Dry Eye Syndromes
Conditions
Brief 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 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.
Interventions
DRUGSystane COMPLETE Lubricant Eye Drops
Active Ingredients: Propylene Glycol 0.6% Purpose: Lubricant
Sponsors
Alcon Research
The Hong Kong Polytechnic University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Age 20-50 years old 2. Best corrected distance visual acuity ≥ 6/9 3. Mild to moderate OSDI score 13-32 4. Any one of the objective test positive (NITBUT/Corneal fluorescein staining/Tear osmolarity)
Exclusion criteria
1. Any active ocular infections 2. Inflammations or anomalies in the eyelid 3. Uncontrolled, newly diagnosed systemic diseases or with modified long-term medications within 6 months that are known to affect tear profile. 4. Pregnancy and breastfeeding 5. Contact lens wearers are required to stop contact lenses wear for at least 1 week before the evaluation. 6. Subjects who are using artificial tears or other eyedrops will be excluded. 7. Subjects who are taking systemic drugs that may cause dry eye, e.g., Antidepressants/antipsychotics, Systemic corticosteroids.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Disease Index (OSDI) | Change in OSDI score at 2-week visit | Change in OSDI score at 2-week visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Meibography at 2-week and 3-month visits |
Countries
Hong Kong
Outcome results
None listed