Dry Eye SyndromesNCT03140111
LAMELLEYE for the Treatment of Dry Eye Symptoms in pSS Patients
A study testing LAMELLEYE and OPTIVE FUSION in people with Dry Eye Syndromes and Primary Sjögren Syndrome, run by NHS Greater Glasgow and Clyde.
Trial summary
Single-blind, randomised, single centre, 2-way crossover pilot study to investigate the effectiveness of LAMELLEYE for the treatment of dry eye symptoms in patients with primary Sjögren's Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Dry Eye Syndromes, Primary Sjögren Syndrome
- What is being tested?
- LAMELLEYE and OPTIVE FUSION
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 16 Oct 2017to 30 Mar 2018
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for inclusion, each Participant must meet each of the following:
- Male or female aged ≥ 18 years and ≤ 79 years at date of consent
- Primary Sjögren's Syndrome diagnosed by a rheumatologist
- Patient has symptoms of dry eye, and has failed to achieve symptom relief on adequate trial of standard topical therapy
- Willing and able to attend Glasgow Caledonian University Vision Sciences Eye Clinic for therapy assessment; and to comply with all procedures and follow-up visits
- Participant must have personally given written informed consent to allow anonymised data to be used in publications and presentations.
Who cannot join
- Participants are excluded from the study if any of the following criteria are met:
- Females who are pregnant, planning pregnancy or breastfeeding
- Active ocular infection or current corneal ulceration
- Ocular surgery within 6 months of study start date
- Current contact lens wear
- Any prior and/or current topical ophthalmic treatments that in the opinion of the CI or PI may interfere with the study outcomes
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- Started or changed the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, anticholinergics, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days prior to enrolment
- Participants with known allergies to ingredients in any of the study treatments, or fluorescein
- Participants who are judged inappropriate for inclusion in the study by the CI or PI.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Post-approval Study to Assess the Effectiveness of LAMELLEYE vs Comparator for the Treatment of Dry Eye Symptoms in Patients With Primary Sjögren's Syndrome
Single-blind, randomised, single centre, 2-way crossover pilot study to investigate the effectiveness of LAMELLEYE for the treatment of dry eye symptoms in patients with primary Sjögren's Syndrome.
Read the detailed description
The study is a 2-way crossover design comprising 2 treatments: the CE-marked LAMELLEYE dry eye drops, and a CE-marked comparator product. All Participants will be allocated to a treatment group in a random order.
The study design allows observations to be made between the treatments at both an intra- and inter-patient level regarding relationships between the patient's disease specific quality of life, symptoms and adverse events, and satisfaction with treatments.
- Conditions
- Dry Eye Syndromes, Primary Sjögren Syndrome
- Being tested
- LAMELLEYE, OPTIVE FUSION
- 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.
LAMELLEYEDevice
Also called CXB/1-14
Liposomal multi-dose preservative-free sterile suspension which contains soy lecithin phospholipids, sphingomyelin and cholesterol, suspended in saline.
OPTIVE FUSIONDevice
Multi-dose sterile solution which contains sodium hyaluronate 0.1%, sodium carboxymethylcellulose 0.5%, glycerine 0.9%, erythritol, boric acid, sodium citrate dihydrate, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, and is preserved with PURITE® 0.01% which breaks down into natural tear components on the eye.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A, followed by Treatment B | Other | Treatment group that will receive Treatment A for 28 days, followed by Treatment B for 28 days. There will be a minimum 7 day washout between Treatments. LAMELLEYE Dry Eye Drops and OPTIVE FUSION will be administered to all subjects in this arm. Treatments will be self-administered at least 3 times a day. Receives: Device: LAMELLEYE; Device: OPTIVE FUSION |
| Treatment B, followed by Treatment A | Other | Treatment group that will receive Treatment B for 28 days, followed by Treatment A for 28 days. There will be a minimum 7 day washout between Treatments. LAMELLEYE Dry Eye Drops and OPTIVE FUSION will be administered to all subjects in this arm. Treatments will be self-administered at least 3 times a day. Receives: Device: LAMELLEYE; Device: OPTIVE FUSION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported symptoms
Ocular Surface Disease Index (OSDI):
12-item questionnaire designed to assess the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning
and Symptom Assessment in Dry Eye (SANDE): Two questions which each use a horizontal visual analogue technique to quantify patient symptomatology of dryness and/or irritation
Measured: 28 days (analysed for each treatment period)
Patient reported quality of life
Impact of Dry Eye Disease on Everyday Life (IDEEL - copyright Novartis Pharma AG):
The use of this questionnaire (Treatment Satisfaction module only) will provide assessment of the impact of study treatment on patient outcomes in this study.
