Dry Eye SyndromesPhase 4NCT05433428
Metabolomic Profile in Dry Eye Syndrome Patients.
A Phase 4 study testing Lubricant Eye Drops, Preservative Free and Preservative in people with Dry Eye Syndromes and Cataract, run by Ifocus Oyeklinikk at 1 site in Norway.
Trial summary
The primary objective is to determine possible implications of deviant tear film quality for optimal refractive precision in patients scheduled for cataract surgery. The study consist of three separate arms where cataract patients will be separated in to Dry Eye Disease (DED) positive and negative groups. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes, Cataract
- What is being tested?
- Lubricant Eye Drops, Preservative Free and Preservative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteNorway
- Study dates
- 3 Aug 2020to 23 May 2023
- 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 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Indication for cataract surgery
- Signed informed consent
- no rheumatological or other systemic disease that involve the corneal surface
- a good ocular health with no pathology that compromises visual acuity (except cataract).
Who cannot join
- Manifest corneal disease or scarring
- Lid deformities
- Corneal ectasia
- Rheumatoid diseases or other systemic diseases that involve the corneal surface,
- Recent ocular surgery
- Previous refractive procedures
Show all 9Show fewer
- Diabetic retinopathy
- Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness)
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Ifocus øyeklinikk
Haugesund, 5521
Morten Gundersen, Dr, 48157846, morten@ifocus.no
Kjell Gunnar Gundersen, Dr.med, 91648707, kg@ifocus.no
About this study
Official title: Metabolomic Profile in Tear Film Samples of Patients With or Without Dry Eye Syndrome Before and After Cataract Surgery.
The primary objective is to determine possible implications of deviant tear film quality for optimal refractive precision in patients scheduled for cataract surgery.
The study consist of three separate arms where cataract patients will be separated in to Dry Eye Disease (DED) positive and negative groups. The DED positive group will be further subdivided into two different treatment groups (with focus on prolonged use of lubricant and preservative free eye drops). Tear film samples will be taken before treatment, after treatment and after surgical treatment and compared.
Read the detailed description
The participants will be randomized to either standard pre- and postoperative treatment protocol - hereby called the standard protocol - or a pre- and postoperative protocol where intensive dry eye treatment is implemented - hereby called the intensive dry eye treatment protocol. The intensive dry eye treatment protocol differs from the standard protocol in the use of preservative free eye drops and the use of topical steroids prior to surgery.
The standard treatment protocol is:
Before surgery:
- Nevanac 3 mg /mL
- Spersadex 1mg/ml three days before surgery.
After surgery:
Nevanac 3 mg /mL five days after surgery. Spersadex 1 mg/ml 20 days after surgery
The intensive dry eye treatment protocol is:
Before surgery:
Lubricants (Thealoz Duo) for four weeks. Preservative free dexamethasone 0.1% (Monopex) drops for one week Preservative free Diklofenak 1mg/mL drops (Voltaren minims) four times a day from three days before surgery.
After surgery:
Lubricants (Thealoz Duo) for three weeks. Preservative free dexamethasone 0.1% (Monopex) drops for three weeks. Preservative free Diklofenak 1mg/mL drops (Voltaren minims) for five days after surgery.
Biometry will be performed prior to and after the preoperative treatment, 6 weeks after surgery.
The variability in biometry measurements will be assessed for the standard protocol group versus the intensive dry eye protocol group. In addition, the average difference in estimated refraction and the actual refractive outcome (deltaR) will be calculated for both groups.
Differences in tear film instability before and after preoperative treatment, 6 weeks after surgery will be investigated.
