Table 2.
Demographics and baseline characteristics
| n | Modified intent-to-treat (mITT) populationa (N = 35) | |
|---|---|---|
| Age, years, mean (SD) | 35 | 63.3 (10.2) |
| Sex, no. (%) | 35 | |
| Male | 10 (28.6) | |
| Female | 25 (71.4) | |
| Race, no. (%) | 35 | |
| White | 28 (80.0) | |
| Black or African American | 7 (20.0) | |
| Ethnicity, no. (%) | 35 | |
| Hispanic or Latino | 2 (5.7) | |
| Not Hispanic or Latino | 33 (94.3) | |
| Impact of Dry Eye on Everyday Life (IDEEL) Questionnaire, mean (SD) [scale 0–100] | ||
| Impact on daily activities | 34 | 64.5 (20.1) |
| Emotional impact | 34 | 65.6 (21.8) |
| Impact on work | 17 | 60.3 (19.4) |
| Satisfaction with treatment effectiveness | 16 | 22.7 (21.0) |
| Treatment-related bother | 21 | 59.1 (32.6) |
| Symptom bother | 34 | 65.4 (15.5) |
| Ocular Discomfort and 4-Symptom Questionnaire, mean (SD) [scale 0–5] | ||
| Ocular discomfort score (ODS) | 35 | 3.2 (0.9) |
| Burning | 35 | 1.7 (1.3) |
| Dryness | 35 | 3.5 (1.0) |
| Grittiness | 35 | 2.5 (1.3) |
| Stinging | 35 | 2.1 (1.4) |
| Visual Analog Scale (VAS), mean (SD) [scale 0–100] | ||
| Eye dryness | 29 | 77.6 (18.2) |
| Burning/stinging | 29 | 45.3 (29.1) |
| Itching | 29 | 44.1 (29.5) |
| Foreign body sensation | 29 | 50.9 (27.8) |
| Eye discomfort | 29 | 71.3 (20.3) |
| Photophobia | 29 | 57.0 (25.7) |
| Pain | 29 | 34.5 (23.3) |
| Corneal Staining Scale, mean (SD) | ||
| Inferior [scale 0–4] | 35 | 2.2 (0.3) |
| Superior [scale 0–4] | 35 | 1.8 (0.6) |
| Central [scale 0–4] | 35 | 1.4 (0.5) |
| Corneal sum for fluorescein | 35 | 5.3 (0.9) |
| Conjunctival Staining Scale, mean (SD) | ||
| Temporal [scale 0–4] | 35 | 1.8 (0.7) |
| Nasal [scale 0–4] | 35 | 1.9 (0.7) |
| Conjunctival sum for lissamine green | 35 | 3.5 (1.3) |
| Conjunctival Redness Scale, mean (SD) [scale 0–4] | 35 | 1.6 (0.6) |
| Schirmer’s test, mm, mean (SD) | 35 | 3.2 (1.8) |
| Visual acuity, Logarithm of the Minimum Angle of Resolution (logMAR), mean (SD) | 35 | 0.1 (0.1) |
| Intraocular pressure, mm Hg | 35 | 15.9 (3.0) |
aAll patients who received at least one dose of RCI and who contributed any post-baseline efficacy data to the study