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

OPKO Health

Status

Completed

Conditions

Cataract

Dry Eye Syndromes

Treatments

Device: Vis Glyc Neo

Device: Physiological saline solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT04063644

OPK-GLY-2018-01

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

50 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.