Clinical Comparison of Two Daily Disposable Toric Lenses

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01362894
• Collaborator: (none)
• Enrollment: 240
• Arms: 2
• Duration (Months): 3

Study Details

Study Description

Brief Summary

The purpose of this trial was to compare the performance of two contact lenses commercially available for people with astigmatism.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Astigmatism	Device: nelfilcon A contact lens; Device: etafilcon A contact lens	N/A

Detailed Description

This trial compared the performance of two commercialized daily disposable contact lenses in Germany.

Study Design

• Study Type: Interventional
• Actual Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Comparison of Two Daily Disposable Toric Lenses
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: nelfilcon A / etafilcon A Nelfilcon A lenses worn first, with etafilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.	Device: nelfilcon A contact lens; Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear.; Other Names: Focus® DAILIES® Toric ; Device: etafilcon A contact lens; Commercially marketed, etafilcon A, toric, soft contact lens for daily disposable wear.; Other Names: 1-DAY ACUVUE® MOIST® FOR ASTIGMATISM
Other: etafilcon A / nelfilcon A Etafilcon A lenses worn first, with nelfilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.	Device: nelfilcon A contact lens; Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear.; Other Names: Focus® DAILIES® Toric ; Device: etafilcon A contact lens; Commercially marketed, etafilcon A, toric, soft contact lens for daily disposable wear.; Other Names: 1-DAY ACUVUE® MOIST® FOR ASTIGMATISM

Outcome Measures

Primary Outcome Measures

1. Overall Vision [1 week, replacing lenses daily]

   As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.

2. Overall Comfort [1 week, replacing lenses daily]

   As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent.

3. Overall Handling [1 week, replacing lenses daily]

   As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy.

4. Overall Satisfaction [1 week, replacing lenses daily]

   As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.

Secondary Outcome Measures

1. Ease of Selecting Final Lens Power [Day 0]

   As interpreted by the investigator at time of lens fitting and recorded on a questionnaire. Ease of selecting final lens power was rated on a 10-point scale, with 1 being difficult and 10 being easy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Sign written informed consent.

• Germany: Be of legal age.

• Current monthly or weekly toric soft lens wearer able to be fit in both eyes with soft toric lenses in the study parameters.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Eye injury or surgery within twelve weeks.

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

• Currently enrolled in an ophthalmic clinical trial.

• Wears contact lenses overnight while sleeping.

• Habitual daily disposable contact lens wearer.

• Monovision correction during the study.

• 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: NCT01362894
• Other Study ID Numbers: P-346-C-013
• First Posted: Jun 1, 2011
• Last Update Posted: Aug 9, 2012
• Last Verified: Jul 1, 2012

• Additional relevant MeSH terms: Astigmatism

Study Results

Participant Flow

Recruitment Details	Participants were recruited and enrolled from 19 German study sites.
Pre-assignment Detail	Two participants were enrolled, but not dispensed, due to unacceptable objective vision (1) and biomicroscopy findings (1). Baseline characteristics are presented on all enrolled and dispensed participants: 238.

Arm/Group Title	Nelfilcon A / Etafilcon A	Etafilcon A / Nelfilcon A
Arm/Group Description	Nelfilcon A lenses worn first, with etafilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.	Etafilcon A lenses worn first, with nelfilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Period Title: Period One, 1 Week
STARTED	119	117
COMPLETED	119	117
NOT COMPLETED	0	0
Period Title: Period One, 1 Week
STARTED	118	115
COMPLETED	118	115
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	All enrolled and dispensed participants.
Overall Participants	238
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.4 (9.7)
Sex: Female, Male (Count of Participants)
Female	159 66.8%
Male	79 33.2%
Region of Enrollment (participants) [Number]
Germany	238 100%

Outcome Measures

1. Primary Outcome

Title	Overall Vision
Description	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	1 week, replacing lenses daily

Outcome Measure Data

Analysis Population Description

The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.

Arm/Group Title	Nelfilcon A	Etafilcon A
Arm/Group Description	Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.	Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Measure Participants	226	228
Mean (Standard Deviation) [Units on a scale]	8.2 (1.7)	7.5 (2.1)

2. Primary Outcome

Title	Overall Comfort
Description	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	1 week, replacing lenses daily

Outcome Measure Data

Analysis Population Description

The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.

Arm/Group Title	Nelfilcon A	Etafilcon A
Arm/Group Description	Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.	Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Measure Participants	227	229
Mean (Standard Deviation) [Units on a scale]	7.8 (1.8)	7.2 (2.0)

3. Primary Outcome

Title	Overall Handling
Description	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy.
Time Frame	1 week, replacing lenses daily

Outcome Measure Data

Analysis Population Description

The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.

Arm/Group Title	Nelfilcon A	Etafilcon A
Arm/Group Description	Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.	Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Measure Participants	227	229
Mean (Standard Deviation) [Units on a scale]	8.2 (1.8)	6.8 (2.2)

4. Primary Outcome

Title	Overall Satisfaction
Description	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	1 week, replacing lenses daily

Outcome Measure Data

Analysis Population Description

The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.

Arm/Group Title	Nelfilcon A	Etafilcon A
Arm/Group Description	Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.	Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Measure Participants	227	229
Mean (Standard Deviation) [Units on a scale]	7.7 (1.9)	6.9 (2.0)

5. Secondary Outcome

Title	Ease of Selecting Final Lens Power
Description	As interpreted by the investigator at time of lens fitting and recorded on a questionnaire. Ease of selecting final lens power was rated on a 10-point scale, with 1 being difficult and 10 being easy.
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.

Arm/Group Title	Nelfilcon A	Etafilcon A
Arm/Group Description	Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.	Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Measure Participants	228	229
Mean (Standard Deviation) [Units on a scale]	8.4 (1.5)	8.8 (1.2)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study: 20-May-2011 to 15-AUG-2011.
Adverse Event Reporting Description	The safety population included all enrolled and dispensed participants.
Arm/Group Title	Nelfilcon A		Etafilcon A
Arm/Group Description	Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.		Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
All Cause Mortality
	Nelfilcon A		Etafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Nelfilcon A		Etafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/234 (0.9%)		0/235 (0%)
Musculoskeletal and connective tissue disorders
Foot injury requiring hospitalization	1/234 (0.4%)	1	0/235 (0%)	0
Surgical and medical procedures
Appendicitis	1/234 (0.4%)	1	0/235 (0%)	0
Other (Not Including Serious) Adverse Events
	Nelfilcon A		Etafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/234 (0%)		0/235 (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.