Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST® in Japan

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02103309
• Collaborator: (none)
• Enrollment: 42
• Arms: 2
• Duration (Months): 1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate lens centration and subjective impressions of DAILIES® AquaComfort Plus® (DACP) lenses compared to 1-DAY ACUVUE® MOIST® (1DAM) lenses in ball sports players.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error; Myopia; Myopic Astigmatism	Device: Nelfilcon A contact lenses; Device: Etafilcon A contact lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST®
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: DACP, then 1DAM Nelfilcon A contact lenses worn first, then etafilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.	Device: Nelfilcon A contact lenses; Other Names: DAILIES® AquaComfort® Plus DACP ; Device: Etafilcon A contact lenses; Other Names: 1-DAY ACUVUE® MOIST®
Other: 1DAM, then DACP Etafilcon A contact lenses worn first, then nelfilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.	Device: Nelfilcon A contact lenses; Other Names: DAILIES® AquaComfort® Plus DACP ; Device: Etafilcon A contact lenses; Other Names: 1-DAY ACUVUE® MOIST®

Outcome Measures

Primary Outcome Measures

1. Mean Investigator-Rated Lens Centration [After 1 week of wear]

   Lens centration was assessed by the investigator using slit-lamp microscopy and rated on a 5-point scale, where 0=Optimal and 4=Severe decentration. Both eyes contributed to the mean.

Secondary Outcome Measures

1. Mean Investigator-Rated Lens Fit [After 1 week of wear]

   Lens fit was assessed by the investigator and rated on a 5-point scale with -2=Unacceptable tight fit, -1=Acceptable tight fit, 0=Optimal, 1=Acceptable loose fit, and 2=Uacceptable loose fit. Both eyes contributed to the mean.

2. Average Subjective Ratings Score (Lens Handling and Overall Vision) [After 1 week of wear]

   The participant rated the handling and overall vision of the contact lenses on a 10-point scale, where 10=Excellent and 1=Poor. Both eyes contributed to the mean.

3. Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports) [After 1 week of wear]

   The participant rated the lens wearing conditions and visual performance of the contact lenses during ball sports on a 10-point scale, where 10=Agree and 1=Disagree. "Overall Vision" was rated with 10=Excellent and 1=Poor. Both eyes contributed to the mean.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 29 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Those who can understand the clinical study objectives and provide written informed consent. Legal representative or parental consent required if under age 20

• Those who regularly wear soft contact lenses in both eyes for a minimum of 8 hours per day and 5 days per week

• Those who play ball sports at least 1 day per week

• Those who need vision correction because of myopia or mild myopic astigmatism, who are eligible for use of the study device, and who can attain a visual acuity of at least 1.0 with correction

• Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• Those who regularly wear the study device

• Those who require ocular treatment with eye drops

• Those who have a condition contraindicating soft contact lens wear, such as eye irritation

• Those who have had ocular disorder or ocular surgery that may affect soft contact lens wear within 3 months before the start of the study

• Those who are participating in another clinical study or research or have a plan of such participation during the present study

• Women who are pregnant or intend to become pregnant during the study

• Other protocol-defined exclusion criteria may apply

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Lisa L. Zoota, MPH, CCRA, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02103309
• Other Study ID Numbers: M-13-050
• First Posted: Apr 3, 2014
• Last Update Posted: Oct 29, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by Alcon Research: Soft contact lenses; DACP
• Additional relevant MeSH terms: Astigmatism; Refractive Errors

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 5 study centers located in Japan.
Pre-assignment Detail	This reporting group includes all enrolled participants.

