Table 2.
Secondary Endpoints Assessed in the Study
| Secondary endpoint | Method/scale | Scoring |
|---|---|---|
| Signs | ||
| Corneal damage | Fluorescein staininga | 5-point scale (0.5 U increments) grade 0 = none, 4 = severe |
| Lissamine Green staininga | 5-point scale (0.5 U increments) grade 0 = none, 4 = severe | |
| Conjunctival redness | Ora Calibra Conjunctival Redness Scale21 | 5-point scale (0.5-U increments); 0 = none, 4 = severe |
| Tear production | Schirmer's test (unanesthetized) | — |
| Tear film breakup | — | For each eye, 2 measurements were recorded and averaged unless the 2 measurements were >2 s apart and were each <10 s, in which case, a 3rd measurement was taken and the 2 closest of the 3 were averaged and used for analyses. Analyses were for the study eye only |
| Symptoms | ||
| Ocular discomfort | Ora Calibra Ocular Discomfort Scale19,20 | 5-point scale; 0 = no discomfort, 1 = intermittent awareness, 2 = constant awareness, 3 = intermittent discomfort, 4 = constant discomfort |
| Ora Calibra Ocular Discomfort and 4-Symptom Questionnaire19,20 | 6-point scale; 0 = no pain, 5 = the worst pain. 5 symptoms are graded separately: overall discomfort, burning, dryness, grittiness, and stinging | |
| Ocular Surface Disease Index22 | Scale of 0–100, with higher scores representing greater disability | |
| Visual analog scale: Symptoms assessed were burning/stinging, itching, foreign body sensation, eye discomfort, blurred vision, eye dryness, photophobia, and pain | Scored by asking patients to rate each ocular symptom due to ocular dryness by placing a mark on a 100-mm horizontal line to indicate the level of discomfort; 0 = no discomfort, 100 = maximal discomfort | |
| Ora Calibra Drop Comfort Scale and Questionnaire21,b | 11-point scale (0–10); 0 = very comfortable, 10 = very uncomfortable. Assessed immediately and at 1 and 2 min after dosing | |
a
By region (central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total staining). Corneal sum was the sum of the central, superior, and inferior regions (range 0–12). Conjunctival sum was the sum of the temporal and nasal regions (range 0–6). Total eye score was the sum of all 5 regions (range 0–20). Analyses were for the study eye only.
b
Assessed at baseline only.