Other variables to be investigated:
Average corneal curvature (K) Anterior corneal curvature Corneal astigmatism Mean spherical equivalent Dioptric keratometric power (estimated Intraocular lens (IOL) power) Best corrected visual acuity Tearlab osmolarity Non-invasive break up time(NIBUT) Tear meniscus height Bulbar redness grade Tear film lipid layer thickness (Lipiview) Ocular scatter analysis (HD analyzer) Cochet-Bonnet esthesiometry Ocular surface staining(OSS) Schirmers I test (without anesthetics) Meibum expressibility Meibum quality Meibomian gland dropout (meibography) Lid margin irregularities (yes/no) Tarsal conjunctival follicles/papillae (yes/no) Ocular surface disease index(OSDI) Dry Eye Quality of life questionnaire-5 (DEQ-5) Standard Patient Evaluation of Eye Dryness II (SPEED II)
- Conditions
- Dry Eye Syndromes, Cataract
- Being tested
- Lubricant Eye Drops, Preservative Free, Preservative
- Keywords
- Metabolomics, Dry Eye Syndrome, Cataract surgery
- Medical subject headings
- Dry Eye Syndromes, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lubricant Eye DropsDrug
Prolonged use of lubricant eye drops pre and post-op.
Preservative FreeDrug
Preservative free eye drops
PreservativeDrug
Eyedrops with preservatives
| Study group | Role | What they receive |
|---|---|---|
| Cataract patients with dry eye - standard treatment | Experimental | Standard pre and postop medication, preservative eye drops. Receives: Drug: Preservative |
| Cataract patients with dry eye - intensive treatment | Other | More prolonged use of lubricant eye drops as well as the use of preservative free eye drops. Receives: Drug: Lubricant Eye Drops; Drug: Preservative Free |
| Cataract patients without dry eye disease / control group | Other | Standard pre and postop medication, control group. Receives: Drug: Preservative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomic and lipodomic profile
The metabolomic and lipodomic profiles of the tears in each group will be measured. Relevant metabolic/lipid results will be reported.
Measured: 6 weeks
Secondary outcomes (2)
Spherical equivalent refraction
Spherical equivalent refraction in diopters.
Measured: 6 weeks
Refractive cylinder
Refractive cylinder in diopters.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start3 Aug 2020
- Primary completion10 Jan 2023 (estimated)
- Study completion23 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ifocus Oyeklinikk
- Sponsor type
- Research network
- Collaborators
- The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Morten Gundersen, MD, Principal investigator, IFocus Øyeklinikk AS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433428
- Sponsor's protocol ID
- 140664
- Status last verified
- Jun 2022
- First submitted
- 10 Aug 2020
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic Profile in Tear Film Samples of Patients With or Without Dry Eye Syndrome Before and After Cataract Surgery.
- ClinicalTrials.gov ID
- NCT05433428
- Acronym / sponsor ID
- 140664
- Conditions
- Dry Eye Syndromes, Cataract
- Keywords
- Metabolomics, Dry Eye Syndrome, Cataract surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Ifocus OyeklinikkResearch network
- Collaborators
- The Research Council of Norway
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 10 Jan 2023 (estimated)
- Study completion
- 23 May 2023 (estimated)
- First posted
- 27 Jun 2022 (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.
The primary objective is to determine possible implications of deviant tear film quality for optimal refractive precision in patients scheduled for cataract surgery.
The study consist of three separate arms where cataract patients will be separated in to Dry Eye Disease (DED) positive and negative groups. The DED positive group will be further subdivided into two different treatment groups (with focus on prolonged use of lubricant and preservative free eye drops). Tear film samples will be taken before treatment, after treatment and after surgical treatment and compared.
Detailed description
The participants will be randomized to either standard pre- and postoperative treatment protocol - hereby called the standard protocol - or a pre- and postoperative protocol where intensive dry eye treatment is implemented - hereby called the intensive dry eye treatment protocol. The intensive dry eye treatment protocol differs from the standard protocol in the use of preservative free eye drops and the use of topical steroids prior to surgery.
The standard treatment protocol is:
Before surgery:
- Nevanac 3 mg /mL
- Spersadex 1mg/ml three days before surgery.
