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

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02500368
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 20.1

Study Details

Study Description

Brief Summary

This is a 1-week dispensing, double-masked, randomized, bilateral study comparing the test lens against the control lens.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: silicone hydrogel lens (test); Device: enfilcon A lens (control)	N/A

Detailed Description

The order of lens wear (test lens first, control lens second or control lens first, test lens second) will be selected according to a randomization table.

Both test and control lenses will be used in a daily wear modality for 1 week. It is anticipated that this study will involve following visits: Baseline (screening and dispense of 1st study pair of lenses, visit combined), 1-week visit (follow-up of the 1st study pair of lenses and dispense the 2nd study pair of lenses) and 2-week visit (1 week follow-up of the 2nd study pair of lenses).

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: silicone hydrogel lens (test) Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.	Device: silicone hydrogel lens (test); contact lens
Active Comparator: enfilcon A lens (control) Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.	Device: enfilcon A lens (control); contact lens

Outcome Measures

Primary Outcome Measures

1. Comfort [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.

2. Dryness [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.

Secondary Outcome Measures

1. Lens Wettability [Baseline and 1 week]

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

2. Surface Appearance [Baseline]

   Grade ratings category (smooth, grainy, or other)

3. Surface Appearance [1 week]

   Grade ratings category (smooth, grainy, or other)

4. High Contrast Acuity at High Room Illumination [Baseline and 1 week]

   Logarithm of the Minimum Angle or Resolution (LogMAR) Chart

5. Lens Deposition [Baseline and 1 week]

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

6. Lens Problems [Baseline and 1 week]

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

7. Lens Centration [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

8. Lens Centration [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

9. Post-blink Movement [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)

10. Lens Tightness [Baseline and 1 week]

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

11. Visual Quality [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.

12. Ease of Lens Insertion [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

13. Ease of Lens Removal [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.

14. Overall Lens Fit [Baseline and 1 week]

    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)

15. Bulbar Hyperemia [Baseline and 1 week]

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

16. Limbal Hyperemia [Baseline and 1 week]

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

17. Corneal Dehydration Staining [1 week]

    Corneal Staining: Dehydration Staining: Yes/No

18. Corneal Staining (Extent) [Baseline and 1 week]

    Corneal staining extent, grade as % of each zone: C - Central, N - Nasal, T - Temporal, S - Superior, I - Interior

19. Conjunctival Indentation [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

20. Conjunctival Staining [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

-A person is eligible for inclusion in the study if he/she:

• Is at least 17 years of age and has full legal capacity to volunteer

• Has read and understood the information consent letter

• Is willing and able to follow instructions and maintain the appointment schedule

• Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses

• Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day.)

Exclusion Criteria:

-A person will be excluded from the study if he/she:

• Is participating in any concurrent clinical or research study

• Has any known active* ocular disease and/or infection

• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable**

• Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable

• Has known sensitivity to the diagnostic pharmaceuticals to be used in the study

• Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).

• Is aphakic

• Has undergone corneal refractive surgery.

For the purposes of this study, active* ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active. Participants will be excluded with significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 3 or above: corneal edema, tarsal abnormalities, and conjunctival injection) or active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)

For the purposes of this study, participants will be excluded**, if currently taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Contact Lens Research, University of Waterloo	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Lyndon Jones, PhD FCO, Center for Contact Lens Research, University of Waterloo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02500368
• Other Study ID Numbers: CV-15-36
• First Posted: Jul 16, 2015
• Last Update Posted: Jul 29, 2020
• Last Verified: Jul 1, 2020

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Pre-assignment Detail	One participant discontinued from the study as a screen failure before lens randomization.

