Quality of Life and Visual Acuity of Visglyc Eye Drops on Dry Eye Patients

NCT04063644 | Completed

• 1 other identifier: OPK-GLY-2018-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndromes; Cataract

Keywords

Dry eye; Cataract; Visual acuity; Quality of life; Eye drops; Dry eye symptomatology; N-acetylcarnosine; Vaccinium myrtillus; Chondroitin sulfate; Chondroitin sulphate; N-Acetylcharnosine

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline quality of life at 6 months

Secondary Outcomes (9)

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

  0, 30, 90, 180 days

• Visual Acuity Evaluation I

  0, 90, 180 days

• Visual Acuity Evaluation II

  0, 90, 180 days

• Visual Acuity Evaluation III

  0, 90, 180 days

• Dry eye symptomatology Evaluation I

  0, 90, 180 days

Study Arms (2)

Vis Glyc Neo

EXPERIMENTAL

Vis glyc eye drops is administered. Eye drops based on N-Acetylcoarnosine, Vaccinium myrtillus and Chondroitin sulfate

Device: Vis Glyc Neo

physiological saline solution

ACTIVE COMPARATOR

Physiological saline solution ALVITA is administered.

Device: Physiological saline solution

Interventions

Vis Glyc Neo DEVICE

1 drop in each eye, three times a day.

Vis Glyc Neo

Physiological saline solution DEVICE

1 drop in each eye, three times a day.

physiological saline solution

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• OPKO Health, Inc.: lead

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Cataract

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Lens Diseases

Study Officials

• Beatriz Sarmiento Torres, MD, MSc

  Hospital Universitario 12 Octubre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blinded: The physician performing the recruiting will be different and cannot be related to the investigator evaluating the follow-up.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 21, 2019
• Study Start: May 30, 2019
• Primary Completion: December 22, 2020
• Study Completion: December 22, 2020
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)