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

Primary Purpose

Dry Eye Syndromes, Cataract

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Vis Glyc Neo
Physiological saline solution
Sponsored by
OPKO Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dry Eye Syndromes focused on measuring Dry eye, Cataract, Visual acuity, Quality of life, Eye drops, Dry eye symptomatology, N-acetylcarnosine, Vaccinium myrtillus, Chondroitin sulfate, Chondroitin sulphate, N-Acetylcharnosine

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Hospital Universitario 12 de Octubre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vis Glyc Neo

physiological saline solution

Arm Description

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

Physiological saline solution ALVITA is administered.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Visual Acuity Evaluation I
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.
Visual Acuity Evaluation II
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.
Visual Acuity Evaluation III
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.
Dry eye symptomatology Evaluation I
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.
Dry eye symptomatology Evaluation II
- 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.
Dry eye symptomatology Evaluation III
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.
Treatment adherence
Ask patients about the daily administration of the treatment according to the protocol.
Adverse events
Number of participants with Adverse events and types of adverse events.

Full Information

First Posted
August 13, 2019
Last Updated
March 19, 2021
Sponsor
OPKO Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04063644
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 30, 2019 (Actual)
Primary Completion Date
December 22, 2020 (Actual)
Study Completion Date
December 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OPKO Health, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single-blinded: The physician performing the recruiting will be different and cannot be related to the investigator evaluating the follow-up.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vis Glyc Neo
Arm Type
Experimental
Arm Description
Vis glyc eye drops is administered. Eye drops based on N-Acetylcoarnosine, Vaccinium myrtillus and Chondroitin sulfate
Arm Title
physiological saline solution
Arm Type
Active Comparator
Arm Description
Physiological saline solution ALVITA is administered.
Intervention Type
Device
Intervention Name(s)
Vis Glyc Neo
Intervention Description
1 drop in each eye, three times a day.
Intervention Type
Device
Intervention Name(s)
Physiological saline solution
Intervention Description
1 drop in each eye, three times a day.
Primary Outcome Measure Information:
Title
Change in quality of visual life: NEI VFQ-25 questionnaire
Description
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.
Time Frame
Change from baseline quality of life at 6 months
Secondary Outcome Measure Information:
Title
Change in quality of visual life: NEI VFQ-25 questionnaire
Description
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.
Time Frame
0, 30, 90, 180 days
Title
Visual Acuity Evaluation I
Description
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.
Time Frame
0, 90, 180 days
Title
Visual Acuity Evaluation II
Description
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.
Time Frame
0, 90, 180 days
Title
Visual Acuity Evaluation III
Description
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.
Time Frame
0, 90, 180 days
Title
Dry eye symptomatology Evaluation I
Description
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.
Time Frame
0, 90, 180 days
Title
Dry eye symptomatology Evaluation II
Description
- 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.
Time Frame
0, 90, 180 days
Title
Dry eye symptomatology Evaluation III
Description
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.
Time Frame
0 and 180 days
Title
Treatment adherence
Description
Ask patients about the daily administration of the treatment according to the protocol.
Time Frame
30, 90 and 180 days
Title
Adverse events
Description
Number of participants with Adverse events and types of adverse events.
Time Frame
30, 90 and 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatriz Sarmiento Torres, MD, MSc
Organizational Affiliation
Hospital Universitario 12 Octubre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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

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