After surgery:
Nevanac 3 mg /mL five days after surgery. Spersadex 1 mg/ml 20 days after surgery
The intensive dry eye treatment protocol is:
Before surgery:
Lubricants (Thealoz Duo) for four weeks. Preservative free dexamethasone 0.1% (Monopex) drops for one week Preservative free Diklofenak 1mg/mL drops (Voltaren minims) four times a day from three days before surgery.
After surgery:
Lubricants (Thealoz Duo) for three weeks. Preservative free dexamethasone 0.1% (Monopex) drops for three weeks. Preservative free Diklofenak 1mg/mL drops (Voltaren minims) for five days after surgery.
Biometry will be performed prior to and after the preoperative treatment, 6 weeks after surgery.
The variability in biometry measurements will be assessed for the standard protocol group versus the intensive dry eye protocol group. In addition, the average difference in estimated refraction and the actual refractive outcome (deltaR) will be calculated for both groups.
Differences in tear film instability before and after preoperative treatment, 6 weeks after surgery will be investigated.
Other variables to be investigated:
Average corneal curvature (K) Anterior corneal curvature Corneal astigmatism Mean spherical equivalent Dioptric keratometric power (estimated Intraocular lens (IOL) power) Best corrected visual acuity Tearlab osmolarity Non-invasive break up time(NIBUT) Tear meniscus height Bulbar redness grade Tear film lipid layer thickness (Lipiview) Ocular scatter analysis (HD analyzer) Cochet-Bonnet esthesiometry Ocular surface staining(OSS) Schirmers I test (without anesthetics) Meibum expressibility Meibum quality Meibomian gland dropout (meibography) Lid margin irregularities (yes/no) Tarsal conjunctival follicles/papillae (yes/no) Ocular surface disease index(OSDI) Dry Eye Quality of life questionnaire-5 (DEQ-5) Standard Patient Evaluation of Eye Dryness II (SPEED II)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cataract patients with dry eye - standard treatment | Experimental | Drug: PreservativeStandard pre and postop medication, preservative eye drops. |
| Cataract patients with dry eye - intensive treatment | Other | Drug: Lubricant Eye Drops, Drug: Preservative FreeMore prolonged use of lubricant eye drops as well as the use of preservative free eye drops. |
| Cataract patients without dry eye disease / control group | Other | Drug: PreservativeStandard pre and postop medication, control group. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Indication for cataract surgery
- Signed informed consent
- no rheumatological or other systemic disease that involve the corneal surface
- a good ocular health with no pathology that compromises visual acuity (except cataract).
Key exclusion criteria (9 listed)
- Manifest corneal disease or scarring
- Lid deformities
- Corneal ectasia
- Rheumatoid diseases or other systemic diseases that involve the corneal surface,
- Recent ocular surgery
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 |
|---|---|---|
| Lubricant Eye DropsProlonged use of lubricant eye drops pre and post-op. | Drug | Cataract patients with dry eye - intensive treatment |
| Preservative FreePreservative free eye drops | Drug | Cataract patients with dry eye - intensive treatment |
| PreservativeEyedrops with preservatives | Drug | Cataract patients with dry eye - standard treatment, Cataract patients without dry eye disease / control group |
Primary outcome
Metabolomic and lipodomic profile
Time frame: 6 weeks
The metabolomic and lipodomic profiles of the tears in each group will be measured. Relevant metabolic/lipid results will be reported.
2 secondary outcomes
Spherical equivalent refraction
Time frame: 6 weeks
Refractive cylinder
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Morten Gundersen, MD principal investigator
IFocus Øyeklinikk AS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lubricant Eye Drops, Preservative Free and Preservative in people with Dry Eye Syndromes and Cataract, run by Ifocus Oyeklinikk at 1 site in Norway.
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 4 inclusion and 9 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 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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 Morten Gundersen, MD (+4748157846, morten@ifocus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolomic and lipodomic profile (time frame: 6 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 27 Jun 2022.