Table 2.
Time point | Study period | |||
---|---|---|---|---|
Enrollment | Allocation | Post-allocation | ||
-t1 | t1 | t2 | t3 | |
(Week 0) | (Week 12) | (Week 24) | ||
Enrollment | ||||
Eligibility screen | × | |||
Informed consent | × | |||
Allocation | × | |||
Interventions | ||||
Tablet 1 and placebo 1 | ||||
Tablet 2 and placebo 1 | ||||
Tablet 3 and placebo 1 | ||||
Tablet 4 and placebo 1 | ||||
Tablet 4 and capsule 1 | ||||
Placebo 1 and placebo 2 | ||||
Assessments | ||||
Demographics | × | |||
Lifestyle behaviors | × | × | × | |
Medical history and medications | × | × | × | |
Dietary assessment | × | × | × | |
Anthropometry | × | × | × | |
MPOD | × | × | × | |
UCVA and BCVA | × | × | × | |
CS and GS | × | × | × | |
CFF | × | × | × | |
Reaction time | × | × | × | |
Visuognosis persistence | × | × | × | |
Symptoms and signs of DED | × | × | ||
Retinal thickness | × | × | ||
Optical quality | × | × | ||
DNA extraction and genotyping | × | |||
Fasting blood (e.g., serum lutein and zeaxanthin, RBC membrane omega-3 fatty acids) | × | × | × | |
Stool samples for microbiome analysis | × | × | ||
Provided supply of supplements | × | × | ||
Adverse events | × | × | × | |
Collect unused test product | × | × |
t1, baseline; t2, at 12 weeks; t3, at 24 weeks; MPOD, macular pigment optical density; UCVA, uncorrected visual acuity; BCVA, best-corrected visual acuity; CS, contrast sensitivity; GS, glare sensitivity; CFF, critical flicker fusion; DED, dry eye disease; RBC, red blood cell.