Dry Eye SyndromesPhase 4NCT04668118
The Effect of 3% Diquafosol Ophthalmic Solution on Visual Display Terminal-associated Dry Eye
A Phase 4 study testing Diquafosol in people with Dry Eye Syndromes and Computer Vision Syndrome, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of 3% Diquafosol Ophthalmic Solution for visual display terminal (VDT)-associated dry eye and to investigate the mechanism of treatment. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Dry Eye Syndromes, Computer Vision Syndrome, Asthenopia
- What is being tested?
- Diquafosol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 25 Mar 2023
- Phase
- Phase 4
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female with a diagnosis dry eye based on Chinese Dry Eye Diagnosis Standard (2020)；
- Working in the offices with VDTs more than 4h daily；
- Working in the offices with VDTs at least five days per week；
- Provision of written informed consent.
Who cannot join
- Known allergy to any eye drops
- Ocular therapies other than artificial tears
- Presence of any of the following conditions: active ocular infection, ocular inflammation, active ocular allergy, contact lens wear, ocular surgical history, laser treatment in the last 3 months, Meibomian gland dysfunction (MGD) over grade 2 (the grade is according to the report of the International Workshop on MGD in 2011), severe blepharitis or obvious inflammation of the eyelid margin, which in the judgment of the investigator may interfere with the interpretation of the study results
- Pregnant and lactating women, or those planning a pregnancy over the course of the study
- Uncontrolled systemic disease
- Hypersensitivity or intolerance to diquafosol(DQS)
- Subjects with a history of anxiety and depression
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Hong Qi, MD, doctorqihong@163.com
About this study
This study aims to evaluate the efficacy and safety of 3% Diquafosol Ophthalmic Solution for visual display terminal (VDT)-associated dry eye and to investigate the mechanism of treatment.
Read the detailed description
The treatment period is 12 weeks. The day after subjects who meet the inclusion criteria undergo baseline examination is the day starting the medication. The dosing frequency was six times daily for 3% Diquafosol Ophthalmic Solution. The follow-up time points are 2, 4, 8, 12 weeks, and the investigator will evaluate the symptoms and signs of Dry Eye.
- Conditions
- Dry Eye Syndromes, Computer Vision Syndrome, Asthenopia
- Being tested
- Diquafosol
- Medical subject headings
- Dry Eye Syndromes, Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiquafosolDrug
Also called Diquafosol Sodium Eye Drops, 3% Diquafosol Ophthalmic Solution
As a P2Y2 receptor agonist, diquafosol can be used to stabilize the tear film by stimulating P2Y2 receptors on the corneal epithelial cells and conjunctival goblet cell, which increase the secretion of tear fluid and mucin on the ocular surface, thereby repairing the ocular surface and stabilizing the tear film.
| Study group | Role | What they receive |
|---|---|---|
| Diquafosol group | Experimental | The treatment period is 12 weeks. The day after subjects who meet the inclusion criteria undergo baseline examination is the day starting the medication. Dosing frequency was six times daily for 3% Diquafosol Ophthalmic Solution. The follow-up time points are 2, 4, 8, 12 weeks, and no other medication is required on the follow-up day. Receives: Drug: Diquafosol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the changes of Ocular Surface Disease Index (OSDI) scores
OSDI is one of the most frequently used questionnaires for evaluation of Dry eye disease(DED). This includes 12 questions which measure the frequency of symptoms over the recent week, and the scores range from 0 to 100. The higher the score, the worse the result.
Measured: 12 weeks after intervention
the changes of Tear break-up time (TBUT)
TBUT is the time from normal blinking to the first appearance of a break in the tear film. The BUT was measured using fluorescein with a metronome, and the average of three consecutive BUTs was calculated. The shorter the TBUT, the worse the outcome.
Measured: 12 weeks after intervention
Secondary outcomes (5)
the changes of scores of Corneal fluorescein staining (CFS)
The degree of fluorescein staining of the cornea was evaluated using the National Eye Institute (NEI) scale of five corneal regions (central, superior, temporal, nasal, and inferior). The degree of staining in each of the five regions was graded on a scale of 0-3 according to the NEI/Industry Workshop method: 0 =no staining, 1 =mild staining, 2 = moderate staining, and 3 = severe staining. The maximal score for each area was 3. The scores of the five areas were added to obtain a total score for each eye. The higher the score, the worse the result.
Measured: 12 weeks after intervention
the changes of scores of Lissamine green staining
To grade the temporal zone, the subject looks nasally; to grade the nasal zone the subject looks temporally. The upper and lower conjunctiva can also be graded. The higher the score, the worse the result.
Measured: 12 weeks after intervention
the changes of value of Schirmer Ⅰ test (SⅠt)
The Schirmer I test is performed using sterile strips without anesthesia. The strips are placed in the lateral part of the inferior fornix of the eye for 5min and the extent of tear flow down was measured in millimeters. The higher the value, the better the result.
