Age-related CataractPhase 4GISTNCT04050644
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
A Phase 4 study testing Preservative Free drop treatment and Preserved drop treatment in people with Age-related Cataract, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Age-related Cataract
- What is being tested?
- Preservative Free drop treatment and Preserved drop treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesBelgium
- Study dates
- 30 Oct 2018to Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with age-related cataract
- Age 60 years or above
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
Universitaire Ziekenhuizen Leuven
Leuven, Vlaams-Brabant, 3000
Ingeborg Vriens, +32 16 342229, ingeborg.vriens@uzleuven.be
- Recruiting
AZ Delta
Roeselare, West-Vlaanderen, 8800
Hilde Seynaeve, MD
About this study
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.
Read the detailed description
Cataract surgery is a standardized procedure yielding excellent visual outcomes in most patients. According to Daien et al., the incidence of cataract surgery in 2012 in France was 11/1000 person-years. Although there are few complications related to the surgery, patients often experience ocular discomfort in the postoperative period.
Postoperative treatment usually includes topical non-steroidal anti-inflammatory drugs and topical steroids for four weeks to control anterior chamber inflammation, to relieve ocular pain after surgery and to reduce the incidence of cystoid macular edema.
Benzalkonium chloride (BAK) is the most common eye drop preservative and is associated with several ocular adverse effects, including dry eye and ocular surface inflammation. Moreover, in two clinical trials comparing the effects of BAK-containing and preservative-free eye drops, anterior chamber inflammation was reported in response to BAK after 1 month of exposure. Finally, besides the fact that intra-ocular inflammation increases the risk of macular edema, there is some evidence in the literature suggesting that BAK may also contribute to the development of macular edema.
Because of these well-established detrimental effects of preservatives, pharmaceutical industry has invested in the development of preservative-free eye drops in the past decade, which has led to preservative-free alternatives for almost all the eye medications.
The aim of this project is to investigate whether omitting preservatives from the postoperative topical treatment after cataract surgery can reduce symptoms and signs of ocular surface disease, intra-ocular inflammation and the incidence of cystoid macular edema.
Additionally ocular microbiome research is added to our study because of its known correlation with the ocular immunity. Although the ocular surface is continuously colonized by a commensal microbial community, the healthy ocular surface is not in an inflammatory state. This phenomenon suggests that there is an interplay between the ocular surface microbiome and innate immune mechanisms, which prevents inflammatory responses against commensal microbiota.
St Leger et al. used a murine model to reveal the presence of a commensal, Corynebacterium mastitidis, on the ocular surface. Corynebacterium mastitidis elicited an IL-17 response from ƔΔT-cells, facilitating recruitment of neutrophils to the ocular surface and secretion of antimicrobial peptides in the tears. These findings suggest the presence of a functional resident microbiome on the ocular surface which contribute to immune homeostasis and protects the ocular surface from pathogens.
Our expert in the area of ocular microbiome research is affiliated with the department of biochemistry and microbiology of the University of Ghent.
- Conditions
- Age-related Cataract
- Being tested
- Preservative Free drop treatment, Preserved drop treatment
- Keywords
- Preservative-free ocular drops, Preserved ocular drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preservative Free drop treatmentDrug
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.
Preserved drop treatmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Preserved drop treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (9)
Tear Osmolarity
The difference in Tear Osmolarity between the two treatment arms. Tear Osmolarity value will be measured with TearLab.
Measured: 4 weeks
Conjunctival Hyperemia
The difference in Conjunctival Hyperemia between the two treatment arms. The scale that will be used is the Cornea and Contact Lens Research Unit (CCLRU) scale. Minimum score is 1, maximum score is 4.
Measured: 4 weeks
Corneal Fluorescein Staining
The difference in Corneal Fluorescein Staining between the two treatment arms. The grading scale that will be used is the Oxford grading scale. Minimum score is grade 0, maximum score is grade 5.
Measured: 4 weeks
Tear-film break up time
The difference in Tear-film break up time between the two treatment arms. The Tear-film break up time will be expressed in seconds.
Measured: 4 weeks
Corneal Sensitivity
The difference in Corneal Sensitivity between the two treatment arms. Corneal Sensitivity value will be measured with the Cochet-Bonnet Aesthesiometer, expressed in mm.
Measured: 4 weeks
Central macular thickness
The difference in Central Macular Thickness between the two treatment arms. Central Macular Thickness will be measured with OCT Cirrus, expressed in µm.
Measured: 4 weeks
DEQ-5 score
The difference in Five-item Dry Eye Questionnaire (DEQ-5) score between the two treatment arms. Minimum total score is 0, maximum total score is 22.
Measured: 4 weeks
Inflammatory cytokine activities in tears
The difference in Inflammatory cytokine activities in tears between the two treatment arms. The cytokines that will be measured are IL-1Bèta, TNF-Alpha, IL-6, IL-8, IL-17, INF γ, macrophage migration inhibitory factor,...
