Clinical Evaluation of Daily Disposable Contact Lenses

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02097030
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 3
• Duration (Months): 1
• Patients Per Site Per Month: 34.4

Study Details

Study Description

Brief Summary

The objective of the study is to compare the overall subjective preference of filcon II 3 daily disposable silicone hyrogel contact lenses compared to etafilcon A and nelfilcon A daily disposable conventional hydrogel contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: filcon II 3; Device: etafilcon A; Device: nelfilcon A	N/A

Detailed Description

Double-masked, randomised, controlled crossover trial. Subjects were randomized to wear one or the other of the conventional hydriogel lenses; all subjects wore the filcon II 3 lenses. The first randomly assigned lens type was worn for 3 days, with daily replacement, followed by 3 days of wear of the other lens type, with daily replacement.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: Single-Center Clinical Evaluation of Daily Disposable Contact Lenses
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: etafilcon A lens Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types.	Device: etafilcon A; Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.; Other Names: Hydrogel Daily Disposable Contact Lens
Active Comparator: nelfilcon A lens Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types.	Device: nelfilcon A; Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.; Other Names: Hydrogel Daily Disposable Contact Lens
Active Comparator: filcon II 3 lens Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types.	Device: filcon II 3; Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.; Other Names: Silicone Hydrogel Daily Disposable Contact Lens

Outcome Measures

Primary Outcome Measures

1. Overall Lens Preference - All Study Lenses [Study Exit]

   Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair of lenses. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).

2. Overall Lens Preference - Hydrogel vs. Filcon II 3 [Study Exit]

   Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).

Secondary Outcome Measures

1. Subjective Response for Comfort [Baseline and 3 day follow-up]

   Participant's subjective response for comfort measured at baseline and 3 day follow-up. (Continuous Comfort Scale 0-100, 0=cannot be worn/causes pain, 100=cannot be felt ever)

2. Subjective Response for Vision [Baseline and 3 day follow-up]

   Participant's subjective response for vision measured at baseline and at 3 day follow-up of daily disposable wear of lenses. (Vision Scale 0-100, 0=very blurry, 100=very clear).

3. Subjective Response for Insertion [Baseline]

   Participant's subjective response for insertion measured at baseline. (Insertion Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).

4. Subjective Response for Handling (Insertion and Removal) [3 days follow-up]

   Participant's subjective response for handling (insertion and removal) measured at 3 day follow-up of daily disposable wear of lenses. (Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).

5. Subjective Response for Dryness [3 Days Follow-up]

   Participant's subjective response for dryness, measured at baseline and after 3 day follow-up of daily disposable wear of lenses. (Dryness Scale 0-100, 0=Cannot be worn/extremely dry, 100=no dryness experienced at any time).

6. Overall Satisfaction, Vision [3 Days Follow-up]

   Participant's subjective response for overall vision satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.

7. Overall Satisfaction, Comfort [3 Days Follow-up]

   Participant's subjective response for overall comfort satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.

8. Overall Satisfaction, Handling [3 Days]

   Participant's subjective response for overall handling satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.

9. Overall Satisfaction, Dryness [3 Days Follow-up]

   Participant's subjective response for overall dryness satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.

10. Overall Satisfaction [3 Days Follow-up]

    Participant's subjective response for overall satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.

11. Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up) [Baseline and 3 days follow-up]

    The investigator's objective assessment for contact lens fit and performance - wettability. Measured at baseline (10-15mins settling) for both study pairs. Wettability (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced).

12. Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up) [Baseline and 3 days follow-up]

    The investigator's objective assessment for contact lens fit and performance - deposits. Measured at baseline (10-15mins settling) for both study pairs. Deposits (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced);

13. Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up) [Baseline and 3 day follow-up]

    The investigator's objective assessment for contact lens fit and performance - debris. Measured at baseline (10-15mins settling) for both study pairs. (Debris scale 0-4; 0.25 steps; 0=no debris, 4=significant debris)

14. Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up) [Baseline and 3 days follow-up]

    The investigator's objective assessment for contact lens fit and performance - movement. Measured at baseline (10-15mins settling) for both study pairs. Movement (scale in millimeters).