Arm/Group Title	DACP, Then 1DAM	1DAM, Then DACP
Arm/Group Description	Nelfilcon A contact lenses worn first, then etafilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.	Etafilcon A contact lenses worn first, then nelfilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
Period Title: Overall Study
STARTED	20	22
COMPLETED	20	22
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	DAILIES® AquaComfort Plus® and 1-Day ACUVUE® MOIST® contact lenses worn in a crossover assignment.
Overall Participants	42
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	22.5 (2.4)
Sex: Female, Male (Count of Participants)
Female	20 47.6%
Male	22 52.4%

Outcome Measures

1. Primary Outcome

Title	Mean Investigator-Rated Lens Centration
Description	Lens centration was assessed by the investigator using slit-lamp microscopy and rated on a 5-point scale, where 0=Optimal and 4=Severe decentration. Both eyes contributed to the mean.
Time Frame	After 1 week of wear

Outcome Measure Data

Analysis Population Description

This analysis population includes all enrolled participants minus missing data.

Arm/Group Title	DACP	1DAM
Arm/Group Description	Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.	Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
Measure Participants	41	39
Mean (Standard Deviation) [units on a scale]	0.34 (0.47)	0.73 (0.83)

2. Secondary Outcome

Title	Mean Investigator-Rated Lens Fit
Description	Lens fit was assessed by the investigator and rated on a 5-point scale with -2=Unacceptable tight fit, -1=Acceptable tight fit, 0=Optimal, 1=Acceptable loose fit, and 2=Uacceptable loose fit. Both eyes contributed to the mean.
Time Frame	After 1 week of wear

Outcome Measure Data

Analysis Population Description

This analysis population includes all enrolled participants minus missing data.

Arm/Group Title	DACP	1DAM
Arm/Group Description	Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.	Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
Measure Participants	41	39
Mean (Standard Deviation) [units on a scale]	0.24 (0.42)	0.28 (0.50)

3. Secondary Outcome

Title	Average Subjective Ratings Score (Lens Handling and Overall Vision)
Description	The participant rated the handling and overall vision of the contact lenses on a 10-point scale, where 10=Excellent and 1=Poor. Both eyes contributed to the mean.
Time Frame	After 1 week of wear

Outcome Measure Data

Analysis Population Description

This analysis population includes all enrolled participants minus missing data.

Arm/Group Title	DACP	1DAM
Arm/Group Description	Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.	Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
Measure Participants	42	42
Ease of insertion	7.8 (2.0)	6.4 (2.7)
Ease of removal	7.2 (2.5)	8.2 (1.9)
Overall vision	8.1 (1.9)	7.4 (2.2)

4. Secondary Outcome

Title	Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports)
Description	The participant rated the lens wearing conditions and visual performance of the contact lenses during ball sports on a 10-point scale, where 10=Agree and 1=Disagree. "Overall Vision" was rated with 10=Excellent and 1=Poor. Both eyes contributed to the mean.
Time Frame	After 1 week of wear

Outcome Measure Data

Analysis Population Description

This analysis population includes all enrolled participants minus missing data.

Arm/Group Title	DACP	1DAM
Arm/Group Description	Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.	Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
Measure Participants	42	42
Sense of discomfort	3.5 (2.6)	3.8 (2.6)
A lens comes off my eye	2.4 (2.2)	2.5 (2.2)
A lens becomes out of place	3.3 (2.5)	4.0 (2.9)
Improves my vision/widens my vision	6.3 (2.4)	5.8 (2.4)
My vision does not become blurry	6.3 (2.5)	6.0 (2.5)
Do not lose a sense of perspective/distance	6.8 (3.3)	6.4 (2.2)
Does not give me improper vision	7.4 (2.2)	7.1 (2.3)
Enables me to see clearly at important occasion	6.9 (2.4)	6.5 (2.2)
Improves my vision when playing sports	6.6 (2.5)	6.3 (2.0)
Overall vision	7.2 (2.1)	7.1 (1.9)

Adverse Events

Time Frame	Adverse events (AEs) were collected for the duration of the study (1 month). This analysis group includes (Safety Population). based on treatment-specific exposure
Adverse Event Reporting Description	An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in patients, users or other persons, whether or not related to the medical device.
Arm/Group Title	DACP		1DAM
Arm/Group Description	Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.		Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
All Cause Mortality
	DACP		1DAM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	DACP		1DAM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/42 (0%)
Other (Not Including Serious) Adverse Events
	DACP		1DAM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/42 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.