Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01362907
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Duration (Months): 1

Study Details

Study Description

Brief Summary

The purpose of this trial was to compare the performance of an investigational daily disposable contact lens to a commercially available daily disposable contact lens.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Delefilcon A contact lens; Device: Etafilcon A contact lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: Delefilcon A / etafilcon A Delefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.	Device: Delefilcon A contact lens; Investigational, silicone hydrogel, single vision, soft contact lens for daily disposable wear; Other Names: DAILIES® Total1® ; Device: Etafilcon A contact lens; Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear; Other Names: 1-DAY ACUVUE® MOIST™
Other: Etafilcon A / delefilcon A Etafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.	Device: Delefilcon A contact lens; Investigational, silicone hydrogel, single vision, soft contact lens for daily disposable wear; Other Names: DAILIES® Total1® ; Device: Etafilcon A contact lens; Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear; Other Names: 1-DAY ACUVUE® MOIST™

Outcome Measures

Primary Outcome Measures

1. Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA) [1 week of wear, replacing lenses daily]

   As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity.

2. Overall Comfort [1 week of wear, 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 evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

3. Overall Vision Quality [1 week of wear, 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 quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

4. Overall Handling [1 week of wear, 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 evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy.

Secondary Outcome Measures

1. Overall Lens Fit [1 week of wear, replacing lenses daily]

   As assessed for each eye individually by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit is reported 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: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Normal eyes with no use of ocular medications.

• Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.

• Willing and able to wear spherical contact lenses for protocol-specified timeframe within the available range of powers (-1.00 D to -6.00D in 0.25D steps).

• Visual acuity with study lenses 20/25 or better.

• Cylinder less than or equal to 0.75 D.

• Currently wearing daily disposable lenses.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Anterior segment infection, inflammation, or abnormality.

• Any active anterior segment ocular disease that would contraindicate contact lens wear.

• Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator.

• History of refractive surgery or irregular cornea.

• Eye injury within twelve weeks immediately prior to enrollment for this trial.

• Currently enrolled in any clinical trial.

• 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: NCT01362907
• Other Study ID Numbers: P-347-C-013
• First Posted: Jun 1, 2011
• Last Update Posted: Aug 3, 2012
• Last Verified: Jun 1, 2012

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 4 US private practices.

Arm/Group Title	Delefilcon A / Etafilcon A	Etafilcon A / Delefilcon A
Arm/Group Description	Delefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.	Etafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Period Title: Period 1, One Week
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0
Period Title: Period 1, One Week
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	All enrolled participants
Overall Participants	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.7 (9.5)
Sex: Female, Male (Count of Participants)
Female	29 72.5%
Male	11 27.5%
Region of Enrollment (participants) [Number]
United States	40 100%

Outcome Measures

1. Primary Outcome

Title	Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)
Description	As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity.
Time Frame	1 week of wear, replacing lenses daily

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed participants.

Arm/Group Title	Delefilcon A	Etafilcon A
Arm/Group Description	Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.	Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Measure Participants	40	40
Measure eyes	80	80
Mean (Standard Deviation) [logMAR]	-0.02 (0.06)	-0.02 (0.05)

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 evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	1 week of wear, replacing lenses daily

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed participants.

Arm/Group Title	Delefilcon A	Etafilcon A
Arm/Group Description	Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.	Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Measure Participants	40	40
Mean (Standard Deviation) [Units on a scale]	9.0 (1.5)	8.1 (1.6)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed participants.

Arm/Group Title	Delefilcon A	Etafilcon A
Arm/Group Description	Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.	Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Measure Participants	40	40
Mean (Standard Deviation) [Units on a scale]	9.4 (1.0)	8.9 (1.2)

4. 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 evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy.
Time Frame	1 week of wear, replacing lenses daily

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed participants.

Arm/Group Title	Delefilcon A	Etafilcon A
Arm/Group Description	Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.	Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Measure Participants	40	40
Mean (Standard Deviation) [Units on a scale]	8.5 (1.9)	8.6 (1.4)

5. Secondary Outcome

Title	Overall Lens Fit
Description	As assessed for each eye individually by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit is reported on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight.
Time Frame	1 week of wear, replacing lenses daily

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed participants.

Arm/Group Title	Delefilcon A	Etafilcon A
Arm/Group Description	Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.	Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Measure Participants	40	40
Measure eyes	80	80
Mean (Standard Deviation) [Units on a scale]	-0.1 (0.5)	0.1 (0.3)

Adverse Events

Time Frame	Adverse events were collected for the duration of the trial: 1 month.
Adverse Event Reporting Description	The safely population included all enrolled and exposed participants.
Arm/Group Title	Delefilcon A		Etafilcon A
Arm/Group Description	Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.		Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
All Cause Mortality
	Delefilcon A		Etafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Delefilcon A		Etafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Delefilcon A		Etafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (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.