15. Lens Fit and Performance - Fit Acceptance [Baseline and 3 day follow-up]

    The investigator's objective assessment for contact lens fit and performance - fit acceptance. Measured at baseline and 3 day follow-up (10-15mins settling) for both study pairs. Fit acceptance (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).

16. Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up) [Baseline and 3 day follow-up]

    The investigator's objective assessment for contact lens fit and performance - tightness. Measured at baseline (10-15mins settling) for both study pairs. Tightness (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).

17. Ocular Health - Biomicroscopy [3 Days Follow-up]

    The investigator's objective assessment of ocular health assessed for each study Pair after 3 days wear by biomicroscopy. Bulbar and Limbal Hyperemia; Corneal Staining Type, Extent and Depth, Conjunctival Staining and Indentation. BrienHolden Vision Institute Continuous Scale: 1-4, 0.5 steps (1=Very, 2=Slight, 3=Moderate, 4=Severe)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Is between 18 and 40 years of age (inclusive)

• Has had a self-reported visual exam in the last two years

• Is an adapted soft CL wearer

• Must be able to wear their lenses at least 3 full days, 10 hours per day, assuming there are no contraindications for doing so

• Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)

• Has less than 1.25 D spectacle cylinder in each eye.

• Baseline vision of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.

• Is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye

• Has clear corneas and no active ocular disease

• Has read, understood and signed the information consent letter

• Is willing to comply with the wear schedule (at least 3 full days)

• Is willing to comply with the visit schedule

Exclusion Criteria:

• Has never worn contact lenses before.

• Currently wears rigid gas permeable contact lenses.

• Has a history of not achieving comfortable CL wear (3 days per week; > 8 hours/day)

• Has a CL prescription outside the range of - 1.00 to -6.00D

• Has a spectacle cylinder greater than -1.25D of cylinder in either eye.

• Has best corrected spectacle distance vision worse then 20/25 in either eye.

• Has any systemic disease affecting ocular health.

• Is using any systemic or topical medications, (includes rewetting drops, artificial tears and allergy drops), that will affect ocular health. Occasional use is acceptable but not during the trial.

• Has any ocular pathology or severe insufficiency of lacrimal secretion

• Has persistent, clinically significant corneal or conjunctival staining

• Has active neovascularization or any central corneal scars.

• Is aphakic.

• Is presbyopic.

• Has undergone corneal refractive surgery.

• Is participating in any other type of eye related clinical or research study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Berkeley Clinical Research Center (UCB-CRC)	Berkeley	California	United States	94720-2020

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Meng C Lin, OD, PhD, University of California, Berkeley

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02097030
• Other Study ID Numbers: EX-MKTG-46
• First Posted: Mar 26, 2014
• Last Update Posted: Jul 31, 2020
• Last Verified: Jul 1, 2020

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	Single center evaluation. Thirty five subjects were recruited and 30 subjects completed the trial.
Pre-assignment Detail	Three participants were enrolled in the study but did not meet inclusion criteria, therefore discontinued before lens randomization.

Arm/Group Title	Etafilcon A, Then Filcon II 3	Nelfilcon A, Then Filcon II 3
Arm/Group Description	Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days. etafilcon A: contact lens filcon II 3: contact lens	Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days. nelfilcon A: contact lens filcon II 3: contact lens
Period Title: First Intervention (3 Days)
STARTED	15	17
COMPLETED	14	16
NOT COMPLETED	1	1
Period Title: First Intervention (3 Days)
STARTED	14	16
COMPLETED	14	16
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Etafilcon A, Then Filcon II 3	Nelfilcon A, Then Filcon II 3	Total
Arm/Group Description	Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days. etafilcon A: contact lens filcon II 3: contact lens	Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days. nelfilcon A: contact lens filcon II 3: contact lens	Total of all reporting groups
Overall Participants	14	16	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	21.5 (4.9)	21.2 (5.0)	21.4 (5.0)
Sex: Female, Male (Count of Participants)
Female	12 85.7%	14 87.5%	26 86.7%
Male	2 14.3%	2 12.5%	4 13.3%

Outcome Measures

1. Primary Outcome

Title	Overall Lens Preference - All Study Lenses
Description	Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair of lenses. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).
Time Frame	Study Exit

Outcome Measure Data

Analysis Population Description

Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.

