Comparison of diquafosol sodium 3% versus hyaluronic acid 0.1% in the patients dry eye after cataract surgery

Phase 4

Recruiting

• Conditions: Dry eye disease after cataract surgery; D015352

• Registration Number: JPRN-jRCT1031210018
• Lead Sponsor: Inomata Takenori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

1) Women over 20 years old
2) Patients who have undergone cataract surgery in both eyes within 14 days of completing the first eye
3) 3.Patients diagnosed with DED after cataract surgery (More than 13 points of J-OSDI total score and tear film breakup time less than 5 seconds)
4) 4.Patients who, after receiving a full explanation of their participation in the study and with a full understanding of the study, have given written consent of their own free will to participate in the study
5) In case of inability to self-administer eye drops, patients with a caregiver willing to and able to assist in administration of the assigned eye drop as part of the study

Exclusion Criteria

1) Patients with dry eye diagnosed prior to cataract surgery (J-OSDI of 13 points or higher and tear layer breakup time of 5 seconds or less)
2) Patients with active eye infections
3) Spring catarrh patients
4) Patients with recurrent corneal erosions
5) Patients with hereditary corneal disease
6) Patients with physical irritation of the cornea and conjunctiva due to wear and tear or laxity of the ocular conjunctiva
7) Patients who cannot or will not be able to discontinue ophthalmic medications other than concomitantly restricted medications (including all prescription and OTC medications) from the initial screening examination to the end of the study medication eye drop
8) Patients who cannot stop using their contact lenses from the start of the screening examination until the end of the study drug eye drop
9) Patients after corneal refractive surgery
10) Patients with a teardrop plug or a history of surgical teardrop closure
11) Patients with hypersensitivity to the components of the study drug and the study's test product
12) Patients using glaucoma eye drops
13) Patients with systemic diseases, suchas diabetes mellitus, thyroid disease. Autoimmune diseases, and atopic dermatitis
14) Other patients who are deemed by the principal investigator to be unsuitable as research subjects

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absolute value of the J-OSDI total score (Dry eye disease specific questionnaire) at 4 weeks after treatment

Secondary Outcome Measures

Name	Time	Method
acrimal secretion (Schirmer test), at 4 weeks after treatment<br>Tear film breakup time, at 4 weeks after treatment<br>Kerato-conjunctival vital staining score, at 4 weeks after treatment<br>Maximum blink interval, at 4 weeks after treatment<br>Meibomian gland function, at 4 weeks after treatment<br>J-OSDI total score (baseline, 8 weeks after treatment, 12 weeks after treatment, 25 after treatmentt) based on the J-OSDI (dry eye disease-specific questionnaire)<br>Tear secretion volume (Schirmer's test) (baseline and at each evaluation point)<br>Tear film breakup time (baseline and at each evaluation point) <br>Kerato-conjunctival vital staining score (baseline, at each evaluation point)<br>Maximum blink interval (baseline, at each evaluation point)<br>Meibomian gland function (baseline and at each assessment point)<br>and the change at each assessment point from the baseline for each item<br>We will also evaluate whether the patient meets the dry eye diagnostic criteria for dry eye recurrence at 25 weeks.