Effect of Visglyc on the Quality of Life of Patients With Dry Eye Symptomatology and Age-related Loss of Visual Acuity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- OPKO Health, Inc.
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in quality of visual life: NEI VFQ-25 questionnaire
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
Single-blinded: The physician performing the recruiting will be different and cannot be related to the investigator evaluating the follow-up.
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects between the ages of 50 and
- •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.
Arms & Interventions
Vis Glyc Neo
Vis glyc eye drops is administered.
Eye drops based on N-Acetylcoarnosine, Vaccinium myrtillus and Chondroitin sulfate
Intervention: Vis Glyc Neo (Device)
physiological saline solution
Physiological saline solution ALVITA is administered.
Intervention: Physiological saline solution (Device)
Outcomes
Primary Outcomes
Change in quality of visual life: NEI VFQ-25 questionnaire
Time Frame: Change from baseline quality of life at 6 months
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.
Secondary Outcomes
- Dry eye symptomatology Evaluation I(0, 90, 180 days)
- Treatment adherence(30, 90 and 180 days)
- Change in quality of visual life: NEI VFQ-25 questionnaire(0, 30, 90, 180 days)
- Visual Acuity Evaluation III(0, 90, 180 days)
- Dry eye symptomatology Evaluation II(0, 90, 180 days)
- Adverse events(30, 90 and 180 days)
- Visual Acuity Evaluation II(0, 90, 180 days)
- Dry eye symptomatology Evaluation III(0 and 180 days)
- Visual Acuity Evaluation I(0, 90, 180 days)