Dry EyeNCT07097922
Compare the Clinical Efficacy of 3% Diquafosol and 0.1% Hyaluronic Acid in Patients With Dry Eye After LASIK
A study testing 3% Diquafosol Sodium Eye Drops and 0.1% hyaluronic acid in people with Dry Eye, run by He Eye Hospital.
Trial summary
The prevalence of refractive ametropia is rising year by year. Refractive surgery has become the main approach for adults to correct refractive ametropia, and postoperative complications have aroused extensive attention from clinicians. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- 3% Diquafosol Sodium Eye Drops and 0.1% hyaluronic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- History of LASIK surgery for more than six months
- Confirmed dry eye: patients complained of one of the subjective symptoms of ocular dryness, foreign body sensation, burning sensation, fatigue, discomfort, redness of the eyes, and fluctuating visual acuity; as well as (a) OSDI questionnaire score of ≥13 and (b) non-invasive tear break-up time (NITBUT) of <10 s or (c) ocular surface staining assessed in >5 corneal patches/greater than 9 conjunctival patches
- Participants were able to co-operate with the use of eye drops as required, complete the examination, and return to the hospital within the specified time for follow-up examinations to complete the follow-up visit.
Who cannot join
- Suspected of having keratoconus, a definite diagnosis of keratoconus or another type of corneal dilatation disease.
- There is active inflammation or symptoms of infection in the eye
- There are serious lesions in the accessory structures of the eye, such as defects or deformations of the eyelids
- Patients with Connective tissue diseases and Autoimmune disorders (e.g., SLE, RA)
About this study
The prevalence of refractive ametropia is rising year by year. Refractive surgery has become the main approach for adults to correct refractive ametropia, and postoperative complications have aroused extensive attention from clinicians. Dry eye after refractive surgery is one of the postoperative complications, which is an important cause of affecting the postoperative visual quality and satisfaction of patients. It was reported that 3% diquafosol (DQS) and 0.1% hyaluronic acid (HA) can relieve dry eye symptoms. This study aims to compare the efficacy of 3% DQS and 0.1% HA in treating dry eye after LASIK
Read the detailed description
The development of corneal refractive surgery is rapid, but the complications are still inevitable; postoperative dry eye is one of them. Dry eye after refractive surgery will affect not only the patient's postoperative satisfaction but also the patient's postoperative visual quality, resulting in blurred vision, not lasting vision, and other problems. The occurrence of postoperative dry eye is mainly due to using anesthetics during operation; corneal nerve injury and cell apoptosis; changes in corneal curvature; postoperative medication, and so on. The patient's bad living habits may aggravate the degree of postoperative dry eye.
Diquafosol sodium is a P2Y2 receptor agonist. P2Y2 receptors are present on conjunctival and corneal epithelial cells, among others, on the ocular surface. When diquafosol sodium is used, it can activate P2Y2 receptors on these cells. This activation triggers the opening of intracellular signaling pathways that stimulate tear secretion. Normal tear secretion is important for corneal nerve repair because tears contain a variety of nutrients and growth factors. In the state of dry eye, the inflammatory factors on the ocular surface increase, and the stability of the tear film decreases. Diquafosol sodium can help to restore the stability of tear film by promoting tear secretion. A stable tear film reduces corneal nerve stimulation by inflammatory factors on the ocular surface. A large area of corneal nerves is injured during LASIK surgery, and no study has shown that diquafosol sodium has a role in nerve recovery after LASIK Hyaluronic acid (HA) lubricates, relieving dry eyes, astringent eyes, and eye fatigue. It can also flush and dilute inflammatory mediators on the ocular surface, reduce tear osmotic pressure, promote ocular surface epithelial healing, and promote ocular surface fibronectin secretion and deposition.
