Trial Outcomes & Findings for A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week (NCT NCT02500368)

NCT ID: NCT02500368

Last Updated: 2020-07-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 41 participants
• Primary outcome timeframe: Baseline and 1 week
• Results posted on: 2020-07-29

Participant Flow

One participant discontinued from the study as a screen failure before lens randomization.

Participant milestones

Measure	Silicone Hydrogel Lens (Test), Then Enfilcon A Lens (Control) Participants were randomized to wear silicone hydrogel lens (test) for 1 week, then cross over to the enfilcon A lens (control). silicone hydrogel lens (test): contact lens enfilcon A lens (control): contact lens	Enfilcon A Lens (Control), Then Silicone Hydrogel Lens (Test) Participants were randomized to wear enfilcon A lens (control) for 1 week, then cross over to the silicone hydrogel lens (test). enfilcon A lens (control): contact lens silicone hydrogel lens (test): contact lens
First Intervention (1 Week) STARTED	20	20
First Intervention (1 Week) COMPLETED	20	20
First Intervention (1 Week) NOT COMPLETED	0	0
Second Intervention (1 Week) STARTED	20	20
Second Intervention (1 Week) COMPLETED	20	20
Second Intervention (1 Week) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Overall Baseline Characteristics n=41 Participants Participants were randomized to wear silicone hydrogel lens (test) or enfilcon A lens (control) for 1 week during the cross over study.
Age, Continuous	24 years n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 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.

Outcome measures

Measure	Silicone Hydrogel Lens (Test) n=40 Participants Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Enfilcon A Lens (Control) n=40 Participants Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Comfort Lens dispense at baseline	90 units on a scale Standard Deviation 11	91 units on a scale Standard Deviation 10
Comfort Lens insertion at 1 week	92 units on a scale Standard Deviation 9	90 units on a scale Standard Deviation 14
Comfort Overall comfort at 1 week	79 units on a scale Standard Deviation 15	81 units on a scale Standard Deviation 13

PRIMARY outcome

Timeframe: Baseline and 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.

Outcome measures

Measure	Silicone Hydrogel Lens (Test) n=40 Participants Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Enfilcon A Lens (Control) n=40 Participants Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Dryness Lens dispense at baseline	94 units on a scale Standard Deviation 10	94 units on a scale Standard Deviation 10
Dryness Lens insertion at 1 week	94 units on a scale Standard Deviation 8	92 units on a scale Standard Deviation 12
Dryness Overall dryness at 1 week	75 units on a scale Standard Deviation 19	78 units on a scale Standard Deviation 16

SECONDARY outcome

Timeframe: Baseline and 1 week

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

Outcome measures

Measure	Silicone Hydrogel Lens (Test) n=40 Participants Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Enfilcon A Lens (Control) n=40 Participants Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Lens Wettability Baseline	1.09 units on a scale Standard Deviation 0.60	1.18 units on a scale Standard Deviation 0.87
Lens Wettability 1 week	1.17 units on a scale Standard Deviation 0.76	1.38 units on a scale Standard Deviation 0.79

SECONDARY outcome

Timeframe: Baseline

Grade ratings category (smooth, grainy, or other)

Outcome measures

Measure	Silicone Hydrogel Lens (Test) n=80 Eyes Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Enfilcon A Lens (Control) n=80 Eyes Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Surface Appearance Smooth	76 Eyes	70 Eyes
Surface Appearance Grainy	3 Eyes	4 Eyes
Surface Appearance Other	1 Eyes	6 Eyes

SECONDARY outcome

Timeframe: 1 week

Grade ratings category (smooth, grainy, or other)

Outcome measures

Measure	Silicone Hydrogel Lens (Test) n=80 Eyes Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Enfilcon A Lens (Control) n=80 Eyes Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Surface Appearance Smooth	77 Eyes	72 Eyes
Surface Appearance Grainy	1 Eyes	4 Eyes
Surface Appearance Other	2 Eyes	4 Eyes

