The effect of 3% Diquafosol Sodium ophthalmic solution on the patient diagnosed as the dry eye after a cataract surgery (multicenter randomized clinical trial)
- Conditions
- Dry eye
- Registration Number
- JPRN-UMIN000016060
- Lead Sponsor
- Miyake Eye Hospital
- Brief Summary
Subjects were 433 eyes of 433 patients undergoing cataract surgery with intraocular lens implantation. Dry eye examination of tear breakup time (BUT), corneal and conjunctival fluorescein staining scores, total subjective symptom score (12 symptoms), and Schirmer I test were conducted before surgery and 4 weeks after surgery At 4 weeks after surgery, tear breakup time (BUT) was shortened significantly (P=0.036) than before surgery, corneal and conjunctival fluorescein staining score increased significantly (P=0.012). But total subjective symptom score (12 symptoms) was significantly improved (P < 0.001). The majority of postoperative dry eye was shortened BUT type (53.1%). The dry eye prevalence after surgery decreased (55.7%) compared with before surgery (69.7%). Females and the patient with dry eye symptoms before surgery had significant risk factors for postoperative dry eye. In a randomized study for postoperative dry eye, 154 eyes of 154 patients diagnosed with dry eye postoperatively were applied either 3% Diquafosol Sodium ophthalmic solution (DQS) or artificial tears (AT) six times daily for 4 weeks. BUT after 4 weeks instillation was significantly prolonged in the DQS group (P=0.015), but not in the AT group. Fluorescein staining score was significantly improved in both groups (P<0.001). Total subjective symptom score was significantly decreased in the AT group (P<0.001), but not in the DQS group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method