Measured: 28 days (analysed for each treatment period)
Secondary outcomes (6)
Non-invasive tear break-up time (NITBUT)
Measure of time taken from blink to breakup of tear film
Measured: 28 days (analysed for each treatment period)
Evaporimetry
Measure of the rate of evaporation of the tear film from the surface of the eye
Measured: 28 days (analysed for each treatment period)
Interferometry
Tear film lipid layer interferometry is a test to study the structure and quality of the lipid layer in the tear film
Measured: 28 days (analysed for each treatment period)
Osmolarity
Tear osmolarity is a test to determine the solute concentration of the tear film
Measured: 28 days (analysed for each treatment period)
Corneal and Conjunctival Staining
Corneal and conjunctival damage due to dry eye can be measured by staining the surface of the eye with fluorescein and examining under a lamp with a cobalt blue filter
Measured: 28 days (analysed for each treatment period)
Inflammatory markers
Cytokine analysis will be carried out to determine the presence and concentration of a panel of inflammatory biomarkers in the tears using a multiplex immunoassay
Measured: 28 days (analysed for each treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start16 Oct 2017 (estimated)
- Primary completion30 Mar 2018 (estimated)
- Study completion30 Mar 2018 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- Lamellar Biomedical Ltd, Robertson Centre for Biostatistics - University of Glasgow, Glasgow Caledonian University
- Responsible party
- Sponsor
- Investigators
- Monica Gupta, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140111
- Sponsor's protocol ID
- GN16HS410
- Other IDs
- 001172
- Status last verified
- Sep 2017
- First submitted
- 2 May 2017
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-approval Study to Assess the Effectiveness of LAMELLEYE vs Comparator for the Treatment of Dry Eye Symptoms in Patients With Primary Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT03140111
- Acronym / sponsor ID
- GN16HS410
- Conditions
- Dry Eye Syndromes, Primary Sjögren Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- Lamellar Biomedical Ltd, Robertson Centre for Biostatistics - University of Glasgow, Glasgow Caledonian University
- Study start
- 16 Oct 2017 (estimated)
- Primary completion
- 30 Mar 2018 (estimated)
- Study completion
- 30 Mar 2018 (estimated)
- First posted
- 4 May 2017 (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.
Single-blind, randomised, single centre, 2-way crossover pilot study to investigate the effectiveness of LAMELLEYE for the treatment of dry eye symptoms in patients with primary Sjögren's Syndrome.
Detailed description
The study is a 2-way crossover design comprising 2 treatments: the CE-marked LAMELLEYE dry eye drops, and a CE-marked comparator product. All Participants will be allocated to a treatment group in a random order.
The study design allows observations to be made between the treatments at both an intra- and inter-patient level regarding relationships between the patient's disease specific quality of life, symptoms and adverse events, and satisfaction with treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A, followed by Treatment B | Other | Device: LAMELLEYE, Device: OPTIVE FUSIONTreatment group that will receive Treatment A for 28 days, followed by Treatment B for 28 days. There will be a minimum 7 day washout between Treatments. LAMELLEYE Dry Eye Drops and OPTIVE FUSION will be administered to all subjects in this arm. Treatments will be self-administered at least 3 times a day. |
| Treatment B, followed by Treatment A | Other | Device: LAMELLEYE, Device: OPTIVE FUSIONTreatment group that will receive Treatment B for 28 days, followed by Treatment A for 28 days. There will be a minimum 7 day washout between Treatments. LAMELLEYE Dry Eye Drops and OPTIVE FUSION will be administered to all subjects in this arm. Treatments will be self-administered at least 3 times a day. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female aged ≥ 18 years and ≤ 79 years at date of consent
- Primary Sjögren's Syndrome diagnosed by a rheumatologist
- Patient has symptoms of dry eye, and has failed to achieve symptom relief on adequate trial of standard topical therapy
- Willing and able to attend Glasgow Caledonian University Vision Sciences Eye Clinic for therapy assessment; and to comply with all procedures and follow-up visits
- Participant must have personally given written informed consent to allow anonymised data to be used in publications and presentations.
Key exclusion criteria (9 listed)
- Females who are pregnant, planning pregnancy or breastfeeding
- Active ocular infection or current corneal ulceration
- Ocular surgery within 6 months of study start date
- Current contact lens wear
- Any prior and/or current topical ophthalmic treatments that in the opinion of the CI or PI may interfere with the study outcomes
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 |
|---|---|---|
| LAMELLEYEAlso: CXB/1-14Liposomal multi-dose preservative-free sterile suspension which contains soy lecithin phospholipids, sphingomyelin and cholesterol, suspended in saline. | Device | Treatment A, followed by Treatment B, Treatment B, followed by Treatment A |
| OPTIVE FUSIONMulti-dose sterile solution which contains sodium hyaluronate 0.1%, sodium carboxymethylcellulose 0.5%, glycerine 0.9%, erythritol, boric acid, sodium citrate dihydrate, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, and is preserved with PURITE® 0.01% which breaks down into natural tear components on the eye. | Device | Treatment A, followed by Treatment B, Treatment B, followed by Treatment A |
Primary outcome
Patient reported symptoms
Time frame: 28 days (analysed for each treatment period)
Ocular Surface Disease Index (OSDI): 12-item questionnaire designed to assess the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning and Symptom Assessment in Dry Eye (SANDE): Two questions which each use a horizontal visual analogue technique to quantify patient symptomatology of dryness and/or irritation
Patient reported quality of life
Time frame: 28 days (analysed for each treatment period)
Impact of Dry Eye Disease on Everyday Life (IDEEL - copyright Novartis Pharma AG): The use of this questionnaire (Treatment Satisfaction module only) will provide assessment of the impact of study treatment on patient outcomes in this study.
6 secondary outcomes
Non-invasive tear break-up time (NITBUT)
Time frame: 28 days (analysed for each treatment period)
Evaporimetry
Time frame: 28 days (analysed for each treatment period)
Interferometry
Time frame: 28 days (analysed for each treatment period)
Osmolarity
Time frame: 28 days (analysed for each treatment period)
Corneal and Conjunctival Staining
Time frame: 28 days (analysed for each treatment period)
Inflammatory markers
Time frame: 28 days (analysed for each treatment period)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- 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.
Monica Gupta principal investigator
NHS Greater Glasgow and Clyde
Questions about this trial
What is this clinical trial studying?
A study testing LAMELLEYE and OPTIVE FUSION in people with Dry Eye Syndromes and Primary Sjögren Syndrome, run by NHS Greater Glasgow and Clyde.
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 6 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 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susan Clark (01698 748 832, SC@lamellar.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported symptoms (time frame: 28 days (analysed for each treatment period)). The study lists 2 primary outcomes in all. 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 11 Sep 2017.