Dry EyeNCT06852105
Compare the Clinical Efficacy of 3% Diquafosol and 0.1% Hyaluronic Acid in Patients with Dry Eye After Trans-PRK
A study testing 3% Diquafosol Sodium Eye Drops and 0.1% hyaluronic acid in people with Dry Eye and Tear Break-Up Time, 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, Tear Break-Up Time
- 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
- 76 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2025to 31 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
- Age 18-40 years.
- The refractive status should be maintained at least for more than 2 years, during which the annual increase in myopia should be controlled within 0.50 D.
- Pherical equivalent (SE) ≤-6.00D, astigmatic power≤-2.00D.
- Best corrected vision before surgery≥1.0.
- Patients should stop wearing soft contact lenses for at least 2 weeks and hard contact lenses for at least 4 weeks before surgery.
- Postoperative corneal stromal thickness was preserved (280 μm).
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.
- The thickness of the cornea does not meet the preset cutting depth requirement: the thickness of the central cornea should be greater than 450 μm, and the thickness of the central corneal stroma remaining under the corneal flap should be maintained above 250 μm after the intended cutting (280 μm recommended).
- Dry eye.
- There are serious lesions in the accessory structures of the eye, such as defects or deformations of the eyelids.
- People with uncontrolled systemic connective tissue diseases and autoimmune diseases, such as systemic lupus erythematosus and rheumatoid arthritis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
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 Trans-PRK
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 Trans-PRK surgery, and no study has shown that diquafosol sodium has a role in nerve recovery after Trans-PRK 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 Trans-PRK. The observation of changes in corneal nerves and immune-inflammatory cells was added, aiming to observe the repair effect of difossol sodium on corneal nerves.
- Conditions
- Dry Eye, Tear Break-Up Time
- Being tested
- 3% Diquafosol Sodium Eye Drops, 0.1% hyaluronic acid
- Keywords
- dry eye, Trans-PRK
- 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 | Other | dry eye patients after Trans-PRK Receives: Drug: 3% Diquafosol Sodium Eye Drops |
| Control group | Other | dry eye patients after Trans-PRK 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: day 1, week 1, 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: day 1, week 1, 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: day 1, week 1, 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: day 1, week 1, week 4, week 12 and week 24
Tear meniscus height (TMH)
Ear meniscus height using the Keratograph 5M (Oculus, Germany) topographer will be measured three times consecutively, and the median value will be recorded.
Measured: day 1, week 1, 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: day 1, week 1, 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: day 1, week 1, 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: 1 week, 12 weeks and 24 weeks after surgery.
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 aspects of eye discomfort, including eye pain or discomfort, vision-related dysfunction, 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: day 1, week 1, 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 glands expressible; 1, 3-4 glands expressible; 2, 1-2 glands expressible; and 3, no glands expressible.
Measured: day 1, week 1, 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 posted28 Feb 2025
- Study start28 Feb 2025 (estimated)
- Primary completion28 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 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
- NCT06852105
- Sponsor's protocol ID
- PRK2025
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zaabaar E, Asiamah R, Kyei S, Ankamah S. Myopia control strategies: A systematic review and meta-meta-analysis. Ophthalmic Physiol Opt. 2025 Jan;45(1):160-176. doi: 10.1111/opo.13417. Epub 2024 Nov 12.
PubMed 39530399Du Y, Di Y, Yang S, Li Y. Analysis of the changes in corneal optical density following small incision lenticule extraction for myopia and related influencing factors. Photodiagnosis Photodyn Ther. 2024 Dec;50:104397. doi: 10.1016/j.pdpdt.2024.104397. Epub 2024 Nov 9.
PubMed 39528007Mu J, Zhong H, Jiang M, Wang J, Zhang S. Development of a nomogram for predicting myopia risk among school-age children: a case-control study. Ann Med. 2024 Dec;56(1):2331056. doi: 10.1080/07853890.2024.2331056. Epub 2024 Mar 20.
PubMed 38507901Zhao L, Zhang Y, Duan H, Yang T, Ma B, Zhou Y, Chen J, Chen Y, Qi H. Clinical Characteristic and Tear Film Biomarkers After Myopic FS-LASIK: 1-Year Prospective Follow-up. J Refract Surg. 2024 Aug;40(8):e508-e519. doi: 10.3928/1081597X-20240514-05. Epub 2024 Sep 1.
PubMed 39120023Hou X, Chen P, Yu N, Luo Y, Wei H, Zhuang J, Yu K. A Comparative and Prospective Study of Corneal Consumption and Corneal Biomechanics After SMILE and FS-LASIK Performed on the Contralateral Eyes With High Myopic Astigmatism. Transl Vis Sci Technol. 2024 Nov 4;13(11):29. doi: 10.1167/tvst.13.11.29.
PubMed 39576656Yang F, Yang Z, Zhao S, Huang Y. To Investigate the Changes in Corneal Curvature and Its Correlation with Corneal Epithelial Remodeling After Trans-PRK and FS-LASIK. Curr Eye Res. 2024 Oct;49(10):1061-1067. doi: 10.1080/02713683.2024.2361728. Epub 2024 Jun 12.
PubMed 38867491Su B, Cho P, Vincent SJ, Zheng J, Chen J, Ye C, Wang T, Zhang J, Zhang K, Lu F, Jiang J. Novel Lenslet-ARray-Integrated Spectacle Lenses for Myopia Control: A 1-Year Randomized, Double-Masked, Controlled Trial. Ophthalmology. 2024 Dec;131(12):1389-1397. doi: 10.1016/j.ophtha.2024.07.002. Epub 2024 Jul 6.