Arm/Group Title	Nelfilcon A	Etafilcon A	Filcon II 3
Arm/Group Description	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
Measure Participants	16	14	30
Strongly Prefer	5 35.7%	3 18.8%	8 26.7%
Slightly Prefer	4 28.6%	3 18.8%	7 23.3%

2. Primary Outcome

Title	Overall Lens Preference - Hydrogel vs. Filcon II 3
Description	Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).
Time Frame	Study Exit

Outcome Measure Data

Analysis Population Description

30 subjects

Arm/Group Title	Hydrogel	Filcon II 3
Arm/Group Description	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A. (hydrogel: nelfilcon A, etafilcon A) (silicone hydrogel: filcon II 3)	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A. (hydrogel: nelfilcon A, etafilcon A) (silicone hydrogel: filcon II 3)
Measure Participants	30	30
Strongly Prefer	8 57.1%	8 50%
Slightly Prefer	7 50%	7 43.8%

3. Secondary Outcome

Title	Subjective Response for Comfort
Description	Participant's subjective response for comfort measured at baseline and 3 day follow-up. (Continuous Comfort Scale 0-100, 0=cannot be worn/causes pain, 100=cannot be felt ever)
Time Frame	Baseline and 3 day follow-up

Outcome Measure Data

Analysis Population Description

Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.

Arm/Group Title	Nelfilcon A	Etafilcon A	Filcon II 3
Arm/Group Description	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
Measure Participants	16	14	30
Baseline	90.3 (15.9)	94.1 (8.7)	93.2 (9.5)
3 day follow up	84.5 (12.2)	82.0 (16.3)	81.5 (20.1)

4. Secondary Outcome

Title	Subjective Response for Vision
Description	Participant's subjective response for vision measured at baseline and at 3 day follow-up of daily disposable wear of lenses. (Vision Scale 0-100, 0=very blurry, 100=very clear).
Time Frame	Baseline and 3 day follow-up

Outcome Measure Data

Analysis Population Description

Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.

Arm/Group Title	Nelfilcon A	Etafilcon A	Filcon II 3
Arm/Group Description	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
Measure Participants	16	14	30
Baseline	93.8 (8.2)	93.0 (9.6)	94.1 (6.1)
3 day follow up	94.8 (5.4)	90.6 (15.8)	95.2 (5.1)

5. Secondary Outcome

Title	Subjective Response for Insertion
Description	Participant's subjective response for insertion measured at baseline. (Insertion Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.

Arm/Group Title	Nelfilcon A	Etafilcon A	Filcon II 3
Arm/Group Description	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
Measure Participants	16	14	30
Mean (Standard Deviation) [units on a scale]	94.6 (8.5)	86.4 (18.4)	91.0 (15.1)

6. Secondary Outcome

Title	Subjective Response for Handling (Insertion and Removal)
Description	Participant's subjective response for handling (insertion and removal) measured at 3 day follow-up of daily disposable wear of lenses. (Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).
Time Frame	3 days follow-up

Outcome Measure Data

Analysis Population Description

Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.

Arm/Group Title	Nelfilcon A	Etafilcon A	Filcon II 3
Arm/Group Description	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
Measure Participants	16	14	30
Insertion	92.9 (11.6)	74.1 (23.6)	91.3 (10.1)
Removal	88.6 (14.8)	94.8 (8.0)	93.9 (11.8)

7. Secondary Outcome

Title	Subjective Response for Dryness
Description	Participant's subjective response for dryness, measured at baseline and after 3 day follow-up of daily disposable wear of lenses. (Dryness Scale 0-100, 0=Cannot be worn/extremely dry, 100=no dryness experienced at any time).
Time Frame	3 Days Follow-up

Outcome Measure Data

Analysis Population Description

Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.