This study aims to compare the efficacy of 3% diquafosol and 0.1% hyaluronic acid in treating dry eye after LASIK. The observation of changes in corneal nerves and immune-inflammatory cells was added, aiming to observe the repair effect of diquafosol sodium on corneal nerves
- Conditions
- Dry Eye
- Being tested
- 3% Diquafosol Sodium Eye Drops, 0.1% hyaluronic acid
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% Diquafosol Sodium Eye DropsDrug
3% Diquafosol Sodium Eye Drops were instilled into the inferior conjunctival vault of both eyes
0.1% hyaluronic acidDrug
0.1% sodium hyaluronate eye drops were instillation into the inferior conjunctival vault of both eyes
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | dry eye patients after LASIK Receives: Drug: 3% Diquafosol Sodium Eye Drops |
| Control group | Other | dry eye patients after LASIK Receives: Drug: 0.1% hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-invasive tear break-up time (NITBUT)
The Keratograph 5M (Oculus, Germany) topographer will assess non-invasive tear breakup time. Three sequential readings will be captured, and the median value will be included in the final analysis. The median value will be recorded
Measured: Baseline, week 4, week 12 and week 24
Secondary outcomes (9)
Conjunctivocorneal staining (CS)
Fluorescein and lissamine staining of the ocular surface will be divided into three zones comprising nasal conjunctival, corneal, and temporal conjunctival areas. The staining score ranged from 0 to 3 for each zone, yielding a total score of 0-9 for the ocular surface
Measured: Baseline, week 4, week 12 and week 24
Tear film lipid layer (TFLL) score
Tear film lipid layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan). The results will be graded as follows: grade 1, somewhat gray color, uniform distribution; grade 2, somewhat gray color, nonuniform distribution; grade 3, a few colors, nonuniform distribution; grade 4, many colors, nonuniform distribution; grade 5, corneal surface partially exposed
Measured: Baseline, week 4, week 12 and week 24
Corneal Sensitivity Score
Corneal sensitivity score measured with a Cochet-Bonnet esthesiometer (in mm filament length); the measurements will be done 3 times at every assessment session, and the median value will be recorded.
Measured: Baseline, week 4, week 12 and week 24
Tear meniscus height (TMH)
Tear meniscus height using the Keratograph 5M (Oculus, Germany) topographer will be measured three times consecutively, and the median value will be recorded.
Measured: Baseline, week 4, week 12 and week 24
Conjunctival hyperemia (RS score)
Conjunctival hyperemia (RS score) will be assessed by a keratograph image (Oculus, Germany) of 1156 × 873 pixels, with a redness score (RS) ranging from 0.0 (normal) to 4.0 (severe).
Measured: Baseline, week 4, week 12 and week 24
Meibomian quality
Meibomian quality will be assessed under a slit-lamp; eight meibomian glands in the middle parts of the eyelid will be assessed using a scale of 0 to 3 for each gland (0 represented clear meibum; 1 represented cloudy meibum; 2 represented cloudy and granular meibum; and 3 represented thick, toothpaste-like consistency meibum).
Measured: Baseline, week 4, week 12 and week 24
Meibomian gland expressibility
Meibomian gland expression: five meibomian glands in the middle part were evaluated on a scale of 0-3: 0, all glandsexpressible; 1, 3-4 glands expressible; 2, 1-2 glands expressible; and 3, no glands expressible
Measured: Baseline, week 4, week 12 and week 24
Corneal nerves and immune/inflammatory cell change
HRT III RCM (Heidelberg Engineering GmbH, Germany) will be used to record corneal nerves and immune/ inflammatory cell change. It can accurately scan the cornea from the upper cortex to the inner cortex and other different depth levels and accurately judge the specific level and scope of the lesion. Three representative images of the subbasal nerve plexus and epithelial DCs will be selected for analysis for each eye, considering criteria such as a whole image in the same layer, best focus, and good contrast.
Measured: Baseline, week 4, week 12 and week 24
OSDI
The Ocular Surface Disease Index (OSDI) is a tool used to assess the degree to which ocular surface disease affects a patient's visual function and related symptoms. It is a subjective, patient-self-reported questionnaire.The questionnaire mainly covers three functions, and eye irritation symptoms. There are usually 12 questions, and the answer options for each question usually include "none," "mild," "moderate," and "severe," and the corresponding scores are 0, 1, 2, and 3. A range of 0-12 is classified as normal or mild symptoms. A range of 13-22 is classified as moderate symptoms. 23-36 is classified as severe symptoms.
Measured: Baseline, week 4, week 12 and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- He Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097922
- Sponsor's protocol ID
- LASIK2025
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 1 Aug 2025
- 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 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Clinical Efficacy of 3% Diquafosol and 0.1% Hyaluronic Acid in Patients With Dry Eye After LASIK
- ClinicalTrials.gov ID
- NCT07097922
- Acronym / sponsor ID
- LASIK2025
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- He Eye HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 1 Aug 2025 (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.
The prevalence of refractive ametropia is rising year by year. Refractive surgery has become the main approach for adults to correct refractive ametropia, and postoperative complications have aroused extensive attention from clinicians. Dry eye after refractive surgery is one of the postoperative complications, which is an important cause of affecting the postoperative visual quality and satisfaction of patients. It was reported that 3% diquafosol (DQS) and 0.1% hyaluronic acid (HA) can relieve dry eye symptoms. This study aims to compare the efficacy of 3% DQS and 0.1% HA in treating dry eye after LASIK
Detailed description
The development of corneal refractive surgery is rapid, but the complications are still inevitable; postoperative dry eye is one of them. Dry eye after refractive surgery will affect not only the patient's postoperative satisfaction but also the patient's postoperative visual quality, resulting in blurred vision, not lasting vision, and other problems. The occurrence of postoperative dry eye is mainly due to using anesthetics during operation; corneal nerve injury and cell apoptosis; changes in corneal curvature; postoperative medication, and so on. The patient's bad living habits may aggravate the degree of postoperative dry eye.
