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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systane COMPLETE Lubricant Eye Drops | Drug | Active Ingredients: Propylene Glycol 0.6% Purpose: Lubricant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Disease Index (OSDI) | Change in OSDI score at 2-week visit | Change in OSDI score at 2-week visit |
| Measure | Description | Time Frame |
|---|---|---|
| Non invasive tear break-up time (NITBUT) | NITBUT at 2-week and 3-month visits | NITBUT at 2-week and 3-month visits |
| Meibography | Meibography at 2-week and 3-month visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas LAM, PhD | The Hong Kong Polytechnique University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas LAM | Hong Kong | Hong Kong | 999077 | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40343954 | Derived | 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. |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Meibography at 2-week and 3-month visits |