Dry EyeNCT03833908
Evaluation of the Performance of MAF-1217 on Cataract Surgery
A study testing MAF-1217 in people with Dry Eye, run by VISUfarma SpA at 2 sites in Italy.
Trial summary
MAF-1217 is meant as the medical device which is to be effective in most forms of DED; therefore, it is expected that study patients benefit from study participation, and can reduce the signs and symptoms of surgery induced DED in patients undergoing cataract surgery, in a TID application pre-surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- MAF-1217
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesItaly
- Study dates
- 20 Nov 2018to 17 Jun 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old patients, male and female
- Patients without diagnosed DED (including subclinical DED) or with mild DED, with BUT >7
- Normal to mild DED according to OSDI chart
- Diagnosis of Cataract requiring surgery
- Wishing to participate in the study and able to sign the ICF
- Shirmer test > 15 mm /5'
- No topic ophthalmic medication, including lubricating eyedrops administration for at least 4 days before screening visit.
Who cannot join
- Neuropathic causes of dry eye (diabetes, long-standing contact lens wearing, previous ocular herpes infections)
- Patients with diagnosis of Glaucoma
- Functional and anatomic eyelid abnormalities,
- Complicated cataract,
- Suture affixing during surgery,
- Use of artificial tears in the month preceding the study visit
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- Coexisting corneal diseases
- Autoimmune diseases
- Past or active cicatricial conjunctivitis
- Past ocular surface burns
- Keratinization of the eyelid margin
- Sjogren syndrome
- History of corneal trauma
- Pregnant and lactating women
- Younger than 18 years old patients
- Inability to self-administer study medications
- Known allergic sensitivity to any of the devices ingredients, or any other type of allergy
- Participation in a clinical trial during the 3 months prior to the beginning of the study
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Università di Firenze, Clinica Oculistica II,
Florence, 50134
Ospedale San Paolo, ASST Santi Paolo e Carlo
Milan, 20121
About this study
Official title: Evaluation of the Performance of MAF-1217 on Surgery Induced DED When Administered Pre-operatively in Patients Undergoing Cataract Surgery
MAF-1217 is meant as the medical device which is to be effective in most forms of DED; therefore, it is expected that study patients benefit from study participation, and can reduce the signs and symptoms of surgery induced DED in patients undergoing cataract surgery, in a TID application pre-surgery.
Read the detailed description
This is a multicentre, pre-market, open label, randomized, prospective study exploring the performance of MAF-1217 when administered pre-surgery, in reducing the sign and symptoms of post-surgery DED in patients undergoing cataract surgery. Patients will be enrolled 2 weeks before Surgery (screening visit), will undergo cataract surgery (Day 0 - Baseline/Surgery), and then will be seen at week 1 and 2 after surgery.
- Conditions
- Dry Eye
- Being tested
- MAF-1217
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAF-1217Device
Patients will be enrolled at screening (2 weeks before surgery), then will be randomized with a 1:1 ratio to 2 groups of 23 patients each: A. patients receiving MAF-1217 B. patients receiving just standard antibiotic therapy
| Study group | Role | What they receive |
|---|---|---|
| patients receiving MAF-1217 | Experimental | patients receiving MAF-1217 from week -2 to week 2 (preand post-surgery, total 4 weeks), standard antibiotic therapy (ofloxacin) from day -3 before surgery, and standard postoperative treatment (topical steroid, dexamethasone for 10 days + antibiotic, ofloxacin for 7 days) from day 0 (post-surgery. Receives: Device: MAF-1217 |
| patients receiving just standard antibiotic therapy | No intervention | patients receiving just standard antibiotic therapy (ofloxacin) from day -3 before surgery, and standard postoperative treatment (topical steroid, dexamethasone for 10 days + antibiotic, ofloxacin 7 days) from day 0 (postsurgery). |
What is being measured
The primary outcome is the main question the study is designed to answer.
break-up time (BUT)
Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in break-up time (BUT)
Measured: 1 month
Secondary outcomes (3)
osmolarity
Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in osmolarity
Measured: 1 month
OSDI score
Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in OSDI score.
The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease.
