Clinical Evaluation of an Investigational Soft Contact Lens

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01254747
• Collaborator: (none)
• Enrollment: 130
• Locations: 2
• Arms: 4
• Duration (Days): 30
• Patients Per Site: 65
• Patients Per Site Per Month: 65.9

Study Details

Study Description

Brief Summary

The purpose of this 4-week dispensing trial is to evaluate and compare an investigational soft contact lens worn on a daily disposable basis with three other soft contact lenses also worn on a daily disposable basis.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Delefilcon A contact lens; Device: Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX); Device: Nelfilcon A contact lens (DAILIES AquaComfort Plus); Device: Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Delefilcon A Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Device: Delefilcon A contact lens; Investigational silicone hydrogel, single vision contact lens for daily wear, daily disposable use; Other Names: DAILIES TOTAL1®
Active Comparator: Lotrafilcon B Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Device: Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX); Commercially marketed silicone hydrogel, single vision contact lens for daily wear, daily disposable use; Other Names: O2 OPTIX® AIR OPTIX®
Active Comparator: Nelfilcon A Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Device: Nelfilcon A contact lens (DAILIES AquaComfort Plus); Commercially marketed hydrogel, single vision contact lens for daily wear, daily disposable use; Other Names: DAILIES® AquaComfort Plus®
Active Comparator: Narafilcon A Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Device: Narafilcon A contact lens (1-DAY ACUVUE TRUEYE); Commercially marketed (Europe) silicone hydrogel, single vision contact lens for daily wear, daily disposable use; Other Names: 1-DAY ACUVUE® TRUEYE™

Outcome Measures

Primary Outcome Measures

1. Overall Comfort [4 weeks]

   Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.

2. Vision Quality During the Day [4 weeks]

   Vision quality during the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Vision quality during the day was measured on a 10-point scale, with 1 being poor and 10 being excellent.

3. Overall Handling [4 weeks]

   Overall handling was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall handling was measured on a 10-point scale, with 1 being poor and 10 being excellent.

4. Dryness Throughout the Day [4 weeks]

   Dryness throughout the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Dryness throughout the day was measured on a 10-point scale, with 1 being very dry and 10 being not dry.

5. Average Daily Wear Time [4 weeks]

   Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear.

Secondary Outcome Measures

1. Lens Fit [4 weeks]

   Lens fit was assessed by the investigator for each eye using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptable loose, 1=acceptable loose, 0=optimal, -1=acceptable tight, and -2=unacceptable tight.

2. Corrected Visual Acuity [4 weeks]

   Corrected visual acuity was tested for each eye while the participant read distant charts in normal lighting. Corrected visual acuity was measured with a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.

3. Overall Satisfaction [4 weeks]

   Overall satisfaction was recorded on a 5-point Likert scale as a single, retrospective evaluation of 4 weeks of wear. The following scale was used: 2=very satisfied, 1=somewhat satisfied, 0=neither, -1=somewhat dissatisfied, and -2=very dissatisfied.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Germany: Be of legal age.

• USA: Be of legal age or, if under legal age, have written consent of parent/guardian to participate and sign informed assent.

• Sign Informed Consent.

• Wear soft contact lenses for at least 3 months prior to the study.

• Wear soft contact lenses on a daily disposable basis, daily wear basis, or occasional extended wear basis.

• Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

• Eye injury or surgery within twelve weeks prior to enrollment.

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

• Currently enrolled in any clinical trial.

• Regularly wear contact lenses on an extended/overnight basis.

• Germany: pregnant or lactating.

• Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CIBA VISION Research Clinic	Duluth	Georgia	United States	30097
2	CIBA VISION Research Clinic	Grosswallstadt		Germany	63868

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: NCT01254747
• Other Study ID Numbers: P-347-C-003v2s2v2
• First Posted: Dec 7, 2010
• Last Update Posted: Jul 10, 2012
• Last Verified: Apr 1, 2012

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	Participants were recruited and enrolled from 1 US study center and 1 German study center.
Pre-assignment Detail	This reporting group includes all enrolled and dispensed participants (129). One US participant was enrolled, but not dispensed.

Arm/Group Title	Delefilcon A	Lotrafilcon B	Nelfilcon A	Narafilcon A
Arm/Group Description	Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Period Title: Overall Study
STARTED	40	29	30	30
COMPLETED	40	23	26	28
NOT COMPLETED	0	6	4	2

Baseline Characteristics

Arm/Group Title	Delefilcon A	Lotrafilcon B	Nelfilcon A	Narafilcon A	Total
Arm/Group Description	Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Total of all reporting groups
Overall Participants	40	29	30	30	129
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.7 (10.4)	35.6 (11.4)	38.4 (10.6)	37.0 (11.4)	36.6 (10.8)
Sex: Female, Male (Count of Participants)
Female	32 80%	19 65.5%	24 80%	20 66.7%	95 73.6%
Male	8 20%	10 34.5%	6 20%	10 33.3%	34 26.4%

