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Completed

NCT Number: NCT04063644

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

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.

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Key information

Conditions

Dry Eye Syndromes Cataract Eye Diseases Lacrimal Apparatus Diseases Lens Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vis Glyc Neo

Device

1 drop in each eye, three times a day.

Physiological saline solution

Device

1 drop in each eye, three times a day.

Primary outcomes

  1. 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

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

    Time frame: 0, 30, 90, 180 days

    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.

  2. Visual Acuity Evaluation I

    Time frame: 0, 90, 180 days

    To assess the age-related visual acuity in patients.

    • The CSV-1000E contrast sensitivity test. This test provides for four (4) rows of sine-wave gratings. These gratings test the spatial frequencies of 3, 6, 12 and 18 cycles/degree (CPD). The levels of contrast are 1 to 8. The higher the contrast or modulation, the greater the difference in luminance and the better the object will be distinguished from the background.

  3. Visual Acuity Evaluation II

    Time frame: 0, 90, 180 days

    To assess the age-related visual acuity in patients.

    • LOCS III classification of cataract grade using images obtained by ophthalmoscopy with slit lamp, which allows the study of the anterior segment of the patient's eye. It consists of six slit lamp images to evaluate core color (NC) and opalescence (NO); five backlit images to evaluate cortical cataract (C); and five backlit images to evaluate posterior subcapsular cataract (P). The severity of the cataract is classified on a decimal scale, and the patterns have regularly separated intervals on a decimal scale.

  4. Visual Acuity Evaluation III

    Time frame: 0, 90, 180 days

    To assess the age-related visual acuity in patients.

    • Visual acuity test with the best correction in each eye using Snellen E-screens, measured in decimal system and MAR logarithm. Level of vision with respect to the row in Snellen's graph, which the rows consist of 1 to 11. The lower the row (greater numbers) the patient can distinguish, the greater the visual acuity he will have.

  5. Dry eye symptomatology Evaluation I

    Time frame: 0, 90, 180 days

    Schirmer I test (without anesthesia): to determine the dryness of the eye. It consists of placing a thin strip of paper at the bottom of the conjunctival sac and before this foreign body see the patient's tear production capacity (measuring the wet area in mm). The less mm the less tear production capacity.

  6. Dry eye symptomatology Evaluation II

    Time frame: 0, 90, 180 days

    • Fluorescein staining test: to assess dryness of the eye. Fluorescein is instilled in both conjunctival sacs. Absence of staining indicates integrity of the corneal epithelium. There are degrees of fluorescein staining from 0 to 5. The highest the worst results.

  7. Dry eye symptomatology Evaluation III

    Time frame: 0 and 180 days

    The OSDI Test (ocular surface disease index) is a simple test created to establish the severity and classification of dry eye according to its symptoms. It is based on 12 different questions about situations related to patient symptomatology.

    A score of 100 corresponds to a total disability (answer "At all times" to all questions answered), while a score of 0 corresponds to no disability.

  8. Treatment adherence

    Time frame: 30, 90 and 180 days

    Ask patients about the daily administration of the treatment according to the protocol.

  9. Adverse events

    Time frame: 30, 90 and 180 days

    Number of participants with Adverse events and types of adverse events.

Sponsors and collaborators

Lead sponsor

OPKO Health, Inc.

Industry

Registry information

Official study title

Effect of Visglyc on the Quality of Life of Patients With Dry Eye Symptomatology and Age-related Loss of Visual Acuity

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 21, 2019
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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