Dry Eye SyndromesPhase 2NCT06188260
Efficacy of a New Nanoemulsion Artificial Tear Targeting Dry Eye Disease
A Phase 2 study testing Systane COMPLETE Lubricant Eye Drops in people with Dry Eye Syndromes, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This is a prospective cohort study to compare subjective changes in symptoms using the Ocular Surface Disease Index (OSDI) questionnaire, following the recommended dosage of the new nanoemulsion eye drops (Systane Complete)in mild to moderate dry eye patients, and to investigate objective ocular surface changes using… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Systane COMPLETE Lubricant Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteHong Kong
- Study dates
- 16 Jan 2024to 4 Nov 2024
- Phase
- Phase 2
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20-50 years old
- Best corrected distance visual acuity ≥ 6/9
- Mild to moderate OSDI score 13-32
- Any one of the objective test positive (NITBUT/Corneal fluorescein staining/Tear osmolarity)
Who cannot join
- Any active ocular infections
- Inflammations or anomalies in the eyelid
- Uncontrolled, newly diagnosed systemic diseases or with modified long-term medications within 6 months that are known to affect tear profile.
- Pregnancy and breastfeeding
- Contact lens wearers are required to stop contact lenses wear for at least 1 week before the evaluation.
- Subjects who are using artificial tears or other eyedrops will be excluded.
- Subjects who are taking systemic drugs that may cause dry eye, e.g., Antidepressants/antipsychotics, Systemic corticosteroids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a New Nanoemulsion Artificial Tear in Dry Eye Disease Management
This is a prospective cohort study to compare subjective changes in symptoms using the Ocular Surface Disease Index (OSDI) questionnaire, following the recommended dosage of the new nanoemulsion eye drops (Systane Complete)in mild to moderate dry eye patients, and to investigate objective ocular surface changes using modern clinical instruments during the study period.
Read the detailed description
This study, lasting for 3 months in total, is to investigate the changes in both subjective reports (OSDI score) and objective measurements (Non-invasive Tear Break Time (NITBUT) and other clinical signs such as corneal staining) after the use of this nanoemulsion eye drops (Systane Complete). Subjects are required to use the eyedrop qid for 3 months, and come back for follow-up at 2-week and 3-month visits. Other secondary measurements such as Meibography and lipid layer thickness, will also be investigated.
- Conditions
- Dry Eye Syndromes
- Being tested
- Systane COMPLETE Lubricant Eye Drops
- 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.
Systane COMPLETE Lubricant Eye DropsDrug
Also called Alcon limited
Active Ingredients: Propylene Glycol 0.6% Purpose: Lubricant
| Study group | Role | What they receive |
|---|---|---|
| Dry eye participants | Experimental | Participants aged 20 years or above, with OSDI score between 12-32, and with either of the following positive signs: 1) corneal staining; 2) NITBUT<10s; 3) osmolarity >=308, or difference >8 Receives: Drug: Systane COMPLETE Lubricant Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index (OSDI)
Change in OSDI score at 2-week visit
Measured: Change in OSDI score at 2-week visit
Secondary outcomes (2)
Non invasive tear break-up time (NITBUT)
NITBUT at 2-week and 3-month visits
Measured: NITBUT at 2-week and 3-month visits
Meibography
Meibography at 2-week and 3-month visits
Measured: Meibography at 2-week and 3-month visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start16 Jan 2024
- Primary completion4 Nov 2024
- Study completion4 Nov 2024
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 Eye SyndromesStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, LAM Chuen Thomas, FAAO, PhD, The Hong Kong Polytechnic University
- Investigators
- Thomas LAM, PhD, Principal investigator, The Hong Kong Polytechnique University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188260
- Sponsor's protocol ID
- 20230209004
- Status last verified
- Dec 2023
- First submitted
- 18 Dec 2023
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liao X, Guo B, Bian J, Li PH, Tse JSH, Ngo W, Zhou L, Lam T. Efficacy of a new nanoemulsion artificial tear in dry eye disease management: Study protocol for a prospective cohort study. PLoS One. 2025 May 9;20(5):e0323523. doi: 10.1371/journal.pone.0323523. eCollection 2025.
PubMed 40343954
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a New Nanoemulsion Artificial Tear in Dry Eye Disease Management
- ClinicalTrials.gov ID
- NCT06188260
- Acronym / sponsor ID
- 20230209004
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 3 Jan 2024 (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.
This is a prospective cohort study to compare subjective changes in symptoms using the Ocular Surface Disease Index (OSDI) questionnaire, following the recommended dosage of the new nanoemulsion eye drops (Systane Complete)in mild to moderate dry eye patients, and to investigate objective ocular surface changes using modern clinical instruments during the study period.
Detailed description
This study, lasting for 3 months in total, is to investigate the changes in both subjective reports (OSDI score) and objective measurements (Non-invasive Tear Break Time (NITBUT) and other clinical signs such as corneal staining) after the use of this nanoemulsion eye drops (Systane Complete). Subjects are required to use the eyedrop qid for 3 months, and come back for follow-up at 2-week and 3-month visits. Other secondary measurements such as Meibography and lipid layer thickness, will also be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dry eye participants | Experimental | Drug: Systane COMPLETE Lubricant Eye DropsParticipants aged 20 years or above, with OSDI score between 12-32, and with either of the following positive signs: 1) corneal staining; 2) NITBUT<10s; 3) osmolarity >=308, or difference >8 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 20-50 years old
- Best corrected distance visual acuity ≥ 6/9
- Mild to moderate OSDI score 13-32
- Any one of the objective test positive (NITBUT/Corneal fluorescein staining/Tear osmolarity)
Key exclusion criteria (7 listed)
- Any active ocular infections
- Inflammations or anomalies in the eyelid
- Uncontrolled, newly diagnosed systemic diseases or with modified long-term medications within 6 months that are known to affect tear profile.
- Pregnancy and breastfeeding
- Contact lens wearers are required to stop contact lenses wear for at least 1 week before the evaluation.
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 |
|---|---|---|
| Systane COMPLETE Lubricant Eye DropsAlso: Alcon limitedActive Ingredients: Propylene Glycol 0.6% Purpose: Lubricant | Drug | Dry eye participants |
Primary outcome
Ocular Surface Disease Index (OSDI)
Time frame: Change in OSDI score at 2-week visit
Change in OSDI score at 2-week visit
2 secondary outcomes
Non invasive tear break-up time (NITBUT)
Time frame: NITBUT at 2-week and 3-month visits
Meibography
Time frame: Meibography at 2-week and 3-month visits
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 2 Dec 2024.
- Derived from this study: PubMed 40343954Liao X, Guo B, Bian J, Li PH, Tse JSH, Ngo W, Zhou L, Lam T. Efficacy of a new nanoemulsion artificial tear in dry eye disease management: Study protocol for a prospective cohort study. PLoS One. 2025 May 9;20(5):e0323523. doi: 10.1371/journal.pone.0323523. eCollection 2025.
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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.
Thomas LAM, PhD principal investigator
The Hong Kong Polytechnique University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Systane COMPLETE Lubricant Eye Drops in people with Dry Eye Syndromes, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 7 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 2 Dec 2024. 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 Hong Kong. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Ocular Surface Disease Index (OSDI) (time frame: Change in OSDI score at 2-week visit). 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 NCT06188260, 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 2 Dec 2024.