Fluorescein Staining is measured with the Ora Calibra® Corneal and Conjunctival Staining Scale which is a 0 to 4 scale with increasing half-units and where higher numbers indicating more severe staining.

K-161 compared to Vehicle. When study patients are exposed to Controlled Adverse Environment (CAE) in terms of relative humidity, temperature, airflow, and visual tasking, the ocular surface is stressed to react. This controlled environmental stress creates a consistent response that's reproducible over time.

Endpoints analysis was determined by comparing 0.1% K-161 BID to its Vehicle BID

Ocular discomfort scores were subjectively graded by the subjects using the Ora Calibra® Ocular Discomfort Scale from 0 to 4 where 0 = No Discomfort and 4 = Constant Discomfort.

Endpoints analysis was determined by comparing 0.1% K-161 BID to its Vehicle BID

Measured with Schirmer's test strip with the length of the moistened area recorded in mm. Lower values indicate less tears produced in the eye.

Endpoints analysis was determined by comparing 0.1% K-161 BID to its Vehicle BID

Endpoints analysis was determined by comparing 0.1% K-161 BID to its Vehicle BID

Fluorescein Staining is measured with the Ora Calibra® Corneal and Conjunctival Staining Scale which is a 0 to 4 scale with increasing half-units and where higher numbers indicating more severe staining.

Endpoints analysis was determined by comparing Vehicle BID to 0.1% K-161 BID and 0.025% K-161 BID

Ora Calibra Scale which is 0 to 4 scale with increasing half-units and where higher numbers indicating more severe staining.

Endpoints analysis was determined by comparing Vehicle BID to 0.1% K-161 BID and 0.025% K-161 BID

Conjunctival Redness Scale ranges from 0 to 4, where 0 = normal, without vasodilation and 4 = Broad Ciliary and Prominent, Horizontal Conjunctival Vasodilation. Higher scores indicate worsening conjunctival redness.

Endpoints analysis was determined by comparing Vehicle BID to 0.1% K-161 BID and 0.025% K-161 BID

Endpoints analysis was determined by comparing Vehicle BID to 0.1% K-161 BID and 0.025% K-161 BID

Endpoints analysis was determined by comparing Vehicle BID to 0.1% K-161 BID and 0.025% K-161 BID

Measured with Schirmer's test strip with the length of the moistened area recorded in mm. Lower values indicate less tears produced in the eye.

Endpoints analysis was determined by comparing Vehicle BID to 0.1% K-161 BID and 0.025% K-161 BID

Blinks per 60 seconds.

Endpoints analysis was determined by comparing Vehicle BID to 0.1% K-161 BID and 0.025% K-161 BID

Ora Calibra® Ocular Discomfort Scale ranging from 0 to 4

Endpoints analysis was determined by comparing Vehicle BID to 0.1% K-161 BID and 0.025% K-161 BID

Scores ranging from 0 to 5. A score of 0 indicates no discomfort/symptoms and a score of 5 indicates worst discomfort/symptoms.

Endpoints analysis was determined by comparing Vehicle BID to 0.1% K-161 BID and 0.025% K-161 BID

The length of the assessment line was 100 mm; a measure of 0 mm corresponded to "no discomfort" and 100 mm corresponds to "maximal discomfort".

Endpoints analysis was determined by comparing Vehicle BID to 0.1% K-161 BID and 0.025% K-161 BID

The OSDI© is comprised of 12 questions, with each question assessed on a scale ranging from 0 to 4 where 0 = none of the time, 1 = some of the time, 2 = half of the time, 3 = most of the time, and 4 = all of the time. The range of total score is "0 to 100". "Subscale" scores are not reported. Higher score represents a worsen outcome. The total score is the sum of subscales.

Endpoints analysis was determined by comparing Vehicle BID to 0.1% K-161 BID and 0.025% K-161 BID