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

NCT ID: NCT04063644

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-30
• Study Completion Date: 2020-12-22

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Vis Glyc Neo

Vis glyc eye drops is administered.

Eye drops based on N-Acetylcoarnosine, Vaccinium myrtillus and Chondroitin sulfate

Group Type: EXPERIMENTAL

Vis Glyc Neo

Intervention Type: DEVICE

1 drop in each eye, three times a day.

physiological saline solution

Physiological saline solution ALVITA is administered.

Group Type: ACTIVE_COMPARATOR

Physiological saline solution

Intervention Type: DEVICE

1 drop in each eye, three times a day.

Interventions

Vis Glyc Neo

1 drop in each eye, three times a day.

Intervention Type: DEVICE

Physiological saline solution

1 drop in each eye, three times a day.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

OPKO Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beatriz Sarmiento Torres, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario 12 Octubre

Locations

Hospital Universitario 12 de Octubre

Madrid, , Spain

Countries

Spain

Other Identifiers

OPK-GLY-2018-01

Identifier Type: -

Identifier Source: org_study_id