SECONDARY outcome

Timeframe: Baseline and 1 week

Logarithm of the Minimum Angle or Resolution (LogMAR) Chart

Outcome measures

Measure	Silicone Hydrogel Lens (Test) n=40 Participants Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Enfilcon A Lens (Control) n=40 Participants Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
High Contrast Acuity at High Room Illumination Baseline	-0.10 LogMAR Standard Deviation 0.06	-0.09 LogMAR Standard Deviation 0.04
High Contrast Acuity at High Room Illumination 1 week	-0.10 LogMAR Standard Deviation 0.05	-0.08 LogMAR Standard Deviation 0.06

SECONDARY outcome

Timeframe: Baseline and 1 week

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

Outcome measures

Measure	Silicone Hydrogel Lens (Test) n=40 Participants Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Enfilcon A Lens (Control) n=40 Participants Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Lens Deposition Baseline	0.06 units on a scale Standard Deviation 0.13	0.12 units on a scale Standard Deviation 0.21
Lens Deposition 1 week	0.28 units on a scale Standard Deviation 0.32	0.38 units on a scale Standard Deviation 0.48

SECONDARY outcome

Timeframe: Baseline and 1 week

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

Outcome measures

Measure	Silicone Hydrogel Lens (Test) n=80 Lenses Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Enfilcon A Lens (Control) n=80 Lenses Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Lens Problems Baseline, Blue specs	0 Lenses	2 Lenses
Lens Problems Baseline, Fibers	0 Lenses	1 Lenses
Lens Problems Baseline, Nick	0 Lenses	1 Lenses
Lens Problems 1 week, Blue specs	0 Lenses	2 Lenses
Lens Problems 1 week, Nick	0 Lenses	1 Lenses
Lens Problems 1 week, Particles	0 Lenses	3 Lenses

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Silicone Hydrogel Lens (Test) n=80 Eyes Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Enfilcon A Lens (Control) n=80 Eyes Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Lens Centration No decentration	46 eyes	32 eyes
Lens Centration N	4 eyes	3 eyes
Lens Centration T	16 eyes	16 eyes
Lens Centration S	6 eyes	6 eyes
Lens Centration I	4 eyes	11 eyes
Lens Centration N/S	0 eyes	0 eyes
Lens Centration N/I	0 eyes	2 eyes
Lens Centration T/S	2 eyes	6 eyes
Lens Centration T/I	2 eyes	4 eyes

SECONDARY outcome

Timeframe: 1 week

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

Outcome measures

Measure	Silicone Hydrogel Lens (Test) n=80 Eyes Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Enfilcon A Lens (Control) n=80 Eyes Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Lens Centration T/S	3 eyes	2 eyes
Lens Centration No decentration	43 eyes	51 eyes
Lens Centration N	1 eyes	1 eyes
Lens Centration T	12 eyes	6 eyes
Lens Centration S	8 eyes	4 eyes
Lens Centration I	10 eyes	9 eyes
Lens Centration N/S	1 eyes	0 eyes
Lens Centration N/I	1 eyes	0 eyes
Lens Centration T/I	1 eyes	7 eyes

SECONDARY outcome

Timeframe: Baseline and 1 week

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

Outcome measures

Measure	Silicone Hydrogel Lens (Test) n=40 Participants Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Enfilcon A Lens (Control) n=40 Participants Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Post-blink Movement Baseline	0.26 mm steps Standard Deviation 0.16	0.25 mm steps Standard Deviation 0.10
Post-blink Movement 1 week	0.24 mm steps Standard Deviation 0.10	0.27 mm steps Standard Deviation 0.13

SECONDARY outcome

Timeframe: Baseline and 1 week

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

Outcome measures

Measure	Silicone Hydrogel Lens (Test) n=40 Participants Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Enfilcon A Lens (Control) n=40 Participants Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Lens Tightness Baseline	50.9 percentage of tightness Standard Deviation 7.8	48.1 percentage of tightness Standard Deviation 6.3
Lens Tightness 1 week	48.8 percentage of tightness Standard Deviation 9.1	47.9 percentage of tightness Standard Deviation 6.4

SECONDARY outcome

Timeframe: Baseline and 1 week

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.