Arm/Group Title	Nelfilcon A	Etafilcon A	Filcon II 3
Arm/Group Description	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
Measure Participants	16	14	30
Mean (Standard Deviation) [units on a scale]	80.6 (16.8)	81.6 (19.0)	76.4 (21.5)

8. Secondary Outcome

Title	Overall Satisfaction, Vision
Description	Participant's subjective response for overall vision satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Time Frame	3 Days Follow-up

Outcome Measure Data

Analysis Population Description

Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.

Arm/Group Title	Nelfilcon A	Etafilcon A	Filcon II 3
Arm/Group Description	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
Measure Participants	16	14	30
Completely Dissatisfied	0 0%	0 0%	0 0%
Somewhat Dissatisfied	0 0%	1 6.3%	0 0%
Somewhat Satisfied	2 14.3%	2 12.5%	6 20%
Completely Satisfied	14 100%	11 68.8%	24 80%

9. Secondary Outcome

Title	Overall Satisfaction, Comfort
Description	Participant's subjective response for overall comfort satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Time Frame	3 Days Follow-up

Outcome Measure Data

Analysis Population Description

Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.

Arm/Group Title	Nelfilcon A	Etafilcon A	Filcon II 3
Arm/Group Description	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
Measure Participants	16	14	30
Completely Dissatisfied	0 0%	0 0%	0 0%
Somewhat Dissatisfied	3 21.4%	1 6.3%	5 16.7%
Somewhat Satisfied	5 35.7%	8 50%	9 30%
Completely Satisfied	8 57.1%	5 31.3%	16 53.3%

10. Secondary Outcome

Title	Overall Satisfaction, Handling
Description	Participant's subjective response for overall handling satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Time Frame	3 Days

Outcome Measure Data

Analysis Population Description

Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.

Arm/Group Title	Nelfilcon A	Etafilcon A	Filcon II 3
Arm/Group Description	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
Measure Participants	16	14	30
Completely Dissatisfied	0 0%	0 0%	0 0%
Somewhat Dissatisfied	1 7.1%	4 25%	4 13.3%
Somewhat Satisfied	6 42.9%	3 18.8%	10 33.3%
Completely Satisfied	9 64.3%	7 43.8%	16 53.3%

11. Secondary Outcome

Title	Overall Satisfaction, Dryness
Description	Participant's subjective response for overall dryness satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Time Frame	3 Days Follow-up

Outcome Measure Data

Analysis Population Description

Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.

Arm/Group Title	Nelfilcon A	Etafilcon A	Filcon II 3
Arm/Group Description	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
Measure Participants	16	14	30
Completely Dissatisfied	1 7.1%	0 0%	2 6.7%
Somewhat Dissatisfied	4 28.6%	3 18.8%	5 16.7%
Somewhat Satisfied	6 42.9%	5 31.3%	12 40%
Completely Satisfied	5 35.7%	6 37.5%	11 36.7%

12. Secondary Outcome

Title	Overall Satisfaction
Description	Participant's subjective response for overall satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Time Frame	3 Days Follow-up

Outcome Measure Data

Analysis Population Description

Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.

Arm/Group Title	Nelfilcon A	Etafilcon A	Filcon II 3
Arm/Group Description	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
Measure Participants	16	14	30
Completely Dissatisfied	0 0%	0 0%	1 3.3%
Somewhat Dissatisfied	1 7.1%	1 6.3%	3 10%
Somewhat Satisfied	8 57.1%	9 56.3%	11 36.7%
Completely Satisfied	7 50%	4 25%	15 50%

13. Secondary Outcome

Title	Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)
Description	The investigator's objective assessment for contact lens fit and performance - wettability. Measured at baseline (10-15mins settling) for both study pairs. Wettability (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced).
Time Frame	Baseline and 3 days follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nelfilcon A	Etafilcon A	Filcon II 3
Arm/Group Description	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
Measure Participants	16	14	30
Baseline	3.5 (0.3)	3.3 (0.5)	3.4 (0.4)
3 days follow up	3.6 (0.2)	3.2 (0.6)	3.5 (0.4)

