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

NCT04050644 | Recruiting Phase 4

• 1 other identifier: S60915
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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) eye drops after cataract surgery in terms of postoperative inflammation, iatrogenic dry eye disease and cystoid macular edema.

Conditions

Age-related Cataract

Keywords

Preservative-free ocular drops; Preserved ocular drops

Outcome Measures

Primary Outcomes (1)

• The superiority of treatment arm without conservative (WC) on treatment arm with conservative (C) on the aqueous flare value in the operated eye, measured with a laser flare meter, at week 4 after cataract surgery.

  The Laser Flaremeter can measure the protein density in the anterior chamber by counting the photons. Flare Value is expressed in photoncount/ms. 1-9 photoncounts/ms is a normal value. Photoncount/ms from 10-500 is abnormal and indicates an inflamed eye.

  4 weeks

Secondary Outcomes (9)

• Tear Osmolarity

  4 weeks

• Conjunctival Hyperemia

  4 weeks

• Corneal Fluorescein Staining

  4 weeks

• Tear-film break up time

  4 weeks

• Corneal Sensitivity

  4 weeks

Study Arms (2)

Preservative-free dexamethasone 0.1%/diclofenac 0.1%

EXPERIMENTAL

One week before surgery, patients will be randomized to either receive the preservative-free dexamethasone 0.1% and diclofenac 0.1% eye drops.

Drug: Preservative Free drop treatment

Preserved dexamethasone 0.1%/diclofenac 0.1%

ACTIVE COMPARATOR

One week before surgery, patients will be randomized to either receive the preserved dexamethasone 0.1% and diclofenac 0.1% eye drops.

Drug: Preserved drop treatment

Interventions

Preservative Free drop treatment DRUG

Patients will use the preservative-free dexamethasone 0.1% 4 times a day in the first week after cataract surgery, 3 times a day in the second week, twice daily in the third week and once daily in the fourth week and diclofenac 0.1% eye drops 3 times daily for 1 day preoperatively and every 15 minutes in the hour before surgery and then 3 times a day for four weeks.

Preservative-free dexamethasone 0.1%/diclofenac 0.1%

Preserved drop treatment DRUG

Patients will use the preserved dexamethasone 0.1% 4 times a day in the first week after cataract surgery, 3 times a day in the second week, twice daily in the third week and once daily in the fourth week and diclofenac 0.1% eye drops 3 times daily for 1 day preoperatively and every 15 minutes in the hour before surgery and then 3 times a day for four weeks.

Preserved dexamethasone 0.1%/diclofenac 0.1%

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with age-related cataract
• Age 60 years or above

You may not qualify if:

• Unwilling to sign informed consent
• Pseudoexfoliation syndrome
• Functionally monocular patient
• Any use of eye drops during at least 3 months before surgery with the exception of artificial tears
• Pre-existing dry eye disease according to the criteria's of the TFOS DEXS II report
• Previous ocular surgery, laser treatment or uveitis, with the exception of retinal laser treatment (more than 6 months ago) and iridotomy (more than 6 months ago)
• Active conjunctivitis
• Wearing of contact lens
• Presence of any macular diseases possibly impacting visual acuity
• Presence of any ocular diseases leading to difficulty to have a correct eye examination
• Known or suspected allergy to any of the ingredients on the study medications
• Presence of uncontrolled systemic disease

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Laboratoires Thea: collaborator

Study Sites (2)

Universitaire Ziekenhuizen Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

AZ Delta

Roeselare, West-Vlaanderen, 8800, Belgium

RECRUITING

Study Officials

• Heleen Delbeke, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heleen Delbeke, MD

CONTACT

+32 16 332687; heleen.delbeke@uzleuven.be

Ingeborg Stalmans, MD, PhD

CONTACT

+32 16 332687; ingeborg.stalmans@uzleuven.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Prospective, randomized controlled trial, investigator masked. * Patients requiring cataract surgery and who consent to participate will be enrolled in this study. * The patient can opt to participate in an sub-investigation researching a correlation between the microbiome and ocular surface inflammation post cataract surgery.

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 8, 2019
• Study Start: October 30, 2018
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

BE (2)