Comparison of treatment with preservative-free versus preserved dexamethasone 0.1% and diclofenac 0.1% eye drops after cataract surgery.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004127-79-BE

Enrollment

100

Registered

2018-01-26

Start date

2018-05-09

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Treatment after cataract surgery

Interventions

Trade Name: Monofree Dexamethason 0.1% Pharmaceutical Form: Eye drops, solution in single-dose container INN or Proposed INN: Corticosteroid CAS Number: 312-93-6 Other descriptive name: DEXAMETHASONE

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
Secondary end point(s): • Conjunctival hyperemia at week 1 and 4 • Corneal fluorescein staining at week 1 and 4 • Tear-film breakup time at week 1 and 4 • Corneal sensitivity at week 1 and 4 • Macular thickness at week 4 • OSDI score at week 1 and 4 • Conjunctival impression cytology at week 4 • Inflammatory cytokine activities in tears at week 4;Timepoint(s) of evaluation of this end point: week 1 and 4	—

Measure

Time frame

Secondary end point(s): • Conjunctival hyperemia at week 1 and 4 • Corneal fluorescein staining at week 1 and 4 • Tear-film breakup time at week 1 and 4 • Corneal sensitivity at week 1 and 4 • Macular thickness at week 4 • OSDI score at week 1 and 4 • Conjunctival impression cytology at week 4 • Inflammatory cytokine activities in tears at week 4;Timepoint(s) of evaluation of this end point: week 1 and 4

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Countries

Belgium

Contacts

Public ContactSien Boons

UZ Leuven

sien.boons@uzleuven.be0032016340391

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026