Clinical trial NCT04063644: Quality of Life and Visual Acuity of Visglyc Eye Drops on Dry Eye Patients
Official title: Effect of Visglyc on the Quality of Life of Patients With Dry Eye Symptomatology and Age-related Loss of Visual Acuity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-21
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Change in quality of visual life: NEI VFQ-25 questionnaire
timeFrame: Change from baseline quality of life at 6 months
Secondary outcomes:
measure: Change in quality of visual life: NEI VFQ-25 questionnaire
timeFrame: 0, 30, 90, 180 days
measure: Visual Acuity Evaluation I
timeFrame: 0, 90, 180 days
measure: Visual Acuity Evaluation II
timeFrame: 0, 90, 180 days
measure: Visual Acuity Evaluation III
timeFrame: 0, 90, 180 days
measure: Dry eye symptomatology Evaluation I
timeFrame: 0, 90, 180 days
measure: Dry eye symptomatology Evaluation II
timeFrame: 0, 90, 180 days
measure: Dry eye symptomatology Evaluation III
timeFrame: 0 and 180 days
measure: Treatment adherence
timeFrame: 30, 90 and 180 days
measure: Adverse events
timeFrame: 30, 90 and 180 days
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Hospital Universitario 12 Octubre
name: Beatriz Sarmiento Torres, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: