or secondary cataracts (associated with steroid use, local or total irradiation, local inflammation or degenerative processes, ocular trauma). * Subjects with known hypersensitivity to any component of ophthalmic treatment. * Subjects treated with drugs that may interfere with the evolution of the disease under study. * Subjects who wear contact lenses. * Pregnant women. * Breastfeeding women. * Subjects who have participated in another clinical trial within the last 30 days. * Subjects with linguistic or psychological incapacity to understand and sign the CI.

Locations (1)

Hospital Universitario 12 de Octubre

Madrid, Spain

Outcomes

Primary Outcomes

Change in quality of visual life: NEI VFQ-25 questionnaire

In patients with dry eye symptomatology and age-related loss of visual acuity. Assessed using NEI VFQ-25 questionnaire. It is a questionnaire with 25 questions. Its format is divided into 4 subscales: visual function, difficulty with activities, driving a car and responding to vision problems. It consists of a base of 25 questions (each with five or six levels of response and scoring ranges) addressed to vision, representing 11 domains, elements or items related to health; 1) general vision, 2) eye pain, 3) near activities, 4) distance activities, 5) social functioning, 6) mental health, 7) role difficulties or limitations, 8) dependence, 9) driving, 10) color vision and 11) peripheral vision. Each domain receives an evaluation from 0 to 100; the high evaluation represents changes in visual functioning, where 0 is the lowest and 100 is the best possible.

Time frame: Change from baseline quality of life at 6 months

Secondary Outcomes

Change in quality of visual life: NEI VFQ-25 questionnaire

In patients with dry eye symptomatology and age-related loss of visual acuity. Assessed using NEI VFQ-25 questionnaire. It is a questionnaire with 25 questions. Its format is divided into 4 subscales: visual function, difficulty with activities, driving a car and responding to vision problems. It consists of a base of 25 questions (each with five or six levels of response and scoring ranges) addressed to vision, representing 11 domains, elements or items related to health; 1) general vision, 2) eye pain, 3) near activities, 4) distance activities, 5) social functioning, 6) mental health, 7) role difficulties or limitations, 8) dependence, 9) driving, 10) color vision and 11) peripheral vision. Each domain receives an evaluation from 0 to 100; the high evaluation represents changes in visual functioning, where 0 is the lowest and 100 is the best possible.

Time frame: 0, 30, 90, 180 days

Visual Acuity Evaluation I

To assess the age-related visual acuity in patients. \- The CSV-1000E contrast sensitivity test. This test provides for four (4) rows of sine-wave gratings. These gratings test the spatial frequencies of 3, 6, 12 and 18 cycles/degree (CPD). The levels of contrast are 1 to 8. The higher the contrast or modulation, the greater the difference in luminance and the better the object will be distinguished from the background.