Arm/Group Title	Silicone Hydrogel Lens (Test), Then Enfilcon A Lens (Control)	Enfilcon A Lens (Control), Then Silicone Hydrogel Lens (Test)
Arm/Group Description	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	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
Period Title: First Intervention (1 Week)
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0
Period Title: First Intervention (1 Week)
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Baseline Characteristics
Arm/Group Description	Participants were randomized to wear silicone hydrogel lens (test) or enfilcon A lens (control) for 1 week during the cross over study.
Overall Participants	41
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	24
Sex: Female, Male (Count of Participants)
Female	28 68.3%
Male	13 31.7%

Outcome Measures

1. Primary Outcome

Title	Comfort
Description	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.
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Silicone Hydrogel Lens (Test)	Enfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Measure Participants	40	40
Lens dispense at baseline	90 (11)	91 (10)
Lens insertion at 1 week	92 (9)	90 (14)
Overall comfort at 1 week	79 (15)	81 (13)

2. Primary Outcome

Title	Dryness
Description	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.
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Silicone Hydrogel Lens (Test)	Enfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Measure Participants	40	40
Lens dispense at baseline	94 (10)	94 (10)
Lens insertion at 1 week	94 (8)	92 (12)
Overall dryness at 1 week	75 (19)	78 (16)

3. Secondary Outcome

Title	Lens Wettability
Description	Grading scale 0-4, 0.25 steps, 0=excellent; 4=severely reduced.
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Silicone Hydrogel Lens (Test)	Enfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Measure Participants	40	40
Baseline	1.09 (0.60)	1.18 (0.87)
1 week	1.17 (0.76)	1.38 (0.79)

4. Secondary Outcome

Title	Surface Appearance
Description	Grade ratings category (smooth, grainy, or other)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Silicone Hydrogel Lens (Test)	Enfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Measure Participants	40	40
Measure Eyes	80	80
Smooth	76	70
Grainy	3	4
Other	1	6

5. Secondary Outcome

Title	Surface Appearance
Description	Grade ratings category (smooth, grainy, or other)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Silicone Hydrogel Lens (Test)	Enfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Measure Participants	40	40
Measure Eyes	80	80
Smooth	77	72
Grainy	1	4
Other	2	4

6. Secondary Outcome

Title	High Contrast Acuity at High Room Illumination
Description	Logarithm of the Minimum Angle or Resolution (LogMAR) Chart
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Silicone Hydrogel Lens (Test)	Enfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Measure Participants	40	40
Baseline	-0.10 (0.06)	-0.09 (0.04)
1 week	-0.10 (0.05)	-0.08 (0.06)

7. Secondary Outcome

Title	Lens Deposition
Description	Lens Deposits Scale 0-4, 0.25 steps. 0=excellent; 4=severely reduced
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Silicone Hydrogel Lens (Test)	Enfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Measure Participants	40	40
Baseline	0.06 (0.13)	0.12 (0.21)
1 week	0.28 (0.32)	0.38 (0.48)

8. Secondary Outcome

Title	Lens Problems
Description	Lenses were evaluated for defects, scratches, fibers, blue specks, and other findings.
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Silicone Hydrogel Lens (Test)	Enfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Measure Participants	40	40
Measure Lenses	80	80
Baseline, Blue specs	0	2
Baseline, Fibers	0	1
Baseline, Nick	0	1
1 week, Blue specs	0	2
1 week, Nick	0	1
1 week, Particles	0	3

9. Secondary Outcome

Title	Lens Centration
Description	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
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Silicone Hydrogel Lens (Test)	Enfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Measure Participants	40	40
Measure Eyes	80	80
No decentration	46	32
N	4	3
T	16	16
S	6	6
I	4	11
N/S	0	0
N/I	0	2
T/S	2	6
T/I	2	4

10. Secondary Outcome

Title	Lens Centration
Description	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
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Silicone Hydrogel Lens (Test)	Enfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Measure Participants	40	40
Measure Eyes	80	80
No decentration	43	51
N	1	1
T	12	6
S	8	4
I	10	9
N/S	1	0
N/I	1	0
T/S	3	2
T/I	1	7

11. Secondary Outcome

Title	Post-blink Movement
Description	Post-blink movement evaluated by estimating the distance the lens was moving immediately after a blink. Primary Gaze: (mm, 0.1 steps)
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Silicone Hydrogel Lens (Test)	Enfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Measure Participants	40	40
Baseline	0.26 (0.16)	0.25 (0.10)
1 week	0.24 (0.10)	0.27 (0.13)

