single arm clinical study.

5 μL of the appropriate test should be instilled into the lower conjunctival sac of one eye, and another eye should be instilled with Normal Saline as Negative control. No Positive control to be taken.

Assessment would be done as 5-point scale for the below attributes after 1 min/2 min/5 min.

1.

Subjective discomfort,

Score 0: No discomfort felt Score 1: Faint, barely perceptible discomfort Score 2: Mild, low intensity discomfort that does not prevent the subject from opening lids Score 3: Moderately intense discomfort that interferes with but does not prevent lid opening Score 4: Severe, very intense discomfort that makes voluntary lid opening difficult, requires force to pull lids apart, and results in the subject requesting washout of test article

2.

Objective lacrimation,

Score 0: No tearing or lid wetness above normal Score 1: Noticeable increase in moistness of lid edges - no frank tearing Score 2: Frank tearing - meager flow Score 3: Frank tearing - moderate flow Score 4: Frank tearing - copious flow

3. Objective conjunctival inflammation,

Score 0: Inflammatory changes absent Score 1: Capillaries slightly more prominent than they were at time of baseline examination Score 2: Capillaries very prominent plus some diffuse conjunctival reddening Score 3: Vessels very prominent plus diffuse and confluent intense redness Score 4: Beefy redness and everted lids

4. Objective cornea and iris inflammation

Score 0: No effect detected with use of slit lamp Score 1: Barely perceptible clouding or pitting of cornea or thickening of iris detected via slit lamp Score 2: Faint clouding or pitting of cornea and/or thickening of the iris Score 3: Moderate clouding or pitting of cornea and/or thickening of the iris Score 4: Intense clouding orpitting of cornea and/or thickening of the iris

A follow-up visit is done after 24 hours to assess any adverse effect after the Product application