Comparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01254760
• Collaborator: (none)
• Enrollment: 79
• Arms: 2
• Duration (Months): 1

Study Details

Study Description

Brief Summary

The purpose of this trial is to evaluate and compare the clinical performance of two multifocal contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia; Myopia	Device: Nelfilcon A multifocal contact lens, investigational; Device: Nelfilcon A multifocal contact lens, commercial	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: Investigational multifocal / Commercial multifocal Investigational multifocal contact lenses worn first, with commercial multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.	Device: Nelfilcon A multifocal contact lens, investigational; Investigational, soft, multifocal contact lens for daily wear, daily disposable use.; Device: Nelfilcon A multifocal contact lens, commercial; Commercially marketed, soft, multifocal contact lens FDA-approved for daily wear, daily disposable use.; Other Names: Focus® DAILIES® Progressive
Other: Commercial multifocal / Investigational multifocal Commercial multifocal contact lenses worn first, with investigational multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.	Device: Nelfilcon A multifocal contact lens, investigational; Investigational, soft, multifocal contact lens for daily wear, daily disposable use.; Device: Nelfilcon A multifocal contact lens, commercial; Commercially marketed, soft, multifocal contact lens FDA-approved for daily wear, daily disposable use.; Other Names: Focus® DAILIES® Progressive

Outcome Measures

Primary Outcome Measures

1. End of Day Comfort [5 days of wear, lenses replaced daily]

   End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.

2. End of Day Dryness [5 days of wear, lenses replaced daily]

   End of day dryness was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.

3. Handling at Removal [5 days of wear, lenses replaced daily]

   Handling at removal was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Handling at removal was measured on a 10-point scale, with 1 being poor/difficult and 10 being excellent/easy.

4. Overall Vision [5 days of wear, lenses replaced daily]

   Overall vision was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.

Secondary Outcome Measures

1. Overall Fit [Day 5, lenses replaced daily]

   Overall lens fit was assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was assessed by eye and graded on a 5-point scale, with 2=unacceptably loose, 1= acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight

Eligibility Criteria

Criteria

• Ages Eligible for Study: 41 Years to 68 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 41 to 68 (inclusive).

• Spectacle add between +0.75 and +2.75D (inclusive).

• Habitual spectacle prescription ≤ 1.00DC (cyl).

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Eye injury or surgery within twelve weeks of enrollment.

• Pre-existing ocular irritation that would preclude contact lens fitting.

• Currently enrolled in a clinical trial.

• Prior refractive surgery.

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• CIBA VISION

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CIBA VISION
• ClinicalTrials.gov Identifier: NCT01254760
• Other Study ID Numbers: P-416-C-001 Sub 04
• First Posted: Dec 7, 2010
• Last Update Posted: Jul 10, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Presbyopia

Study Results

Participant Flow

Recruitment Details	A total of 79 participants were recruited at 7 US sites from December 3, 2010, to January 20, 2011.
Pre-assignment Detail	Seven participants were enrolled in the study but not dispensed due to failed inclusion/exclusion criteria (2); unsatisfactory vision (2); unacceptable comfort (1); and subject withdrawal (2). These participants are included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.

Arm/Group Title	Investigational Multifocal / Commercial Multifocal	Commercial Multifocal / Investigational Multifocal
Arm/Group Description	Investigational multifocal contact lenses worn first, with commercial multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.	Commercial multifocal contact lenses worn first, with investigational multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
Period Title: First Period, 5 Days of Wear
STARTED	34	38
COMPLETED	34	38
NOT COMPLETED	0	0
Period Title: First Period, 5 Days of Wear
STARTED	34	38
COMPLETED	34	38
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	This reporting group includes all enrolled and dispensed participants.
Overall Participants	72
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.1 (5.7)
Sex: Female, Male (Count of Participants)
Female	53 73.6%
Male	19 26.4%

Outcome Measures

1. Primary Outcome

Title	End of Day Comfort
Description	End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	5 days of wear, lenses replaced daily

Outcome Measure Data

Analysis Population Description

Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Arm/Group Title	Nelfilcon A Investigational	Nelfilcon A Commercial
Arm/Group Description	Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days	Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
Measure Participants	71	71
Mean (Standard Deviation) [Units on a scale]	7.7 (2.2)	7.2 (2.3)

2. Primary Outcome

Title	End of Day Dryness
Description	End of day dryness was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
Time Frame	5 days of wear, lenses replaced daily

Outcome Measure Data

Analysis Population Description

Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Arm/Group Title	Nelfilcon A Investigational	Nelfilcon A Commercial
Arm/Group Description	Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days	Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
Measure Participants	71	71
Mean (Standard Deviation) [Units on a Scale]	7.2 (2.5)	6.9 (2.5)

3. Primary Outcome

Title	Handling at Removal
Description	Handling at removal was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Handling at removal was measured on a 10-point scale, with 1 being poor/difficult and 10 being excellent/easy.
Time Frame	5 days of wear, lenses replaced daily

Outcome Measure Data

Analysis Population Description

Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Arm/Group Title	Nelfilcon A Investigational	Nelfilcon A Commercial
Arm/Group Description	Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days	Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
Measure Participants	71	70
Mean (Standard Deviation) [Units on a Scale]	8.7 (1.6)	8.2 (2.1)

4. Primary Outcome

Title	Overall Vision
Description	Overall vision was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	5 days of wear, lenses replaced daily

Outcome Measure Data

Analysis Population Description

Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Arm/Group Title	Nelfilcon A Investigational	Nelfilcon A Commercial
Arm/Group Description	Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days	Nelfilcon A commercial contact lenses worn in bilaterally on a daily wear, daily disposable basis for 5 days
Measure Participants	70	71
Mean (Standard Deviation) [Units on a Scale]	7.2 (1.9)	6.2 (2.1)

5. Secondary Outcome

Title	Overall Fit
Description	Overall lens fit was assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was assessed by eye and graded on a 5-point scale, with 2=unacceptably loose, 1= acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight
Time Frame	Day 5, lenses replaced daily

Outcome Measure Data

Analysis Population Description

Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Arm/Group Title	Nelfilcon A Investigational	Nelfilcon A Commercial
Arm/Group Description	Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days	Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
Measure Participants	69	69
Measure Eyes	138	138
Mean (Standard Deviation) [Units on a Scale]	0.0 (0.5)	-0.1 (0.6)

Adverse Events

Time Frame	Adverse event data were collected for the duration of the trial: 53 days
Adverse Event Reporting Description	This reporting group includes all enrolled and exposed participants.
Arm/Group Title	Nelfilcon A Investigational		Nelfilcon A Commercial
Arm/Group Description	Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 5 days		Nelfilcon A commercial contact lenses worn in both eyes on a daily wear, daily disposable basis for 5 days
All Cause Mortality
	Nelfilcon A Investigational		Nelfilcon A Commercial
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Nelfilcon A Investigational		Nelfilcon A Commercial
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/77 (0%)		0/77 (0%)
Other (Not Including Serious) Adverse Events
	Nelfilcon A Investigational		Nelfilcon A Commercial
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/77 (0%)		0/77 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.