Prospective Study of an Investigational Daily Disposable Contact Lens

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01295905
• Collaborator: (none)
• Enrollment: 90
• Arms: 2
• Duration (Months): 3.9

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the performance of an investigational daily disposable contact lens.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: delefilcon A contact lens; Device: narafilcon B contact lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: delefilcon A Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.	Device: delefilcon A contact lens; Investigational silicone hydrogel, single vision soft contact lens
Active Comparator: narafilcon B Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.	Device: narafilcon B contact lens; Commercially marketed silicone hydrogel, single vision soft contact lens

Outcome Measures

Primary Outcome Measures

1. Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity [3 months of wear, lenses replaced daily]

   Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better.

Secondary Outcome Measures

1. Overall Vision [3 months of wear, lenses replaced daily]

   As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

2. Overall Comfort [3 months of wear, lenses replaced daily]

   As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months 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 Handling [3 months of wear, lenses replaced daily]

   As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Subjects with normal eyes who are not using any 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 at least 5 days per week.

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

• Best spectacle-corrected visual acuity greater than or equal to 20/25.

• Manifest cylinder less than or equal to 0.75D.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• 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.

• History of pathologically dry eye.

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

• Currently enrolled in any clinical trial.

• Participation in a contact lens or contact lens care product clinical trial within the previous 30 days.

• 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: NCT01295905
• Other Study ID Numbers: P-347-C-004
• First Posted: Feb 15, 2011
• Last Update Posted: Jul 10, 2012
• Last Verified: May 1, 2012

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	Participants were recruited and enrolled from six (6) US study centers.
Pre-assignment Detail	This reporting group includes all enrolled participants.

Arm/Group Title	Delefilcon A	Narafilcon B
Arm/Group Description	Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.	Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
Period Title: Overall Study
STARTED	60	30
COMPLETED	58	30
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Delefilcon A	Narafilcon B	Total
Arm/Group Description	Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.	Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.	Total of all reporting groups
Overall Participants	60	30	90
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.01 (8.86)	31.39 (10.05)	29.80 (9.29)
Sex: Female, Male (Count of Participants)
Female	40 66.7%	19 63.3%	59 65.6%
Male	20 33.3%	11 36.7%	31 34.4%
Region of Enrollment (participants) [Number]
United States	60 100%	30 100%	90 100%

Outcome Measures

1. Primary Outcome

Title	Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity
Description	Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better.
Time Frame	3 months of wear, lenses replaced daily

Outcome Measure Data

Analysis Population Description

Per protocol.

Arm/Group Title	Delefilcon A	Narafilcon B
Arm/Group Description	Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.	Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
Measure Participants	58	30
Measure eyes	116	60
Number [eyes]	111	58

2. Secondary Outcome

Title	Overall Vision
Description	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	3 months of wear, lenses replaced daily

Outcome Measure Data

Analysis Population Description

Per protocol.

Arm/Group Title	Delefilcon A	Narafilcon B
Arm/Group Description	Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.	Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
Measure Participants	58	30
Mean (Standard Deviation) [Units on a scale]	9.5 (0.8)	9.1 (1.1)

3. Secondary Outcome

Title	Overall Comfort
Description	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months 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	3 months of wear, lenses replaced daily

Outcome Measure Data

Analysis Population Description

Per protocol.

Arm/Group Title	Delefilcon A	Narafilcon B
Arm/Group Description	Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.	Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
Measure Participants	58	30
Mean (Standard Deviation) [Units on a scale]	9.3 (0.9)	8.9 (1.2)

4. Secondary Outcome

Title	Overall Handling
Description	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	3 months of wear, lenses replaced daily

Outcome Measure Data

Analysis Population Description

Per protocol.

Arm/Group Title	Delefilcon A	Narafilcon B
Arm/Group Description	Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.	Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
Measure Participants	58	30
Mean (Standard Deviation) [Units on a scale]	9.1 (1.3)	9.1 (1.2)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study: 19-JAN-2011 to 20-MAY-2011.
Adverse Event Reporting Description	This reporting group includes all enrolled and exposed participants.
Arm/Group Title	Delefilcon A		Narafilcon B
Arm/Group Description	Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.		Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
All Cause Mortality
	Delefilcon A		Narafilcon B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Delefilcon A		Narafilcon B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		1/30 (3.3%)
Eye disorders
Sterile infiltrate with secondary iritis	0/60 (0%)		1/30 (3.3%)
Other (Not Including Serious) Adverse Events
	Delefilcon A		Narafilcon B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/30 (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.