Measured: 1 month
Schirmer test I
Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in Schirmer test I (test uses paper strips inserted into the eye for several minutes to measure the production of tears)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start20 Nov 2018
- Primary completion17 Jun 2019
- Study completion17 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- VISUfarma SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833908
- Sponsor's protocol ID
- VF-OS-002/2018
- Status last verified
- Jul 2019
- First submitted
- 31 Jan 2019
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fogagnolo P, Favuzza E, Marchina D, Cennamo M, Vignapiano R, Quisisana C, Rossetti L, Mencucci R. New Therapeutic Strategy and Innovative Lubricating Ophthalmic Solution in Minimizing Dry Eye Disease Associated with Cataract Surgery: A Randomized, Prospective Study. Adv Ther. 2020 Apr;37(4):1664-1674. doi: 10.1007/s12325-020-01288-z. Epub 2020 Mar 17.
PubMed 32185729
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of MAF-1217 on Surgery Induced DED When Administered Pre-operatively in Patients Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT03833908
- Acronym / sponsor ID
- VF-OS-002/2018
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- VISUfarma SpAIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 17 Jun 2019 (actual)
- Study completion
- 17 Jun 2019 (actual)
- First posted
- 7 Feb 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.
MAF-1217 is meant as the medical device which is to be effective in most forms of DED; therefore, it is expected that study patients benefit from study participation, and can reduce the signs and symptoms of surgery induced DED in patients undergoing cataract surgery, in a TID application pre-surgery.
Detailed description
This is a multicentre, pre-market, open label, randomized, prospective study exploring the performance of MAF-1217 when administered pre-surgery, in reducing the sign and symptoms of post-surgery DED in patients undergoing cataract surgery. Patients will be enrolled 2 weeks before Surgery (screening visit), will undergo cataract surgery (Day 0 - Baseline/Surgery), and then will be seen at week 1 and 2 after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients receiving MAF-1217 | Experimental | Device: MAF-1217patients receiving MAF-1217 from week -2 to week 2 (preand post-surgery, total 4 weeks), standard antibiotic therapy (ofloxacin) from day -3 before surgery, and standard postoperative treatment (topical steroid, dexamethasone for 10 days + antibiotic, ofloxacin for 7 days) from day 0 (post-surgery. |
| patients receiving just standard antibiotic therapy | No intervention | –patients receiving just standard antibiotic therapy (ofloxacin) from day -3 before surgery, and standard postoperative treatment (topical steroid, dexamethasone for 10 days + antibiotic, ofloxacin 7 days) from day 0 (postsurgery). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years old patients, male and female
- Patients without diagnosed DED (including subclinical DED) or with mild DED, with BUT >7
- Normal to mild DED according to OSDI chart
- Diagnosis of Cataract requiring surgery
- Wishing to participate in the study and able to sign the ICF
Key exclusion criteria (18 listed)
- Neuropathic causes of dry eye (diabetes, long-standing contact lens wearing, previous ocular herpes infections)
- Patients with diagnosis of Glaucoma
- Functional and anatomic eyelid abnormalities,
- Complicated cataract,
- Suture affixing during 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 |
|---|---|---|
| MAF-1217Patients will be enrolled at screening (2 weeks before surgery), then will be randomized with a 1:1 ratio to 2 groups of 23 patients each: A. patients receiving MAF-1217 B. patients receiving just standard antibiotic therapy | Device | patients receiving MAF-1217 |
Primary outcome
break-up time (BUT)
Time frame: 1 month
Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in break-up time (BUT)
3 secondary outcomes
osmolarity
Time frame: 1 month
OSDI score
Time frame: 1 month
Schirmer test I
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Derived from this study: PubMed 32185729Fogagnolo P, Favuzza E, Marchina D, Cennamo M, Vignapiano R, Quisisana C, Rossetti L, Mencucci R. New Therapeutic Strategy and Innovative Lubricating Ophthalmic Solution in Minimizing Dry Eye Disease Associated with Cataract Surgery: A Randomized, Prospective Study. Adv Ther. 2020 Apr;37(4):1664-1674. doi: 10.1007/s12325-020-01288-z. Epub 2020 Mar 17.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAF-1217 in people with Dry Eye, run by VISUfarma SpA at 2 sites in Italy.
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 7 inclusion and 18 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: finished, as of the sponsor's last update on 15 Jul 2019. 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 Italy. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
break-up time (BUT) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03833908, which also lists 1 linked publication.
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 15 Jul 2019.