PubMed 38972357
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 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 Trans-PRK
- ClinicalTrials.gov ID
- NCT06852105
- Acronym / sponsor ID
- PRK2025
- Conditions
- Dry Eye, Tear Break-Up Time
- Keywords
- dry eye, Trans-PRK
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- He Eye HospitalUniversity, hospital or other
- Study start
- 28 Feb 2025 (estimated)
- Primary completion
- 28 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 28 Feb 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 Trans-PRK
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 Trans-PRK surgery, and no study has shown that diquafosol sodium has a role in nerve recovery after Trans-PRK 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 Trans-PRK. The observation of changes in corneal nerves and immune-inflammatory cells was added, aiming to observe the repair effect of difossol sodium on corneal nerves.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Other | Drug: 3% Diquafosol Sodium Eye Dropsdry eye patients after Trans-PRK |
| Control group | Other | Drug: 0.1% hyaluronic aciddry eye patients after Trans-PRK |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-40 years.
- The refractive status should be maintained at least for more than 2 years, during which the annual increase in myopia should be controlled within 0.50 D.
- Pherical equivalent (SE) ≤-6.00D, astigmatic power≤-2.00D.
- Best corrected vision before surgery≥1.0.
- Patients should stop wearing soft contact lenses for at least 2 weeks and hard contact lenses for at least 4 weeks before surgery.
Key exclusion criteria (6 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.
- The thickness of the cornea does not meet the preset cutting depth requirement: the thickness of the central cornea should be greater than 450 μm, and the thickness of the central corneal stroma remaining under the corneal flap should be maintained above 250 μm after the intended cutting (280 μm recommended).
- Dry eye.
- There are serious lesions in the accessory structures of the eye, such as defects or deformations of the eyelids.
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: day 1, week 1, 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: day 1, week 1, week 4, week 12 and week 24
Tear film lipid layer (TFLL) score
Time frame: day 1, week 1, week 4, week 12 and week 24
Corneal Sensitivity Score
Time frame: day 1, week 1, week 4, week 12 and week 24
Tear meniscus height (TMH)
Time frame: day 1, week 1, week 4, week 12 and week 24
Conjunctival hyperemia (RS score):
Time frame: day 1, week 1, week 4, week 12 and week 24
Meibomian quality
Time frame: day 1, week 1, week 4, week 12 and week 24
Corneal nerves and immune/inflammatory cell change:
Time frame: 1 week, 12 weeks and 24 weeks after surgery.
OSDI
Time frame: day 1, week 1, week 4, week 12 and week 24
Meibomian gland expressibility
Time frame: day 1, week 1, 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 28 Feb 2025.
- Background: PubMed 39530399Zaabaar E, Asiamah R, Kyei S, Ankamah S. Myopia control strategies: A systematic review and meta-meta-analysis. Ophthalmic Physiol Opt. 2025 Jan;45(1):160-176. doi: 10.1111/opo.13417. Epub 2024 Nov 12.
- Background: PubMed 39528007Du Y, Di Y, Yang S, Li Y. Analysis of the changes in corneal optical density following small incision lenticule extraction for myopia and related influencing factors. Photodiagnosis Photodyn Ther. 2024 Dec;50:104397. doi: 10.1016/j.pdpdt.2024.104397. Epub 2024 Nov 9.
- Background: PubMed 38507901Mu J, Zhong H, Jiang M, Wang J, Zhang S. Development of a nomogram for predicting myopia risk among school-age children: a case-control study. Ann Med. 2024 Dec;56(1):2331056. doi: 10.1080/07853890.2024.2331056. Epub 2024 Mar 20.
- Background: PubMed 39120023Zhao L, Zhang Y, Duan H, Yang T, Ma B, Zhou Y, Chen J, Chen Y, Qi H. Clinical Characteristic and Tear Film Biomarkers After Myopic FS-LASIK: 1-Year Prospective Follow-up. J Refract Surg. 2024 Aug;40(8):e508-e519. doi: 10.3928/1081597X-20240514-05. Epub 2024 Sep 1.
- Background: PubMed 39576656Hou X, Chen P, Yu N, Luo Y, Wei H, Zhuang J, Yu K. A Comparative and Prospective Study of Corneal Consumption and Corneal Biomechanics After SMILE and FS-LASIK Performed on the Contralateral Eyes With High Myopic Astigmatism. Transl Vis Sci Technol. 2024 Nov 4;13(11):29. doi: 10.1167/tvst.13.11.29.
- Background: PubMed 38867491Yang F, Yang Z, Zhao S, Huang Y. To Investigate the Changes in Corneal Curvature and Its Correlation with Corneal Epithelial Remodeling After Trans-PRK and FS-LASIK. Curr Eye Res. 2024 Oct;49(10):1061-1067. doi: 10.1080/02713683.2024.2361728. Epub 2024 Jun 12.
- Background: PubMed 38972357Su B, Cho P, Vincent SJ, Zheng J, Chen J, Ye C, Wang T, Zhang J, Zhang K, Lu F, Jiang J. Novel Lenslet-ARray-Integrated Spectacle Lenses for Myopia Control: A 1-Year Randomized, Double-Masked, Controlled Trial. Ophthalmology. 2024 Dec;131(12):1389-1397. doi: 10.1016/j.ophtha.2024.07.002. Epub 2024 Jul 6.
- Individual participant dataSharing planned: Undecided
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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.
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 and Tear Break-Up Time, 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 6 inclusion and 6 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 28 Feb 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?
Contact Guanghao Qin Principal Investigator (+86-1884266442, qinguanghao2020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-invasive tear break-up time (NITBUT) (time frame: day 1, week 1, 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?
On the ClinicalTrials.gov record for NCT06852105, which also lists 7 linked publications.
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 28 Feb 2025.