Dry Eye DiseaseNCT07122635
Effectiveness of Dry Eye Treatment With Diquafosol Sodium 3% After Phaco Surgery
An observational study of Dry Eye Disease, run by Le Xuan Cung at 1 site in Vietnam.
Trial summary
The goal of this observational study is to evaluate the effectiveness of diquafosol sodium 3% in patients undergoing phacoemulsification surgery and having dry eye 1 week after the surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Diquafosol Sodium 3%
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 3 Oct 2024to 31 Mar 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with grade 1, grade 2 or grade 3 dry eye according to DEWS 2007 classification and Sullivan's severity grading scheme one week after phacoemulsification surgery with IOL implantation
Who may be able to join
- Patients undergoing phacoemulsification surgery with IOL implantation
- Diagnosis with grade 1, grade 2 or grade 3 dry eye one week after the surgery according to DEWS 2007 classification and Sullivan's severity grading scheme
Who cannot join
- Patients with grade 3 or 4 dry eye before phaco surgery
- Phaco surgery with complications during or after surgery
- Patients with other eye surgeries within 6 months before phaco surgery
- Patients who are using other eye drops before phaco surgery, except artificial tears
- Patients with acute eye infections
- Patients who do not return for follow-up appointments
Show all 9Show fewer
- Patients who do not comply with treatment
- Patients having allergy with diquafosol 3%
- Patients having side effects with diquafosol 3% and do not want to continue using the drug
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to evaluate the effectiveness of diquafosol sodium 3% in patients undergoing phacoemulsification surgery and having dry eye 1 week after the surgery. The main question it aims to answer is whether using diquafosol will help improve symptoms and signs of dry eye in patients after phaco surgery.
- Conditions
- Dry Eye Disease
- Being tested
- Diquafosol Sodium 3%
- Keywords
- Diquafosol, dry eye, phaco surgery, cataract surgery
- 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.
Diquafosol Sodium 3%Drug
Diquafosol Sodium 3% ophthalmic solution, 1 drop each time, 6 times daily, from baseline (1 week after the surgery) to 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing phacoemulsification surgery and having dry eye 1 week after the surgery | Not described Receives: Drug: Diquafosol Sodium 3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in OSDI score
Change in OSDI score after treatment with diquafosol from baseline (1 week after surgery) to 4 weeks, 8 weeks, 12 weeks.
At the preoperative and postoperative examinations, patient will be evaluated dry eye symptoms according to the OSDI questionnaire (from 0-100 points)
Measured: From starting diquafosol (baseline) to 12 weeks
Change in Tear film breakup time (TBUT) score
Change in tear film breakup time (TBUT) score after treatment with diquafosol from baseline (1 week after surgery) for 4 weeks, 8 weeks, 12 weeks.
At the preoperative and postoperative examinations, patient will be evaluated tear film breakup time which is measured after fluorescein staining. At each examination, TBUT score is measured 3 times to calculate the average value.
Measured: From starting diquafosol (baseline) to 12 weeks
Secondary outcomes (5)
Change in Schirmer I test value
Change in Schirmer I test value after treatment with diquafosol from baseline (1 week after surgery) for 4 weeks, 8 weeks, 12 weeks.
At the preoperative and postoperative examinations, patient will be evaluated total tear secretion using the Schirmer I test.
Measured: From starting diquafosol (baseline) to 12 weeks
Change in Tear meniscus height
Change in Tear meniscus height after treatment with diquafosol from baseline (1 week after surgery) for 4 weeks, 8 weeks, 12 weeks.
At the preoperative and postoperative examinations, tear meniscus height will be measured using TMH mode on Keratograph 5M machine.
Measured: From starting diquafosol (baseline) to 12 weeks
Change in Corneal staining score
Change in corneal staining score after treatment with diquafosol from baseline (1 week after surgery) for 4 weeks, 8 weeks, 12 weeks.
At the preoperative and postoperative examinations, patient will be evaluated corneal staining score, which is measured after fluorescein staining and calculated according to NEI grading scale.
Measured: From starting diquafosol (baseline) to 12 weeks
Change in Conjunctival staining score
Change in conjunctival staining score after treatment with diquafosol from baseline (1 week after surgery) for 4 weeks, 8 weeks, 12 weeks.
