A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week

Subjective ratings scale (0-100) assessed: 0=Cannot be worn, causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever. Time points for comfort: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.

Subjective ratings scale (0-100): 0=Cannot be worn, extremely dry, 20=Frequently Irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=No dryness experienced at any time. Time points for dryness: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.

Grading scale 0-4, 0.25 steps, 0=excellent; 4=severely reduced.

Grade ratings category (smooth, grainy, or other)

Grade ratings category (smooth, grainy, or other)

Logarithm of the Minimum Angle or Resolution (LogMAR) Chart

Lens Deposits Scale 0-4, 0.25 steps. 0=excellent; 4=severely reduced

Lenses were evaluated for defects, scratches, fibers, blue specks, and other findings.

Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.

(mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior

Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.

(mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior

Post-blink movement evaluated by estimating the distance the lens was moving immediately after a blink. Primary Gaze: (mm, 0.1 steps)

Lens tightness Scale 0%-100%, 0%=extremely loose fit, 50%=optimal push resistance and smooth return, 100%=no movement.

Subjective ratings scale (0-100): 0=Extremely poor vision all of the time; cannot function, 20=Frequently annoying vision problems, 40=Occasionally annoying vision problems, 60=Occasionally noticeable but not annoying vision problems, 80=Rarely noticeable vision problems, 100=Excellent vision all of the time. Different time points were taken for vision quality: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.

Subjective ratings scale (0-100): 0=Could not place lens on eye, 20=Frequently takes multiple attempts to place on eye; often unsuccessful, 40=Frequently takes multiple attempts to place on eye, 60=Occasionally takes a few attempts to place on eye, 80=Rarely difficult to place on eye, 100=Always easy to place lens on eye

Subjective ratings scale (0-100): 0=Could not remove lens from eye, 20=Frequently takes multiple attempts to remove from eye; often unsuccessful, 40=Frequently takes multiple attempts to remove from eye, 60=Occasionally takes a few attempts to remove from eye, 80=Rarely difficult to remove from eye, 100=Always easy to remove lens from eye.

Overall Lens Fit Scale 0-4, 0.25 steps 0=Very poor (lens should not be worn at all);

• Poor (lens could be worn with supervision only);
• Fair (would prefer to refit, but clinically acceptable);
• Good (fit could be slightly improved);
• Very good (optimal)

Bulbar hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.

Limbal hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.

Corneal Staining: Dehydration Staining: Yes/No

Corneal staining extent, grade as % of each zone:

C - Central, N - Nasal, T - Temporal, S - Superior, I - Interior

Conjunctival Indentation 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4, 0.5 steps; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe

Conjunctival Staining 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4; 0.5 steps, 0=None,1=Minimal diffuse punctuate, 2=Coalescent punctuate, 3=Confluent, 4=Deep confluent