Dry Eye Due to Sjögren's SyndromePhase 4NCT03319420
Evaluate the Efficacy and Safety of LO2A Eye Drops for Symptomatic Improvement of Dry Eye in Patients With Sjögren's Syndrome
A Phase 4 study testing LO2A eye drops and Systane Ultra UD in people with Dry Eye Due to Sjögren's Syndrome, run by Ocuwize LTD at 5 sites in Israel.
Trial summary
Dry eye complaints occur in 5.5 to 33.7% of the population, and are ranked as the most frequent symptoms of patients visiting ophthalmologists. Dry eye syndrome is caused by the reduced production and/or improper quality of the tear film. One of the causes of reduced tear production is Sjögren's syndrome. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Dry Eye Due to Sjögren's Syndrome
- What is being tested?
- LO2A eye drops and Systane Ultra UD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesIsrael
- Study dates
- 29 Mar 2018to 1 Jan 2021
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female of any race and ≥ 18 years of age.
- Willing and able to provide voluntary written informed consent.
- Primary or secondary Sjögren's syndrome according to the American- European Consensus Classification Criteria (2002).
- Females of childbearing potential must agree to use effective contraception consistently throughout the study (such as hormonal contraception or two forms of barrier contraception) and have a negative urine pregnancy test at screening.
- Willing and able to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- Subject has concurrent, uncontrolled medical condition, or psychiatric illness which could place him/her at unacceptable risk.
- Subjects with pterygium.
- Subjects with active, allergic keratoconjunctivitis, or conjunctivitis of infectious origin.
- Subjects with blepharitis requiring treatment.
- Subjects with a history of surgery affecting the eye surface, as well as eye injuries within 3 months of screening.
- Subjects currently using any topical ophthalmic treatment (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial.
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- Female subjects who are pregnant or breast-feeding, or plan to become pregnant during the study.
- Subjects that have started or changed the dose of chronic systemic medication within 7 days of Visit 1.
- Known hypersensitivity to sodium hyaluronate or any LO2A excipients (glycerol and Carbomer 981) or any of the components in Systane Ultra UD.
- Active abuse of alcohol or drugs.
- Any condition, which in the opinion of the Investigator, would place the patient at an unacceptable risk if participating in the study protocol.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Israel5 sites
HaEmek MC
Afula
Rambam
Haifa
Rabin MC
Petah Tikva
Kaplan MC
Rehovot
Ichilov medical center Tel Aviv
Tel Aviv
About this study
Official title: A Randomized, Double-Masked, Comparative Study Versus Systane Ultra UD, to Evaluate the Efficacy and Safety of LO2A Eye Drops for Symptomatic Improvement of Dry Eye in Patients With Sjögren's Syndrome
Dry eye complaints occur in 5.5 to 33.7% of the population, and are ranked as the most frequent symptoms of patients visiting ophthalmologists. Dry eye syndrome is caused by the reduced production and/or improper quality of the tear film. One of the causes of reduced tear production is Sjögren's syndrome. Sjögren's is estimated to affect up to 4 million patients in the US alone. It affects mostly middle aged women (40-50 years of age) with a female to male prevalence ratio of 9:1.
The current study seeks to evaluate the safety and efficacy of LO2A ophthalmic solution in the symptomatic treatment of dry eye in patients with Sjögren's syndrome. This study will be conducted in compliance with the protocol, GCP,and applicable regulatory requirements.
Read the detailed description
This is a randomized, double-masked, comparative study versus Systane ultra UD, to evaluate the efficacy and safety of LO2A eye drops for symptomatic improvement of dry eye in Patients with Sjögren's syndrome. Eligible patients will be randomly assigned in a 1:1 ratio to one of two treatment groups, LO2A or Systane ultra UD, respectively.
The study will consist of a screening period of up to two weeks and a 3-month double blind treatment period (topical application of eye drops four times daily)
Up to 60 subjects are planned to be recruited to this study, randomized to one of two treatment arms using a 1:1 active (LO2A) to Systane ultra UD ratio.
- Conditions
- Dry Eye Due to Sjögren's Syndrome
- Being tested
- LO2A eye drops, Systane Ultra UD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LO2A eye dropsDrug
Sodium hyaluronate
Systane Ultra UDDrug
Active Ingredients; Polyethylene Glycol Propylene Glycol
| Study group | Role | What they receive |
|---|---|---|
| LO2A | Experimental | 1 drop of sodium hyaluronate instilled into each eye 4 times daily Receives: Drug: LO2A eye drops |
| Systane Ultra UD | Active comparator | 1 drop of Systane Ultra UD instilled into each eye 4 times daily Receives: Drug: Systane Ultra UD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in corneal / conjunctival staining score using the National Eye Institute/Industry(NEI) Industry Grading System
NEI/Industry Workshop Conjunctival Staining Grading System. Devitalized epithelial cells of the bulbar conjunctiva are stained with lissamine green and can graded across six zones The scores for each zone (0-3) are summed to obtain an overall score for each eye (0-18.( The higher the results, the more severe the dryness of the eye.