Diquafosol sodium is a P2Y2 receptor agonist. P2Y2 receptors are present on conjunctival and corneal epithelial cells, among others, on the ocular surface. When diquafosol sodium is used, it can activate P2Y2 receptors on these cells. This activation triggers the opening of intracellular signaling pathways that stimulate tear secretion. Normal tear secretion is important for corneal nerve repair because tears contain a variety of nutrients and growth factors. In the state of dry eye, the inflammatory factors on the ocular surface increase, and the stability of the tear film decreases. Diquafosol sodium can help to restore the stability of tear film by promoting tear secretion. A stable tear film reduces corneal nerve stimulation by inflammatory factors on the ocular surface. A large area of corneal nerves is injured during LASIK surgery, and no study has shown that diquafosol sodium has a role in nerve recovery after LASIK Hyaluronic acid (HA) lubricates, relieving dry eyes, astringent eyes, and eye fatigue. It can also flush and dilute inflammatory mediators on the ocular surface, reduce tear osmotic pressure, promote ocular surface epithelial healing, and promote ocular surface fibronectin secretion and deposition.
This study aims to compare the efficacy of 3% diquafosol and 0.1% hyaluronic acid in treating dry eye after LASIK. The observation of changes in corneal nerves and immune-inflammatory cells was added, aiming to observe the repair effect of diquafosol sodium on corneal nerves
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: 3% Diquafosol Sodium Eye Dropsdry eye patients after LASIK |
| Control group | Other | Drug: 0.1% hyaluronic aciddry eye patients after LASIK |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- History of LASIK surgery for more than six months
- Confirmed dry eye: patients complained of one of the subjective symptoms of ocular dryness, foreign body sensation, burning sensation, fatigue, discomfort, redness of the eyes, and fluctuating visual acuity; as well as (a) OSDI questionnaire score of ≥13 and (b) non-invasive tear break-up time (NITBUT) of <10 s or (c) ocular surface staining assessed in >5 corneal patches/greater than 9 conjunctival patches
- Participants were able to co-operate with the use of eye drops as required, complete the examination, and return to the hospital within the specified time for follow-up examinations to complete the follow-up visit.
Key exclusion criteria (4 listed)
- Suspected of having keratoconus, a definite diagnosis of keratoconus or another type of corneal dilatation disease.
- There is active inflammation or symptoms of infection in the eye
- There are serious lesions in the accessory structures of the eye, such as defects or deformations of the eyelids
- Patients with Connective tissue diseases and Autoimmune disorders (e.g., SLE, RA)
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 |
|---|---|---|
| 3% Diquafosol Sodium Eye Drops3% Diquafosol Sodium Eye Drops were instilled into the inferior conjunctival vault of both eyes | Drug | Study group |
| 0.1% hyaluronic acid0.1% sodium hyaluronate eye drops were instillation into the inferior conjunctival vault of both eyes | Drug | Control group |
Primary outcome
Non-invasive tear break-up time (NITBUT)
Time frame: Baseline, week 4, week 12 and week 24
The Keratograph 5M (Oculus, Germany) topographer will assess non-invasive tear breakup time. Three sequential readings will be captured, and the median value will be included in the final analysis. The median value will be recorded
9 secondary outcomes
Conjunctivocorneal staining (CS)
Time frame: Baseline, week 4, week 12 and week 24
Tear film lipid layer (TFLL) score
Time frame: Baseline, week 4, week 12 and week 24
Corneal Sensitivity Score
Time frame: Baseline, week 4, week 12 and week 24
Tear meniscus height (TMH)
Time frame: Baseline, week 4, week 12 and week 24
Conjunctival hyperemia (RS score)
Time frame: Baseline, week 4, week 12 and week 24
Meibomian quality
Time frame: Baseline, week 4, week 12 and week 24
Meibomian gland expressibility
Time frame: Baseline, week 4, week 12 and week 24
Corneal nerves and immune/inflammatory cell change
Time frame: Baseline, week 4, week 12 and week 24
OSDI
Time frame: Baseline, week 4, week 12 and week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 3% Diquafosol Sodium Eye Drops and 0.1% hyaluronic acid in people with Dry Eye, run by He Eye Hospital.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Non-invasive tear break-up time (NITBUT) (time frame: Baseline, week 4, week 12 and week 24). 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 Aug 2025.