Outcome measures

Measure	Silicone Hydrogel Lens (Test) n=40 Participants Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Enfilcon A Lens (Control) n=40 Participants Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Visual Quality Lens dispense at baseline	94 units on a scale Standard Deviation 7	93 units on a scale Standard Deviation 9
Visual Quality Lens insertion at 1 week	95 units on a scale Standard Deviation 7	94 units on a scale Standard Deviation 9
Visual Quality Overall vision quality at 1 week	88 units on a scale Standard Deviation 12	88 units on a scale Standard Deviation 13

SECONDARY outcome

Timeframe: Baseline and 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

Outcome measures

Measure	Silicone Hydrogel Lens (Test) n=40 Participants Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Enfilcon A Lens (Control) n=40 Participants Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Ease of Lens Insertion Baseline	97 units on a scale Standard Deviation 5	92 units on a scale Standard Deviation 10
Ease of Lens Insertion 1 week	91 units on a scale Standard Deviation 9	90 units on a scale Standard Deviation 10

SECONDARY outcome

Timeframe: 1 week

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.

Outcome measures

Measure	Silicone Hydrogel Lens (Test) n=40 Participants Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Enfilcon A Lens (Control) n=40 Participants Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Ease of Lens Removal	86 units on a scale Standard Deviation 15	90 units on a scale Standard Deviation 12

SECONDARY outcome

Timeframe: Baseline and 1 week

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

1. Poor (lens could be worn with supervision only);

2. Fair (would prefer to refit, but clinically acceptable);

3. Good (fit could be slightly improved);

4. Very good (optimal)

Outcome measures

Measure	Silicone Hydrogel Lens (Test) n=40 Participants Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Enfilcon A Lens (Control) n=40 Participants Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Overall Lens Fit Baseline	3.35 units on a scale Standard Deviation 0.42	3.33 units on a scale Standard Deviation 0.36
Overall Lens Fit 1 week	3.36 units on a scale Standard Deviation 0.41	3.38 units on a scale Standard Deviation 0.48

SECONDARY outcome

Timeframe: Baseline and 1 week

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

Outcome measures

Measure	Silicone Hydrogel Lens (Test) n=40 Participants Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Enfilcon A Lens (Control) n=40 Participants Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Bulbar Hyperemia Baseline	1.96 units on a scale Standard Deviation 0.50	1.96 units on a scale Standard Deviation 0.50
Bulbar Hyperemia 1 week	1.87 units on a scale Standard Deviation 0.44	1.95 units on a scale Standard Deviation 0.41

SECONDARY outcome

Timeframe: Baseline and 1 week

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

Outcome measures

Measure	Silicone Hydrogel Lens (Test) n=40 Participants Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Enfilcon A Lens (Control) n=40 Participants Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Limbal Hyperemia Baseline	1.76 units on a scale Standard Deviation 0.51	1.76 units on a scale Standard Deviation 0.51
Limbal Hyperemia 1 week	1.68 units on a scale Standard Deviation 0.42	1.71 units on a scale Standard Deviation 0.37

SECONDARY outcome

Timeframe: 1 week

Corneal Staining: Dehydration Staining: Yes/No

Outcome measures

Measure	Silicone Hydrogel Lens (Test) n=40 Participants Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Enfilcon A Lens (Control) n=40 Participants Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Corneal Dehydration Staining Both eyes	3 participants	1 participants
Corneal Dehydration Staining One eye	2 participants	2 participants

SECONDARY outcome

Timeframe: Baseline and 1 week

Corneal staining extent, grade as % of each zone:

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

Outcome measures

Measure	Silicone Hydrogel Lens (Test) n=40 Participants Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Enfilcon A Lens (Control) n=40 Participants Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Corneal Staining (Extent) Central - baseline	1.21 percentage of cornea Standard Deviation 4.97	1.21 percentage of cornea Standard Deviation 4.97
Corneal Staining (Extent) Central - 1 week	0.64 percentage of cornea Standard Deviation 1.73	0.75 percentage of cornea Standard Deviation 4.97
Corneal Staining (Extent) Nasal - baseline	4.76 percentage of cornea Standard Deviation 9.10	4.76 percentage of cornea Standard Deviation 9.10
Corneal Staining (Extent) Nasal - 1 week	2.20 percentage of cornea Standard Deviation 6.68	1.43 percentage of cornea Standard Deviation 4.79
Corneal Staining (Extent) Temporal - baseline	2.04 percentage of cornea Standard Deviation 5.47	2.04 percentage of cornea Standard Deviation 5.47
Corneal Staining (Extent) Temporal - 1 week	1.38 percentage of cornea Standard Deviation 4.05	1.04 percentage of cornea Standard Deviation 2.92
Corneal Staining (Extent) Superior - baseline	2.15 percentage of cornea Standard Deviation 7.21	2.15 percentage of cornea Standard Deviation 7.21
Corneal Staining (Extent) Superior - 1 week	1.75 percentage of cornea Standard Deviation 4.42	0.69 percentage of cornea Standard Deviation 2.07
Corneal Staining (Extent) Inferior - baseline	5.88 percentage of cornea Standard Deviation 10.85	5.88 percentage of cornea Standard Deviation 10.85
Corneal Staining (Extent) Inferior - 1 week	6.48 percentage of cornea Standard Deviation 11.52	5.01 percentage of cornea Standard Deviation 9.23

SECONDARY outcome

Timeframe: Baseline and 1 week.

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

Outcome measures

Measure	Silicone Hydrogel Lens (Test) n=40 Participants Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Enfilcon A Lens (Control) n=40 Participants Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Conjunctival Indentation Nasal - baseline	0.01 units on a scale Standard Deviation 0.11	0.01 units on a scale Standard Deviation 0.11
Conjunctival Indentation Nasal - 1 week	0.36 units on a scale Standard Deviation 0.64	0.01 units on a scale Standard Deviation 0.06
Conjunctival Indentation Temporal - baseline	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00
Conjunctival Indentation Temporal - 1 week	0.39 units on a scale Standard Deviation 0.68	0.02 units on a scale Standard Deviation 0.10
Conjunctival Indentation Superior - baseline	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00
Conjunctival Indentation Superior - 1 week	0.21 units on a scale Standard Deviation 0.49	0.02 units on a scale Standard Deviation 0.10
Conjunctival Indentation Inferior - baseline	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00
Conjunctival Indentation Inferior - 1 week	0.34 units on a scale Standard Deviation 0.67	0.03 units on a scale Standard Deviation 0.15

SECONDARY outcome

Timeframe: Baseline and 1 week

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

Outcome measures

Measure	Silicone Hydrogel Lens (Test) n=40 Participants Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Enfilcon A Lens (Control) n=40 Participants Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Conjunctival Staining Nasal - baseline	0.48 units on a scale Standard Deviation 0.45	0.48 units on a scale Standard Deviation 0.45
Conjunctival Staining Nasal - 1 week	0.67 units on a scale Standard Deviation 0.58	0.46 units on a scale Standard Deviation 0.40
Conjunctival Staining Temporal - baseline	0.47 units on a scale Standard Deviation 0.49	0.47 units on a scale Standard Deviation 0.49
Conjunctival Staining Temporal - 1 week	0.72 units on a scale Standard Deviation 0.63	0.55 units on a scale Standard Deviation 0.43
Conjunctival Staining Superior - baseline	0.12 units on a scale Standard Deviation 0.29	0.12 units on a scale Standard Deviation 0.29
Conjunctival Staining Superior - 1 week	0.25 units on a scale Standard Deviation 0.38	0.14 units on a scale Standard Deviation 0.26
Conjunctival Staining Inferior - baseline	0.23 units on a scale Standard Deviation 0.38	0.23 units on a scale Standard Deviation 0.38
Conjunctival Staining Inferior - 1 week	0.49 units on a scale Standard Deviation 0.52	0.32 units on a scale Standard Deviation 0.37

Adverse Events

Silicone Hydrogel Lens (Test)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enfilcon A Lens (Control)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sr. Manager Clinical Research

CooperVision Inc.

Phone: (925) 730-6754

Email: PChamberlain@coopervision.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER