Comparison of 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) eye drops after cataract surgery.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517572-38-00

Enrollment

100

Registered

2024-11-07

Start date

2018-10-03

Completion date

2025-11-18

Last updated

2024-11-07

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

Conditions

cataract

Brief summary

the primary endpoint will be the superiority of group without conservative (WC) on group with conservative (C) on aqueous flare value at week 4 after cataract surgery

Detailed description

tear osmolarity, conjunctival hyperemia, corneal fluorescein staining, tear-film breakup time, corneal sensitivity, central macular thickness, DEQ-5 score, inflammatory cytokine activities in tears, amount of tears, effect of conservatives on the ocular surface microbiome post cataract surgery

Interventions

DRUGMonofree Dexamethason 1 mg/ml

DRUGoogdruppels

DRUGoplossing in verpakking voor éénmalig gebruik

DRUGDicloabak 1 mg/ml collyre en solution

DRUGMAXIDEX 1 mg/ml oogdruppels

DRUGsuspensie

DRUGVoltaren ophtha 1 mg/ml Augentropfen

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
tear osmolarity, conjunctival hyperemia, corneal fluorescein staining, tear-film breakup time, corneal sensitivity, central macular thickness, DEQ-5 score, inflammatory cytokine activities in tears, amount of tears, effect of conservatives on the ocular surface microbiome post cataract surgery	—

Primary

Measure	Time frame
the primary endpoint will be the superiority of group without conservative (WC) on group with conservative (C) on aqueous flare value at week 4 after cataract surgery	—

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026