Comparison of treatment with preservative-free versus preserved dexamethasone 0.1% and diclofenac 0.1% eye drops after cataract surgery.
Phase 1
- Conditions
- Treatment after cataract surgeryTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2017-004127-79-BE
- Lead Sponsor
- Z Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
•Patients diagnosed with age-related cataract
•Age 60 years or above
•No corneal punctate fluorescein staining at screening visit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
Exclusion Criteria
•Unwilling to sign informed consent
•Any use of eye drops during at least 3 months before surgery
•Pre-existing dry eye disease
•Previous ocular injury, surgery or laser treatment, infection, uveitis
•Wearing of contact lens
•Known or suspected allergy to any of the ingredients on the study medications
•Presence of uncontrolled systemic disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare treatment with preservative-free dexamethasone 0.1% (Monofree Dexamethason) and diclofenac 0.1% (Dicloabak) eye drops versus preserved dexamethasone 0.1% (Maxidex) and diclofenac 0.1% (Voltaren Ophtha CD) eye drops after cataract surgery in terms of postoperative inflammation, iatrogenic dry eye disease and macular edema.;Secondary Objective: Not applicable ;Primary end point(s): The primary endpoint will be the change from baseline (screening visit) of aqueous flare value at week 1 and 4 after cataract surgery;Timepoint(s) of evaluation of this end point: week 1 and 4
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Conjunctival hyperemia at week 1 and 4<br>•Corneal fluorescein staining at week 1 and 4<br>•Tear-film breakup time at week 1 and 4<br>•Corneal sensitivity at week 1 and 4<br>•Macular thickness at week 4<br>•OSDI score at week 1 and 4<br>•Conjunctival impression cytology at week 4<br>•Inflammatory cytokine activities in tears at week 4;Timepoint(s) of evaluation of this end point: week 1 and 4