14. Secondary Outcome

Title	Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)
Description	The investigator's objective assessment for contact lens fit and performance - deposits. Measured at baseline (10-15mins settling) for both study pairs. Deposits (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced);
Time Frame	Baseline and 3 days follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nelfilcon A	Etafilcon A	Filcon II 3
Arm/Group Description	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
Measure Participants	16	14	30
Baseline	0.0 (0.0)	0.1 (0.3)	0.0 (0.0)
3 days follow up	0.0 (0.0)	0.0 (0.0)	0.0 (0.0)

15. Secondary Outcome

Title	Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up)
Description	The investigator's objective assessment for contact lens fit and performance - debris. Measured at baseline (10-15mins settling) for both study pairs. (Debris scale 0-4; 0.25 steps; 0=no debris, 4=significant debris)
Time Frame	Baseline and 3 day follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nelfilcon A	Etafilcon A	Filcon II 3
Arm/Group Description	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
Measure Participants	16	14	30
Baseline	0.0 (0.0)	0.0 (0.0)	0.0 (0.0)
3 days follow up	0.0 (0.0)	0.0 (0.0)	0.1 (0.6)

16. Secondary Outcome

Title	Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up)
Description	The investigator's objective assessment for contact lens fit and performance - movement. Measured at baseline (10-15mins settling) for both study pairs. Movement (scale in millimeters).
Time Frame	Baseline and 3 days follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nelfilcon A	Etafilcon A	Filcon II 3
Arm/Group Description	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
Measure Participants	16	14	30
Baseline	0.3 (0.2)	0.3 (0.2)	0.3 (0.1)
3 days follow up	0.2 (0.2)	0.3 (0.2)	0.3 (0.2)

17. Secondary Outcome

Title	Lens Fit and Performance - Fit Acceptance
Description	The investigator's objective assessment for contact lens fit and performance - fit acceptance. Measured at baseline and 3 day follow-up (10-15mins settling) for both study pairs. Fit acceptance (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).
Time Frame	Baseline and 3 day follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nelfilcon A	Etafilcon A	Filcon II 3
Arm/Group Description	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
Measure Participants	16	14	30
Baseline	3.6 (0.2)	3.6 (0.2)	3.7 (0.2)
3 days follow up	3.6 (0.3)	3.6 (0.2)	3.7 (0.2)

18. Secondary Outcome

Title	Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)
Description	The investigator's objective assessment for contact lens fit and performance - tightness. Measured at baseline (10-15mins settling) for both study pairs. Tightness (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).
Time Frame	Baseline and 3 day follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nelfilcon A	Etafilcon A	Filcon II 3
Arm/Group Description	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
Measure Participants	16	14	30
Baseline	54.0 (12.0)	56.0 (11.0)	53.0 (12)
3 days follow up	58.0 (12)	55 (12.0)	54 (11)

19. Secondary Outcome

Title	Ocular Health - Biomicroscopy
Description	The investigator's objective assessment of ocular health assessed for each study Pair after 3 days wear by biomicroscopy. Bulbar and Limbal Hyperemia; Corneal Staining Type, Extent and Depth, Conjunctival Staining and Indentation. BrienHolden Vision Institute Continuous Scale: 1-4, 0.5 steps (1=Very, 2=Slight, 3=Moderate, 4=Severe)
Time Frame	3 Days Follow-up

Outcome Measure Data

Analysis Population Description

Only right eye data shown. Left eye data virtually identical. One subject had non-contact lens related adverse event in the nelfilcon A group. Subject temporarily discontinued and went on to complete the study.