Measured: 12 weeks after intervention
the changes of Lipid layer thickness(LLT)
Lipid layer is evaluated by Lipiview interferometer (TearScience Inc, Morrisville, NC, USA) which records a 15-s live digital image of the interference pattern of the tear film. The interferometry color units (ICU) of the tear film which is an indicator of lipid layer thickness is assessed according to the mean interference color pattern through specular reflection. The higher the thickness, the better the result.
Measured: 12 weeks after intervention
the changes of Partial blink rate(PBR)
PBR can be provided by Lipiview interferometer, which mainly evaluate incomplete blinking. The higher the rate, the worse the result.
Measured: 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start1 Feb 2021
- Primary completion1 Oct 2022 (estimated)
- Study completion25 Mar 2023 (estimated)
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.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tingting Yang, MD, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668118
- Sponsor's protocol ID
- Diquafosol
- Status last verified
- Apr 2022
- First submitted
- 6 Dec 2020
- Last updated
- 1 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 3% Diquafosol Ophthalmic Solution on Visual Display Terminal-associated Dry Eye
- ClinicalTrials.gov ID
- NCT04668118
- Acronym / sponsor ID
- Diquafosol
- Conditions
- Dry Eye Syndromes, Computer Vision Syndrome, Asthenopia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 25 Mar 2023 (estimated)
- First posted
- 16 Dec 2020 (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.
This study aims to evaluate the efficacy and safety of 3% Diquafosol Ophthalmic Solution for visual display terminal (VDT)-associated dry eye and to investigate the mechanism of treatment.
Detailed description
The treatment period is 12 weeks. The day after subjects who meet the inclusion criteria undergo baseline examination is the day starting the medication. The dosing frequency was six times daily for 3% Diquafosol Ophthalmic Solution. The follow-up time points are 2, 4, 8, 12 weeks, and the investigator will evaluate the symptoms and signs of Dry Eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diquafosol group | Experimental | Drug: DiquafosolThe treatment period is 12 weeks. The day after subjects who meet the inclusion criteria undergo baseline examination is the day starting the medication. Dosing frequency was six times daily for 3% Diquafosol Ophthalmic Solution. The follow-up time points are 2, 4, 8, 12 weeks, and no other medication is required on the follow-up day. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female with a diagnosis dry eye based on Chinese Dry Eye Diagnosis Standard (2020)；
- Working in the offices with VDTs more than 4h daily；
- Working in the offices with VDTs at least five days per week；
- Provision of written informed consent.
Key exclusion criteria (7 listed)
- Known allergy to any eye drops
- Ocular therapies other than artificial tears
- Presence of any of the following conditions: active ocular infection, ocular inflammation, active ocular allergy, contact lens wear, ocular surgical history, laser treatment in the last 3 months, Meibomian gland dysfunction (MGD) over grade 2 (the grade is according to the report of the International Workshop on MGD in 2011), severe blepharitis or obvious inflammation of the eyelid margin, which in the judgment of the investigator may interfere with the interpretation of the study results
- Pregnant and lactating women, or those planning a pregnancy over the course of the study
- Uncontrolled systemic disease
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 |
|---|---|---|
| DiquafosolAlso: Diquafosol Sodium Eye Drops, 3% Diquafosol Ophthalmic SolutionAs a P2Y2 receptor agonist, diquafosol can be used to stabilize the tear film by stimulating P2Y2 receptors on the corneal epithelial cells and conjunctival goblet cell, which increase the secretion of tear fluid and mucin on the ocular surface, thereby repairing the ocular surface and stabilizing the tear film. | Drug | Diquafosol group |
Primary outcome
the changes of Ocular Surface Disease Index (OSDI) scores
Time frame: 12 weeks after intervention
OSDI is one of the most frequently used questionnaires for evaluation of Dry eye disease(DED). This includes 12 questions which measure the frequency of symptoms over the recent week, and the scores range from 0 to 100. The higher the score, the worse the result.
the changes of Tear break-up time (TBUT)
Time frame: 12 weeks after intervention
TBUT is the time from normal blinking to the first appearance of a break in the tear film. The BUT was measured using fluorescein with a metronome, and the average of three consecutive BUTs was calculated. The shorter the TBUT, the worse the outcome.
5 secondary outcomes
the changes of scores of Corneal fluorescein staining (CFS)
Time frame: 12 weeks after intervention
the changes of scores of Lissamine green staining
Time frame: 12 weeks after intervention
the changes of value of Schirmer Ⅰ test (SⅠt)
Time frame: 12 weeks after intervention
the changes of Lipid layer thickness(LLT)
Time frame: 12 weeks after intervention
the changes of Partial blink rate(PBR)
Time frame: 12 weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
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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.
Tingting Yang, MD study director
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diquafosol in people with Dry Eye Syndromes and Computer Vision Syndrome, run by Peking University Third Hospital at 1 site in China.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 Jun 2022. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Qi, Phd (010-13901066889, doctorqihong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the changes of Ocular Surface Disease Index (OSDI) scores (time frame: 12 weeks after intervention). The study lists 2 primary outcomes in all. 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 1 Jun 2022.