Measured: 3 months form the basline
Secondary outcomes (2)
Change in Ocular Surface Disease Index (OSDI) questionnaire 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 and 3 months from the basline visit
Change in corneal / conjunctival staining score using the National Eye Institute/Industry(NEI) Industry Grading System
NEI/Industry Workshop Conjunctival Staining Grading System. Devitalized epithelial cells of the bulbar conjunctiva are stained with lissamine green and can graded across six zones The scores for each zone (0-3) are summed to obtain an overall score for each eye (0-18.( The higher the results, the more severe the dryness of the eye.
Measured: After one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start29 Mar 2018
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Due to Sjögren's SyndromeStudies 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
- Model description
- A randomized, double-Masked, comparative study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocuwize LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319420
- Sponsor's protocol ID
- WP-LO2A-03
- Status last verified
- Jul 2019
- First submitted
- 19 Oct 2017
- Last updated
- 25 Feb 2021
- 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 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked, Comparative Study Versus Systane Ultra UD, to Evaluate the Efficacy and Safety of LO2A Eye Drops for Symptomatic Improvement of Dry Eye in Patients With Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT03319420
- Acronym / sponsor ID
- WP-LO2A-03
- Conditions
- Dry Eye Due to Sjögren's Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ocuwize LTDIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 24 Oct 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.
Dry eye complaints occur in 5.5 to 33.7% of the population, and are ranked as the most frequent symptoms of patients visiting ophthalmologists. Dry eye syndrome is caused by the reduced production and/or improper quality of the tear film. One of the causes of reduced tear production is Sjögren's syndrome. Sjögren's is estimated to affect up to 4 million patients in the US alone. It affects mostly middle aged women (40-50 years of age) with a female to male prevalence ratio of 9:1.
The current study seeks to evaluate the safety and efficacy of LO2A ophthalmic solution in the symptomatic treatment of dry eye in patients with Sjögren's syndrome. This study will be conducted in compliance with the protocol, GCP,and applicable regulatory requirements.
Detailed description
This is a randomized, double-masked, comparative study versus Systane ultra UD, to evaluate the efficacy and safety of LO2A eye drops for symptomatic improvement of dry eye in Patients with Sjögren's syndrome. Eligible patients will be randomly assigned in a 1:1 ratio to one of two treatment groups, LO2A or Systane ultra UD, respectively.
The study will consist of a screening period of up to two weeks and a 3-month double blind treatment period (topical application of eye drops four times daily)
Up to 60 subjects are planned to be recruited to this study, randomized to one of two treatment arms using a 1:1 active (LO2A) to Systane ultra UD ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, double-Masked, comparative study
| Arm | Type | Receives |
|---|---|---|
| LO2A | Experimental | Drug: LO2A eye drops1 drop of sodium hyaluronate instilled into each eye 4 times daily |
| Systane Ultra UD | Active comparator | Drug: Systane Ultra UD1 drop of Systane Ultra UD instilled into each eye 4 times daily |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female of any race and ≥ 18 years of age.
- Willing and able to provide voluntary written informed consent.
- Primary or secondary Sjögren's syndrome according to the American- European Consensus Classification Criteria (2002).
- Females of childbearing potential must agree to use effective contraception consistently throughout the study (such as hormonal contraception or two forms of barrier contraception) and have a negative urine pregnancy test at screening.
- Willing and able to adhere to the study visit schedule and other protocol requirements.
Key exclusion criteria (11 listed)
- Subject has concurrent, uncontrolled medical condition, or psychiatric illness which could place him/her at unacceptable risk.
- Subjects with pterygium.
- Subjects with active, allergic keratoconjunctivitis, or conjunctivitis of infectious origin.
- Subjects with blepharitis requiring treatment.
- Subjects with a history of surgery affecting the eye surface, as well as eye injuries within 3 months of screening.
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 |
|---|---|---|
| LO2A eye dropsSodium hyaluronate | Drug | LO2A |
| Systane Ultra UDActive Ingredients; Polyethylene Glycol Propylene Glycol | Drug | Systane Ultra UD |
Primary outcome
Change in corneal / conjunctival staining score using the National Eye Institute/Industry(NEI) Industry Grading System
Time frame: 3 months form the basline
NEI/Industry Workshop Conjunctival Staining Grading System. Devitalized epithelial cells of the bulbar conjunctiva are stained with lissamine green and can graded across six zones The scores for each zone (0-3) are summed to obtain an overall score for each eye (0-18.( The higher the results, the more severe the dryness of the eye.
2 secondary outcomes
Change in Ocular Surface Disease Index (OSDI) questionnaire score.
Time frame: 1 and 3 months from the basline visit
Change in corneal / conjunctival staining score using the National Eye Institute/Industry(NEI) Industry Grading System
Time frame: After one 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 25 Feb 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 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 LO2A eye drops and Systane Ultra UD in people with Dry Eye Due to Sjögren's Syndrome, run by Ocuwize LTD at 5 sites in Israel.
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 5 inclusion and 11 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 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel. 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?
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?
Change in corneal / conjunctival staining score using the National Eye Institute/Industry(NEI) Industry Grading System (time frame: 3 months form the basline). 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 25 Feb 2021.