Table 1.

The observation items and details of each item

Observation item	Timing of observation		Observation of cornea			Endothelium
	2 weeks before study entry	After 7-days of instillation	Epithelium	Stroma	Evaluation
Informed consent	○
Subject background	○
Concomitant drugs	○	○
Visual acuity test	○	○
Treatment compliance		○
Slit-lamp microscopy	○	○	✓			Observation of the corneal epithelium
Anterior-segment pictures (fluorescein staining) (BUT)	○	○	✓			Evaluation of the influence on the corneal epithelium
Specular microscope	○	○			✓	Observation of the corneal endothelium. Measurement of endothelial cell density, and coefficient of variation (CV)
DR-1 (BUT)	○	○	✓			Evaluation of influence on the corneal epithelium based on tear film Iipid layer grading
Schirmer l test (BUT)	○	○	✓			Lacrimation function based on tear volume
Pentacarn (Corneal thickness)	○	○		✓		Measurement of corneal thickness (influence on the corneal endothelium)
HRT II-RCM	○	○		✓		Morphological observation of the corneal stroma Evaluation of cell density
Adverse events	○	○
Questionnaire to assess satisfaction with use		○				Assessment of irritating sensation and drop comfort upon instillation using a VAS