Measured: 4 weeks
Amount of tears
The difference in Amount of Tears between the two treatment arms. The Amount of Tears will be measured with Schirmer tear test strips. The strips will be placed in the lower eyelid pouch for 5 minutes, value is expressed in mm.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start30 Oct 2018
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related CataractStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoires Thea
- Responsible party
- Sponsor
- Investigators
- Heleen Delbeke, MD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050644
- Sponsor's protocol ID
- S60915
- Acronym
- GIST
- Status last verified
- Jun 2024
- First submitted
- 2 Aug 2019
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04050644
- Acronym / sponsor ID
- GIST / S60915
- Conditions
- Age-related Cataract
- Keywords
- Preservative-free ocular drops, Preserved ocular drops
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Laboratoires Thea
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cataract surgery is a standardized procedure yielding excellent visual outcomes in most patients. According to Daien et al., the incidence of cataract surgery in 2012 in France was 11/1000 person-years. Although there are few complications related to the surgery, patients often experience ocular discomfort in the postoperative period.
Postoperative treatment usually includes topical non-steroidal anti-inflammatory drugs and topical steroids for four weeks to control anterior chamber inflammation, to relieve ocular pain after surgery and to reduce the incidence of cystoid macular edema.
Benzalkonium chloride (BAK) is the most common eye drop preservative and is associated with several ocular adverse effects, including dry eye and ocular surface inflammation. Moreover, in two clinical trials comparing the effects of BAK-containing and preservative-free eye drops, anterior chamber inflammation was reported in response to BAK after 1 month of exposure. Finally, besides the fact that intra-ocular inflammation increases the risk of macular edema, there is some evidence in the literature suggesting that BAK may also contribute to the development of macular edema.
Because of these well-established detrimental effects of preservatives, pharmaceutical industry has invested in the development of preservative-free eye drops in the past decade, which has led to preservative-free alternatives for almost all the eye medications.
The aim of this project is to investigate whether omitting preservatives from the postoperative topical treatment after cataract surgery can reduce symptoms and signs of ocular surface disease, intra-ocular inflammation and the incidence of cystoid macular edema.
Additionally ocular microbiome research is added to our study because of its known correlation with the ocular immunity. Although the ocular surface is continuously colonized by a commensal microbial community, the healthy ocular surface is not in an inflammatory state. This phenomenon suggests that there is an interplay between the ocular surface microbiome and innate immune mechanisms, which prevents inflammatory responses against commensal microbiota.
St Leger et al. used a murine model to reveal the presence of a commensal, Corynebacterium mastitidis, on the ocular surface. Corynebacterium mastitidis elicited an IL-17 response from ƔΔT-cells, facilitating recruitment of neutrophils to the ocular surface and secretion of antimicrobial peptides in the tears. These findings suggest the presence of a functional resident microbiome on the ocular surface which contribute to immune homeostasis and protects the ocular surface from pathogens.
Our expert in the area of ocular microbiome research is affiliated with the department of biochemistry and microbiology of the University of Ghent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- * 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.
| Arm | Type | Receives |
|---|---|---|
| Preservative-free dexamethasone 0.1%/diclofenac 0.1% | Experimental | Drug: Preservative Free drop treatmentOne week before surgery, patients will be randomized to either receive the preservative-free dexamethasone 0.1% and diclofenac 0.1% eye drops. |
| Preserved dexamethasone 0.1%/diclofenac 0.1% | Active comparator | Drug: Preserved drop treatmentOne week before surgery, patients will be randomized to either receive the preserved dexamethasone 0.1% and diclofenac 0.1% eye drops. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with age-related cataract
- Age 60 years or above
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preservative Free drop treatmentPatients 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. | Drug | Preservative-free dexamethasone 0.1%/diclofenac 0.1% |
| Preserved drop treatmentPatients 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. | Drug | Preserved dexamethasone 0.1%/diclofenac 0.1% |
Primary outcome
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.
Time frame: 4 weeks
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.
9 secondary outcomes
Tear Osmolarity
Time frame: 4 weeks
Conjunctival Hyperemia
Time frame: 4 weeks
Corneal Fluorescein Staining
Time frame: 4 weeks
Tear-film break up time
Time frame: 4 weeks
Corneal Sensitivity
Time frame: 4 weeks
Central macular thickness
Time frame: 4 weeks
DEQ-5 score
Time frame: 4 weeks
Inflammatory cytokine activities in tears
Time frame: 4 weeks
Amount of tears
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heleen Delbeke, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Preservative Free drop treatment and Preserved drop treatment in people with Age-related Cataract, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heleen Delbeke, MD (+32 16 332687, heleen.delbeke@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.