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.

2024-517572-38-00 Therapeutic use (Phase IV) Ended

Start 3 Oct 2018 · End 18 Nov 2025 · Status Ended · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ended
Participants planned 100
Countries 1
Sites 1

cataract

Comparison of treatment with preservative-free eye drops versus preserved eye drops after cataract surgery

Key facts

Sponsor
UZ Leuven
Participant type
Patients
Age range
65+ years
Gender
Male and Female
Therapeutic area
Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
Trial duration
3 Oct 2018 → 18 Nov 2025
Decision date (initial)
2024-11-07
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2024-517572-38-00
EudraCT number
2017-004127-79

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Comparison of treatment with preservative-free eye drops versus preserved eye drops after cataract surgery

Conditions and MedDRA coding

cataract

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

  1. patients diagnosted with age-related cataract
  2. Age 60 years or above

Exclusion criteria 6

  1. Pre-existing dry eye disease according to the criteria's of the TFOS DEXS II report
  2. pseudoexfoliation syndrome
  3. functionally monocular patient
  4. any use of eye drops during at least 3 months before surgery with exception of artificial tears
  5. previous ocular injury, surgery or laser treatment, uveitis
  6. presence of any macular disease possibly impacting visual acuity

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. 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

Secondary endpoints 10

  1. tear osmolarity
  2. conjunctival hyperemia
  3. corneal fluorescein staining
  4. tear-film breakup time
  5. corneal sensitivity
  6. central macular thickness
  7. DEQ-5 score
  8. inflammatory cytokine activities in tears
  9. amount of tears
  10. effect of conservatives on the ocular surface microbiome post cataract surgery

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Monofree Dexamethason 1 mg/ml, oogdruppels, oplossing in verpakking voor éénmalig gebruik

PRD403526 · Product

Active substance
Dexamethasone Phosphate
Substance synonyms
DEXAMETHASONE 21-(DIHYDROGEN PHOSPHATE)
Pharmaceutical form
EYE DROPS, SOLUTION
Route of administration
OCULAR USE
Max daily dose
6 1X 100 milligrams/millilitre
Max total dose
6 1X 100 milligrams/millilitre
Max treatment duration
4 Week(s)
Authorisation status
Authorised
ATC code
S01BA01 — DEXAMETHASONE
Marketing authorisation
RVG 18658
MA holder
LABORATOIRES THEA
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dicloabak 1 mg/ml collyre en solution

PRD413356 · Product

Active substance
Diclofenac Sodium
Substance synonyms
DICLOFENACUM NATRICUM, DICLOPHENAC SODIUM, SODIUM 2-[2-[(2,6-DICHLOROPHENYL)AMINO]PHENYL]ACETATE
Pharmaceutical form
EYE DROPS, SOLUTION
Route of administration
OCULAR USE
Max daily dose
3 1X 100 milligrams/millilitre
Max total dose
3 1X 100 milligrams/millilitre
Max treatment duration
4 Week(s)
Authorisation status
Authorised
ATC code
S01BC03 — DICLOFENAC
Marketing authorisation
BE291225
MA holder
LABORATOIRES THEA
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 2

MAXIDEX 1 mg/ml oogdruppels, suspensie

PRD4973381 · Product

Active substance
Dexamethasone
Substance synonyms
DEXAMETASONE, DEXAMETHASONUM
Pharmaceutical form
EYE DROPS, SUSPENSION
Route of administration
OCULAR USE
Max daily dose
6 1X 100 milligrams/millilitre
Max total dose
6 1X 100 milligrams/millilitre
Max treatment duration
4 Week(s)
Authorisation status
Authorised
ATC code
S01BA01 — DEXAMETHASONE
Marketing authorisation
BE038857
MA holder
NOVARTIS PHARMA N.V.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Voltaren ophtha 1 mg/ml Augentropfen

PRD11689949 · Product

Active substance
Diclofenac Sodium
Substance synonyms
DICLOFENACUM NATRICUM, DICLOPHENAC SODIUM, SODIUM 2-[2-[(2,6-DICHLOROPHENYL)AMINO]PHENYL]ACETATE
Pharmaceutical form
EYE DROPS, SOLUTION
Route of administration
OCULAR USE
Max daily dose
3 1X 100 milligrams/millilitre
Max total dose
34 1X 100 milligrams/millilitre
Max treatment duration
4 Week(s)
Authorisation status
Authorised
ATC code
S01BC03 — DICLOFENAC
Marketing authorisation
11202.00.00
MA holder
LABORATOIRES THEA
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

70 Total trials 41 Recruiting 22 Ended
Academic / Non-commercial
Sponsor organisation
UZ Leuven
Address
Herestraat 49
City
Leuven
Postcode
3000
Country
Belgium

Scientific contact point

Organisation
UZ Leuven
Contact name
Clinical Trial Center

Public contact point

Organisation
UZ Leuven
Contact name
Clinical Trial Center

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ended 100 1
Rest of world — 0 —

Investigational sites

Belgium

1 site · Ended
UZ Leuven
Oftalmology, Herestraat 49, 3000, Leuven

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Belgium 2018-10-03 2025-11-18 2018-10-03

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) PROTOCOL 2024-517572-38 12
Recruitment arrangements (for publication) patientrecruitmentprocedure_en_S60915 1
Subject information and informed consent form (for publication) S60915_ICF_ 2024-517572-38 11
Summary of Product Characteristics (SmPC) (for publication) smpc dicloabak-2 1
Synopsis of the protocol (for publication) Synopsis_NL 2024-517572-38 6

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-29 Belgium Acceptable
2024-11-05
 2024-11-07

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