At the preoperative and postoperative examinations, patient will be evaluated conjunctival staining score, which is measured after Lissamine green staining and calculated according to NEI grading scale.
Measured: From starting diquafosol (baseline) to 12 weeks
Change in Tear film breakup pattern
Change in tear film breakup pattern from baseline (1 week after surgery) and after 12 weeks of treatment with diquafosol.
Tear film breakup pattern will be assessed after fluorescein staining.
Measured: From starting diquafosol (baseline) to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start3 Oct 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Le Xuan Cung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Le Xuan Cung, Vietnam National Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122635
- Sponsor's protocol ID
- 764/QD-BVMTW No. 17
- Status last verified
- Aug 2025
- First submitted
- 7 Jul 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dry Eye Treatment With Diquafosol Sodium 3% After Phaco Surgery
- ClinicalTrials.gov ID
- NCT07122635
- Acronym / sponsor ID
- 764/QD-BVMTW No. 17
- Conditions
- Dry Eye Disease
- Keywords
- Diquafosol, dry eye, phaco surgery, cataract surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Le Xuan CungUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 14 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 goal of this observational study is to evaluate the effectiveness of diquafosol sodium 3% in patients undergoing phacoemulsification surgery and having dry eye 1 week after the surgery. The main question it aims to answer is whether using diquafosol will help improve symptoms and signs of dry eye in patients after phaco surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing phacoemulsification surgery and having dry eye 1 week after the surgery | – | Drug: Diquafosol Sodium 3% |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with grade 1, grade 2 or grade 3 dry eye according to DEWS 2007 classification and Sullivan's severity grading scheme one week after phacoemulsification surgery with IOL implantation
Key inclusion criteria (2 listed)
- Patients undergoing phacoemulsification surgery with IOL implantation
- Diagnosis with grade 1, grade 2 or grade 3 dry eye one week after the surgery according to DEWS 2007 classification and Sullivan's severity grading scheme
Key exclusion criteria (9 listed)
- Patients with grade 3 or 4 dry eye before phaco surgery
- Phaco surgery with complications during or after surgery
- Patients with other eye surgeries within 6 months before phaco surgery
- Patients who are using other eye drops before phaco surgery, except artificial tears
- Patients with acute eye infections
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 |
|---|---|---|
| Diquafosol Sodium 3%Diquafosol Sodium 3% ophthalmic solution, 1 drop each time, 6 times daily, from baseline (1 week after the surgery) to 12 weeks | Drug | Patients undergoing phacoemulsification surgery and having dry eye 1 week after the surgery |
Primary outcome
Change in OSDI score
Time frame: From starting diquafosol (baseline) to 12 weeks
Change in OSDI score after treatment with diquafosol from baseline (1 week after surgery) to 4 weeks, 8 weeks, 12 weeks. At the preoperative and postoperative examinations, patient will be evaluated dry eye symptoms according to the OSDI questionnaire (from 0-100 points)
Change in Tear film breakup time (TBUT) score
Time frame: From starting diquafosol (baseline) to 12 weeks
Change in tear film breakup time (TBUT) score after treatment with diquafosol from baseline (1 week after surgery) for 4 weeks, 8 weeks, 12 weeks. At the preoperative and postoperative examinations, patient will be evaluated tear film breakup time which is measured after fluorescein staining. At each examination, TBUT score is measured 3 times to calculate the average value.
5 secondary outcomes
Change in Schirmer I test value
Time frame: From starting diquafosol (baseline) to 12 weeks
Change in Tear meniscus height
Time frame: From starting diquafosol (baseline) to 12 weeks
Change in Corneal staining score
Time frame: From starting diquafosol (baseline) to 12 weeks
Change in Conjunctival staining score
Time frame: From starting diquafosol (baseline) to 12 weeks
Change in Tear film breakup pattern
Time frame: From starting diquafosol (baseline) to 12 weeks
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 14 Aug 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Disease, run by Le Xuan Cung at 1 site in Vietnam.
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 2 inclusion and 9 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 14 Aug 2025. 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 Vietnam. 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 OSDI score (time frame: From starting diquafosol (baseline) to 12 weeks). 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 14 Aug 2025.