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The effect of 3% Diquafosol Sodium ophthalmic solution on the patient diagnosed as the dry eye after a cataract surgery (multicenter randomized clinical trial)

The effect of 3% Diquafosol Sodium ophthalmic solution on the patient diagnosed as the dry eye after a cataract surgery (multicenter randomized clinical trial) - The effect of 3% Diquafosol Sodium ophthalmic solution on the patient diagnosed as the dry eye after a cataract surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016060
Enrollment
200
Registered
2015-01-13
Start date
2015-01-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry eye

Interventions

Diquafosol Sodium ophthalmic solution 3% Artificial tear MYTEAR ophthalmic solution

Sponsors

Miyake Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: To have a plan to be given an age-related cataract surgery (confine to phacoemulsification and aspiration, any incision). Patients who are diagnosed as definite or probable dry eye by Dry Eye Diagnostic Criteria (study eye). Corneal and conjunctival staining is 1 or more than 1 point(study eye)

Exclusion criteria

Exclusion criteria: Patients who have allergic conjunctivitis and have possibilities to get worse during study phase. Patients who have glaucoma and uveitis requiring treatment. (study eye) Histories of Lasik, blepharoplasty, ocular injury or corneal transplants. (study eye) Patients who have diabetic retinopathy. (study eye) History of allogeneic heamatopoietic stem cell transplantation. Known allergy to any drug to be used during study phase. Patients who had a continued use of eye drops for dry eye within 2 weeks before this study. (study eye) Patients who had a punctal plug (study eye) Plans to use a prohibited concomitant drug during study phase. (study eye) Plans to receive prohibited concurrent therapy during study phase. (study eye) Those who need to wear contact lenses during study phase. (study eye) Cannot make the specified hospital visits. The investigator/subinvestigator has judged that the patient is ineligible as study subject.

Design outcomes

Primary

MeasureTime frame
The incidence rate of dry eye after cataract surgery. Tear film breakup time (BUT). Corneal and conjunctival staining score. Subjective symptoms (12 items). Adverse event and side effect.

Countries

Japan

Contacts

Public ContactKensaku Miyake

Miyake Eye Hospital No

m-abe111007@hotmail.co.jp052-915-8001

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026