12. Secondary Outcome

Title	Lens Tightness
Description	Lens tightness Scale 0%-100%, 0%=extremely loose fit, 50%=optimal push resistance and smooth return, 100%=no movement.
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Silicone Hydrogel Lens (Test)	Enfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Measure Participants	40	40
Baseline	50.9 (7.8)	48.1 (6.3)
1 week	48.8 (9.1)	47.9 (6.4)

13. Secondary Outcome

Title	Visual Quality
Description	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.
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Silicone Hydrogel Lens (Test)	Enfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Measure Participants	40	40
Lens dispense at baseline	94 (7)	93 (9)
Lens insertion at 1 week	95 (7)	94 (9)
Overall vision quality at 1 week	88 (12)	88 (13)

14. Secondary Outcome

Title	Ease of Lens Insertion
Description	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
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Silicone Hydrogel Lens (Test)	Enfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Measure Participants	40	40
Baseline	97 (5)	92 (10)
1 week	91 (9)	90 (10)

15. Secondary Outcome

Title	Ease of Lens Removal
Description	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.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Silicone Hydrogel Lens (Test)	Enfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Measure Participants	40	40
Mean (Standard Deviation) [units on a scale]	86 (15)	90 (12)

16. Secondary Outcome

Title	Overall Lens Fit
Description	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)
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Silicone Hydrogel Lens (Test)	Enfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Measure Participants	40	40
Baseline	3.35 (0.42)	3.33 (0.36)
1 week	3.36 (0.41)	3.38 (0.48)

17. Secondary Outcome

Title	Bulbar Hyperemia
Description	Bulbar hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Silicone Hydrogel Lens (Test)	Enfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Measure Participants	40	40
Baseline	1.96 (0.50)	1.96 (0.50)
1 week	1.87 (0.44)	1.95 (0.41)

18. Secondary Outcome

Title	Limbal Hyperemia
Description	Limbal hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Silicone Hydrogel Lens (Test)	Enfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Measure Participants	40	40
Baseline	1.76 (0.51)	1.76 (0.51)
1 week	1.68 (0.42)	1.71 (0.37)

19. Secondary Outcome

Title	Corneal Dehydration Staining
Description	Corneal Staining: Dehydration Staining: Yes/No
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Silicone Hydrogel Lens (Test)	Enfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Measure Participants	40	40
Both eyes	3 7.3%	1 NaN
One eye	2 4.9%	2 NaN

20. Secondary Outcome

Title	Corneal Staining (Extent)
Description	Corneal staining extent, grade as % of each zone: C - Central, N - Nasal, T - Temporal, S - Superior, I - Interior
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

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

21. Secondary Outcome

Title	Conjunctival Indentation
Description	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
Time Frame	Baseline and 1 week.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Silicone Hydrogel Lens (Test)	Enfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens	Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
Measure Participants	40	40
Nasal - baseline	0.01 (0.11)	0.01 (0.11)
Nasal - 1 week	0.36 (0.64)	0.01 (0.06)
Temporal - baseline	0.00 (0.00)	0.00 (0.00)
Temporal - 1 week	0.39 (0.68)	0.02 (0.10)
Superior - baseline	0.00 (0.00)	0.00 (0.00)
Superior - 1 week	0.21 (0.49)	0.02 (0.10)
Inferior - baseline	0.00 (0.00)	0.00 (0.00)
Inferior - 1 week	0.34 (0.67)	0.03 (0.15)

22. Secondary Outcome

Title	Conjunctival Staining
Description	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
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

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

Adverse Events

Time Frame	From dispense up to one week for each study lenses
Arm/Group Title	Silicone Hydrogel Lens (Test)		Enfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study. silicone hydrogel lens (test): contact lens		Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study. enfilcon A lens (control): contact lens
All Cause Mortality
	Silicone Hydrogel Lens (Test)		Enfilcon A Lens (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Silicone Hydrogel Lens (Test)		Enfilcon A Lens (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Silicone Hydrogel Lens (Test)		Enfilcon A Lens (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.