Arm/Group Title	Nelfilcon A	Etafilcon A	Filcon II 3
Arm/Group Description	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
Measure Participants	16	14	30
Bulbar Hyperemia (Nasal)	0.88 (0.2)	0.96 (0.3)	0.95 (0.4)
Bulbar Hyperemia (Temporal)	0.81 (0.3)	0.96 (0.2)	0.98 (0.4)
Bulbar Hyperemia (Superior)	0.63 (0.4)	0.64 (0.5)	0.72 (0.5)
Bulbar Hyperemia (Inferior)	0.72 (0.4)	0.64 (0.5)	0.75 (0.5)
Limbal Hyperemia (Nasal)	0.53 (0.5)	0.96 (0.7)	0.47 (0.6)
Limbal Hyperemia (Temporal)	0.44 (0.4)	0.89 (0.7)	0.38 (0.5)
Limbal Hyperemia (Superior)	0.38 (0.4)	0.68 (0.7)	0.30 (0.4)
Limbal Hyperemia (Inferior)	0.41 (0.5)	0.75 (0.8)	0.33 (0.5)
Corneal Staining Type (Central)	0.00 (0.0)	0.18 (0.5)	0.17 (0.6)
Corneal Staining Type (Nasal)	0.19 (0.8)	0.14 (0.5)	0.07 (0.4)
Corneal Staining Type (Temporal)	0.16 (0.4)	0.25 (0.7)	0.32 (0.8)
Corneal Staining Type (Superior)	0.34 (0.7)	0.07 (0.3)	0.38 (0.8)
Corneal Staining Type (Inferior)	0.50 (1.0)	0.50 (0.9)	0.67 (0.9)
Corneal Staining Extent (Central)	0.00 (0.0)	0.07 (0.2)	0.08 (0.3)
Corneal Staining Extent (Nasal)	0.03 (0.1)	0.04 (0.1)	0.02 (0.1)
Corneal Staining Extent (Temporal)	0.09 (0.3)	0.11 (0.3)	0.10 (0.2)
Corneal Staining Extent (Superior)	0.22 (0.4)	0.04 (0.1)	0.22 (0.5)
Corneal Staining Extent (Inferior)	0.41 (0.7)	0.32 (0.6)	0.38 (0.6)
Corneal Staining Depth (Central)	0.00 (0.0)	0.14 (0.4)	0.10 (0.3)
Corneal Staining Depth (Nasal)	0.06 (0.3)	0.07 (0.3)	0.03 (0.2)
Corneal Staining Depth (Temporal)	0.13 (0.3)	0.14 (0.4)	0.17 (0.4)
Corneal Staining Depth (Superior)	.025 (0.5)	0.07 (0.3)	0.20 (0.4)
Corneal Staining Depth (Inferior)	0.25 (0.5)	0.29 (0.5)	0.40 (0.5)
Conjunctival Staining (Nasal)	0.34 (0.6)	1.29 (1.2)	1.65 (0.9)
Conjunctival Staining (Temporal)	0.28 (0.5)	0.68 (0.9)	1.65 (0.9)
Conjunctival Staining (Superior)	0.13 (0.3)	0.04 (0.1)	1.48 (0.8)
Conjunctival Staining (Inferior)	0.19 (0.4)	0.64 (0.9)	1.55 (0.8)
Conjunctival Indent (Nasal)	0.00 (0.0)	0.00 (0.0)	0.28 (0.5)
Conjunctival Indent (Temporal)	0.00 (0.0)	0.00 (0.0)	0.28 (0.5)
Conjunctival Indent (Superior)	0.06 (0.3)	0.00 (0.0)	0.22 (0.5)
Conjunctival Indent (Inferior)	0.06 (0.3)	0.00 (0.0)	0.20 (0.5)

Adverse Events

Time Frame	From dispense up to 3 days for each study lenses
Arm/Group Title	Nelfilcon A		Etafilcon A		Filcon II 3
Arm/Group Description	Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A		Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A		Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
All Cause Mortality
	Nelfilcon A		Etafilcon A		Filcon II 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Nelfilcon A		Etafilcon A		Filcon II 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/14 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Nelfilcon A		Etafilcon A		Filcon II 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/16 (6.3%)		0/14 (0%)		0/30 (0%)
Eye disorders
Non-lens related	1/16 (6.3%)	1	0/14 (0%)	0	0/30 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.