Dry EyePhase 4NCT02951910
A Study of the Effect of Zinc-Hyaluronate on Ocular Surface Sensations in Patients With Dry Eye
A Phase 4 study testing Ophylosa tear supplement in people with Dry Eye, run by Semmelweis University.
Trial summary
Hyaluronic acid, a natural polymer, helps to maintain ocular surface hydration and can already be found in several artificial tears recommended to alleviate symptoms of dry eye. A recent hyaluronate modification involves zinc-hyaluronate complex formation by adding zinc-chloride to an aqueous sodium-hyaluronate… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Ophylosa tear supplement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Oct 2016
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who had been diagnosed as having dry eye symptoms for at least 3 months, with an OSDI score of ≥13 evaluated by the questionnaire of Ocular Surface Disease Index (OSDI)
Who cannot join
- Subjects with ophthalmic conditions other than dry eye or systemic disease including blepharitis, meibomitis, lid abnormalities as well as contact lens wearers
About this study
Hyaluronic acid, a natural polymer, helps to maintain ocular surface hydration and can already be found in several artificial tears recommended to alleviate symptoms of dry eye. A recent hyaluronate modification involves zinc-hyaluronate complex formation by adding zinc-chloride to an aqueous sodium-hyaluronate resulting in a very stable molecular structure, which functions as both a mechanical barrier and a biocompatible film on the ocular surface. Apart from its beneficial elastoviscous characteristics, previous results indicate that hyaluronate can also reduce the excitability of the peripheral nociceptor endings underlying pain. Although hyaluronate is widely used in artificial tears to improve tear film stability, its effect on ocular surface sensitivity was not evaluated in patients with dry eye. The aim of this study is to investigate the characteristics of ocular surface sensations and corneal sensitivity in dry eye patients before and after long-term tear supplementation with zinc-hyaluronate.
- Conditions
- Dry Eye
- Being tested
- Ophylosa tear supplement
- 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.
Ophylosa tear supplementDevice
Tear film dynamics is assessed by non-invasive tear film breakup time (NI-BUT) in parallel with continuous recordings of ocular sensations during forced blinking. Corneal sensitivity thresholds to selective stimulation of corneal mechanonociceptors, thermal receptors and chemical nociceptors are assessed using the Belmonte gas esthesiometer. All baseline measurements are repeated after one month of tear supplementation with zinc-hyaluronate (Ophylosa eye drop) 4x/day
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients receiving zinc-hyaluronate eye drop Receives: Device: Ophylosa tear supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in OSDI (Ocular Surface Disease Index) score
The change in OSDI (Ocular Surface Disease Index) score will be assessed using the specific OSDI questionnaire
Measured: 1 month
Secondary outcomes (1)
Change in corneal sensitivity to selective stimulation
Corneal sensitivity to selective (thermal, mechanical, chemical) stimulation will be assessed using the noncontact Belmonte gas esthesiometer. Mechanical, chemical (CO2 in air), and cold stimuli were used during three-second air pulses of adjustable flow rate, composition (CO2%) and temperature.The good reproducibility of mechanical, heat and chemical threshold measurements using noncontact esthesiometers has been previously reported in several studies.
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 posted1 Nov 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2016
- Study completionOct 2016
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.
- More trials run by Semmelweis UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kovács Illés, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951910
- Sponsor's protocol ID
- SemmelweisU
- Status last verified
- Oct 2016
- First submitted
- 28 Oct 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Perenyi K, Dienes L, Kornafeld A, Kovacs B, Kiss HJ, Szepessy Z, Nagy ZZ, Barsi A, Acosta MC, Gallar J, Kovacs I. The Effect of Tear Supplementation with 0.15% Preservative-Free Zinc-Hyaluronate on Ocular Surface Sensations in Patients with Dry Eye. J Ocul Pharmacol Ther. 2017 Jul/Aug;33(6):487-492. doi: 10.1089/jop.2016.0194. Epub 2017 Apr 4.
PubMed 28375789
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effect of Zinc-Hyaluronate on Ocular Surface Sensations in Patients With Dry Eye
- ClinicalTrials.gov ID
- NCT02951910
- Acronym / sponsor ID
- SemmelweisU
- Conditions
- Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 1 Nov 2016 (estimated)
- 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.
Hyaluronic acid, a natural polymer, helps to maintain ocular surface hydration and can already be found in several artificial tears recommended to alleviate symptoms of dry eye. A recent hyaluronate modification involves zinc-hyaluronate complex formation by adding zinc-chloride to an aqueous sodium-hyaluronate resulting in a very stable molecular structure, which functions as both a mechanical barrier and a biocompatible film on the ocular surface. Apart from its beneficial elastoviscous characteristics, previous results indicate that hyaluronate can also reduce the excitability of the peripheral nociceptor endings underlying pain. Although hyaluronate is widely used in artificial tears to improve tear film stability, its effect on ocular surface sensitivity was not evaluated in patients with dry eye. The aim of this study is to investigate the characteristics of ocular surface sensations and corneal sensitivity in dry eye patients before and after long-term tear supplementation with zinc-hyaluronate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Ophylosa tear supplementPatients receiving zinc-hyaluronate eye drop |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who had been diagnosed as having dry eye symptoms for at least 3 months, with an OSDI score of ≥13 evaluated by the questionnaire of Ocular Surface Disease Index (OSDI)
Key exclusion criteria (1 listed)
- Subjects with ophthalmic conditions other than dry eye or systemic disease including blepharitis, meibomitis, lid abnormalities as well as contact lens wearers
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 |
|---|---|---|
| Ophylosa tear supplementTear film dynamics is assessed by non-invasive tear film breakup time (NI-BUT) in parallel with continuous recordings of ocular sensations during forced blinking. Corneal sensitivity thresholds to selective stimulation of corneal mechanonociceptors, thermal receptors and chemical nociceptors are assessed using the Belmonte gas esthesiometer. All baseline measurements are repeated after one month of tear supplementation with zinc-hyaluronate (Ophylosa eye drop) 4x/day | Device | Intervention |
Primary outcome
Change in OSDI (Ocular Surface Disease Index) score
Time frame: 1 month
The change in OSDI (Ocular Surface Disease Index) score will be assessed using the specific OSDI questionnaire
1 secondary outcome
Change in corneal sensitivity to selective stimulation
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 1 Nov 2016.
- Derived from this study: PubMed 28375789Perenyi K, Dienes L, Kornafeld A, Kovacs B, Kiss HJ, Szepessy Z, Nagy ZZ, Barsi A, Acosta MC, Gallar J, Kovacs I. The Effect of Tear Supplementation with 0.15% Preservative-Free Zinc-Hyaluronate on Ocular Surface Sensations in Patients with Dry Eye. J Ocul Pharmacol Ther. 2017 Jul/Aug;33(6):487-492. doi: 10.1089/jop.2016.0194. Epub 2017 Apr 4.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ophylosa tear supplement in people with Dry Eye, run by Semmelweis University.
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 1 inclusion and 1 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 1 Nov 2016. 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.
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 OSDI (Ocular Surface Disease Index) score (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 NCT02951910, 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 1 Nov 2016.