N/A
N=86
Clinical Effects and Safety of 3% Diquafosol After Cataract Surgery
Dry Eye Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT02608489 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: an Ocular Surface Disease Index (OSDI) Questionnaire That is Related to Dry Eye Severity. — 21.09; 23.00; 31.28; 20.31 scores on a scale — p=0.221
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Diquafosol (Diquas) (Drug); Sodium Hyaluronate (Hyalein) (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Soonchunhyang University Hospital
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY an Ocular Surface Disease Index (OSDI) Questionnaire That is Related to Dry Eye Severity. |
21.09; 23.00; 31.28; 20.31; 20.31; 23.00 | 0.221 |
| PRIMARY Schirmer I Test Without Anesthesia That is Related to Dry Eye Severity. |
3.61; 3.69; 2.03; 1.76; 3.22; 2.59 | 0.256 |
| PRIMARY Changes in HOAs After Blinking That is Related to Dry Eye Severity. |
0.042; 0.041; 0.153; 0.260; 0.067; 0.074 | 0.080 |
| PRIMARY Tear Break-up Time (TBUT) That is Related to Dry Eye Severity. |
4.98; 4.50; 3.50; 3.00; 5.64; 3.96 | <0.001 sig |
| PRIMARY Corneal Fluorescein Staining That is Related to Dry Eye Severity. |
1.52; 1.78; 2.09; 2.88; 1.09; 1.73 | 0.045 sig |
| PRIMARY Lissamine Green (LG) Conjunctival Staining That is Related to Dry Eye Severity |
1.40; 1.91; 2.56; 3.86; 0.86; 2.31 | 0.001 sig |
| SECONDARY Grades of Anterior Chamber Cells. |
0; 0; 1.54; 1.78; 0.16; 0.36 | 0.151 |
| SECONDARY Number of Participants Who Stop Using the Eye Drops Due to Drug-related Discomfort |
1; 0 | — |
Summary
The purpose of this study is determine whether 3% diquafosol and 0.1% sodium hyaluronate are effective and safe in the treatment of patients with dry eye after cataract surgery.
Eligibility Criteria
Inclusion Criteria
- Bilateral or unilateral cataract undergoing phacoemulsification and intraocular lens (IOL) implantation at Soonchunhyang University Hospital between January 2014 and January 2015
- Patients with mild to moderate dry eye (level 1 or 2) based on the dry eye severity scale adopted by the Dry Eye Workshop (DEWS) report and who used only artificial tears occasionally
Exclusion Criteria
- Presence of any complications after cataract surgery such as cystoid macular edema
- Patients using any topical eye drops on a regular basis
- Treatment history of dry eye beyond artificial tears
- Any ocular surgery within the prior 6 months
- Contact lens wear
- Serious ocular surface disease (e.g., Sjögren's syndrome, ocular pemphigoid, conjunctival scarring, chemical injury)
- Eyelid or lacrimal disease
- Use of concomitant medications that could cause dry eye and allergy to any of the study medications
Data sourced from ClinicalTrials.gov (NCT02608489). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.