The SANDE uses a 100 mm visual analog scale (VAS) and asks the subject to score frequency and severity of their ocular discomfort over the past 24 hours by putting a vertical mark on two separate horizontal scoring lines. The frequency scoring line utilizes the anchors of 'Rarely' to 'All the Time', while the severity scoring line utilizes the anchors of 'Very Mildly' to 'Very Severely uncomfortable'. The SANDE questionnaire was completed through an electronic diary by the subject at the Screening Visit(s) of Part 1, and thereafter every evening before bedtime during the study. The overall SANDE score was calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranged from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms. Negative change from baseline indicates improvement.

Full Analysis Set 1 including subjects with a value at both Baseline and post-baseline visit. Baseline is defined as the last available value collected prior to or on the first administration of randomized study treatment.

The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Each of the five regions (central (C), superior (S), inferior (I), temporal (T), and nasal (N)) were graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining. After entry of the scores per region, the total or composite (sum) score for each eye was automatically calculated (maximum score = 20/eye). A (+1) was added to the sum score for any eye with the presence of filaments.

Full Analysis Set 1 including subjects with a value at both Baseline and post-baseline visit. Baseline is defined as the last available value collected prior to or on the first administration of randomized study treatment.

The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Central region was graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining.

Full Analysis Set 1 including subjects with a value at both Baseline and post-baseline visit. Baseline is defined as the last available value collected prior to or on the first administration of randomized study treatment.

The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Inferior region was graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining.

Full Analysis Set 1 including subjects with a value at both Baseline and post-baseline visit. Baseline is defined as the last available value collected prior to or on the first administration of randomized study treatment.

The number of treatment emergent ocular and non-ocular adverse events was reported categorically: Mild, Moderate, Severe.

Treatment emergent adverse events (TEAEs) are adverse events started after the first administration of randomized study treatment or events present prior to start of the randomized treatment but increased in severity based on preferred term.

Safety Set 1