Outcome Measures

1. Primary Outcome

Title	Overall Comfort
Description	Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Delefilcon A	Lotrafilcon B	Nelfilcon A	Narafilcon A
Arm/Group Description	Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Measure Participants	40	23	26	28
Mean (Standard Deviation) [Units on a scale]	9.5 (0.7)	7.9 (1.6)	9.0 (0.9)	8.6 (1.2)

2. Primary Outcome

Title	Vision Quality During the Day
Description	Vision quality during the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Vision quality during the day was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Delefilcon A	Lotrafilcon B	Nelfilcon A	Narafilcon A
Arm/Group Description	Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Measure Participants	40	23	26	28
Mean (Standard Deviation) [Units on a scale]	9.6 (0.6)	8.8 (1.2)	9.5 (0.9)	8.7 (1.3)

3. Primary Outcome

Title	Overall Handling
Description	Overall handling was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall handling was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Delefilcon A	Lotrafilcon B	Nelfilcon A	Narafilcon A
Arm/Group Description	Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Measure Participants	40	23	26	28
Mean (Standard Deviation) [Units on a scale]	9.3 (0.9)	8.5 (1.4)	9.3 (0.9)	9.1 (1.3)

4. Primary Outcome

Title	Dryness Throughout the Day
Description	Dryness throughout the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Dryness throughout the day was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Delefilcon A	Lotrafilcon B	Nelfilcon A	Narafilcon A
Arm/Group Description	Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Measure Participants	40	23	26	28
Mean (Standard Deviation) [Units on a scale]	9.5 (0.6)	7.7 (2.0)	9.0 (1.5)	8.5 (1.5)

5. Primary Outcome

Title	Average Daily Wear Time
Description	Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Delefilcon A	Lotrafilcon B	Nelfilcon A	Narafilcon A
Arm/Group Description	Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Measure Participants	40	23	26	28
Mean (Standard Deviation) [Hours]	13.8 (2.2)	13.8 (2.1)	14.2 (1.8)	13.8 (1.6)

6. Secondary Outcome

Title	Lens Fit
Description	Lens fit was assessed by the investigator for each eye using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptable loose, 1=acceptable loose, 0=optimal, -1=acceptable tight, and -2=unacceptable tight.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Delefilcon A	Lotrafilcon B	Nelfilcon A	Narafilcon A
Arm/Group Description	Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Measure Participants	40	23	26	28
Measure Eyes	80	46	52	56
Mean (Standard Deviation) [Units on a scale]	0.1 (0.3)	0.1 (0.6)	0.1 (0.6)	-0.6 (0.7)

7. Secondary Outcome

Title	Corrected Visual Acuity
Description	Corrected visual acuity was tested for each eye while the participant read distant charts in normal lighting. Corrected visual acuity was measured with a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Delefilcon A	Lotrafilcon B	Nelfilcon A	Narafilcon A
Arm/Group Description	Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Measure Participants	40	23	26	28
Measure Eyes	80	46	52	56
Mean (Standard Deviation) [logMAR]	-0.06 (0.04)	-0.04 (0.06)	-0.07 (0.05)	-0.06 (0.06)

8. Secondary Outcome

Title	Overall Satisfaction
Description	Overall satisfaction was recorded on a 5-point Likert scale as a single, retrospective evaluation of 4 weeks of wear. The following scale was used: 2=very satisfied, 1=somewhat satisfied, 0=neither, -1=somewhat dissatisfied, and -2=very dissatisfied.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Delefilcon A	Lotrafilcon B	Nelfilcon A	Narafilcon A
Arm/Group Description	Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Measure Participants	40	23	26	28
Mean (Standard Deviation) [Units on a scale]	1.4 (1.3)	0.6 (1.4)	1.5 (0.8)	1.1 (1.0)

Adverse Events

Time Frame	Adverse events were collected for the duration of the trial: 15-NOV-2010 to 20-DEC-2010.
Adverse Event Reporting Description	The safety population included all enrolled and exposed participants: 129.
Arm/Group Title	Delefilcon A		Lotrafilcon B		Nelfilcon A		Narafilcon A
Arm/Group Description	Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.		Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.		Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.		Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
All Cause Mortality
	Delefilcon A		Lotrafilcon B		Nelfilcon A		Narafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Delefilcon A		Lotrafilcon B		Nelfilcon A		Narafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/29 (0%)		0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Delefilcon A		Lotrafilcon B		Nelfilcon A		Narafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		5/29 (17.2%)		2/30 (6.7%)		2/30 (6.7%)
Eye disorders
Contact Lens-Related Discomfort	0/40 (0%)		5/29 (17.2%)		0/30 (0%)		0/30 (0%)
Contact Lens-Related Dryness	0/40 (0%)		0/29 (0%)		2/30 (6.7%)		0/30 (0%)
Contact Lens-Related Unacceptable Subjective Vision	0/40 (0%)		0/29 (0%)		0/30 (0%)		2/30 (6.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.