Dry Eye SyndromesNCT04063644
Quality of Life and Visual Acuity of Visglyc Eye Drops on Dry Eye Patients
A study testing Vis Glyc Neo and Physiological saline solution in people with Dry Eye Syndromes and Cataract, run by OPKO Health, Inc. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes, Cataract
- What is being tested?
- Vis Glyc Neo and Physiological saline solution
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 30 May 2019to 22 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Visglyc on the Quality of Life of Patients With Dry Eye Symptomatology and Age-related Loss of Visual Acuity
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
- Being tested
- Vis Glyc Neo, Physiological saline solution
- Keywords
- Dry eye, Cataract, Visual acuity, Quality of life, Eye drops, Dry eye symptomatology, N-acetylcarnosine, Vaccinium myrtillus, Chondroitin sulfate, Chondroitin sulphate, N-Acetylcharnosine
- Medical subject headings
- Dry Eye Syndromes, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vis Glyc NeoDevice
1 drop in each eye, three times a day.
Physiological saline solutionDevice
1 drop in each eye, three times a day.
| Study group | Role | What they receive |
|---|---|---|
| Vis Glyc Neo | Experimental | Vis glyc eye drops is administered.
Eye drops based on N-Acetylcoarnosine, Vaccinium myrtillus and Chondroitin sulfate Receives: Device: Vis Glyc Neo |
| physiological saline solution | Active comparator | Physiological saline solution ALVITA is administered. Receives: Device: Physiological saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline quality of life at 6 months
Secondary outcomes (9)
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.
Measured: 0, 30, 90, 180 days
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.
Measured: 0, 90, 180 days
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.
Measured: 0, 90, 180 days
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.
Measured: 0, 90, 180 days
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.
Measured: 0, 90, 180 days
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.
Measured: 0, 90, 180 days
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.
Measured: 0 and 180 days
Treatment adherence
Ask patients about the daily administration of the treatment according to the protocol.
Measured: 30, 90 and 180 days
Adverse events
Number of participants with Adverse events and types of adverse events.
Measured: 30, 90 and 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start30 May 2019
- Primary completion22 Dec 2020
- Study completion22 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beatriz Sarmiento Torres, MD, MSc, Principal investigator, Hospital Universitario 12 Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063644
- Sponsor's protocol ID
- OPK-GLY-2018-01
- Status last verified
- Mar 2021
- First submitted
- 13 Aug 2019
- Last updated
- 23 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Visglyc on the Quality of Life of Patients With Dry Eye Symptomatology and Age-related Loss of Visual Acuity
- ClinicalTrials.gov ID
- NCT04063644
- Acronym / sponsor ID
- OPK-GLY-2018-01
- Conditions
- Dry Eye Syndromes, Cataract
- Keywords
- Dry eye, Cataract, Visual acuity, Quality of life, Eye drops, Dry eye symptomatology, N-acetylcarnosine, Vaccinium myrtillus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 May 2019 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vis Glyc Neo | Experimental | Device: Vis Glyc NeoVis glyc eye drops is administered. Eye drops based on N-Acetylcoarnosine, Vaccinium myrtillus and Chondroitin sulfate |
| physiological saline solution | Active comparator | Device: Physiological saline solutionPhysiological saline solution ALVITA is administered. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vis Glyc Neo1 drop in each eye, three times a day. | Device | Vis Glyc Neo |
| Physiological saline solution1 drop in each eye, three times a day. | Device | physiological saline solution |
Primary outcome
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.
9 secondary outcomes
Change in quality of visual life: NEI VFQ-25 questionnaire
Time frame: 0, 30, 90, 180 days
Visual Acuity Evaluation I
Time frame: 0, 90, 180 days
Visual Acuity Evaluation II
Time frame: 0, 90, 180 days
Visual Acuity Evaluation III
Time frame: 0, 90, 180 days
Dry eye symptomatology Evaluation I
Time frame: 0, 90, 180 days
Dry eye symptomatology Evaluation II
Time frame: 0, 90, 180 days
Dry eye symptomatology Evaluation III
Time frame: 0 and 180 days
Treatment adherence
Time frame: 30, 90 and 180 days
Adverse events
Time frame: 30, 90 and 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatriz Sarmiento Torres, MD, MSc principal investigator
Hospital Universitario 12 Octubre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vis Glyc Neo and Physiological saline solution in people with Dry Eye Syndromes and Cataract, run by OPKO Health, Inc. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of visual life: NEI VFQ-25 questionnaire (time frame: Change from baseline quality of life at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.