An observational study in Dry Eye Disease, sponsored by Le Xuan Cung. Completed at 1 site in Vietnam. Per ClinicalTrials.gov, last updated 2025-08-14.
Sponsored by Le Xuan Cung · Observational
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 60 is below the median of 90 across 171 observational studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →This is the only study on the registry with Le Xuan Cung as lead sponsor.
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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
Exclusion Criteria:
Drug: 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
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)
Time frame: 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.
Time frame: From starting diquafosol (baseline) to 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From starting diquafosol (baseline) to 12 weeks
Rate of side effects of diquafosol
Rate of side effects of diquafosol will be assessed at each examination.
Time frame: From starting diquafosol (baseline) to 12 weeks
Influence of Risk Factors on Treatment Effectiveness
The influence of risk factors on treatment effectiveness will be evaluated (yes or no, influence or not). A Fisher's Exact Test will determine if there is a statistically significant difference (p\<0.05) between subgroups of a specific risk factor.
Time frame: From starting diquafosol (baseline) to 12 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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