Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01035905
• Collaborator: (none)
• Enrollment: 63
• Arms: 2
• Duration (Months): 3

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of two different daily disposable contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Nelfilcon A contact lens; Device: Narafilcon A contact lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Nov 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nelfilcon A Nelfilcon A contact lens	Device: Nelfilcon A contact lens; Daily disposable contact lens worn in a daily wear, daily disposable mode
Active Comparator: Narafilcon A Narafilcon A contact lens	Device: Narafilcon A contact lens; Daily disposable contact lens worn in a daily wear, daily disposable mode

Outcome Measures

Primary Outcome Measures

1. Lens Awareness [4 weeks of wear]

   Lens awareness, as interpreted by the subject and reported by the subject in a questionnaire as a single, retrospective evaluation of 4-week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Currently wear daily disposable, spherical, soft lens wearers (except the two study products) for at least the past 6 months.

• Habitually wear lenses for at least 8 hours per day and 4 days per week.

• Report 2 or more qualifying symptoms with current contact lenses.

• Able to achieve visual acuity of at least 20/40 in each eye with habitual and with study lenses at dispense.

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

Exclusion Criteria:

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

• Currently enrolled in any clinical trial.

• Any use of ocular medications, exclusive of contact lens rewetting drops.

• History of corneal or refractive surgery.

• Cylinder correction greater than 1.00 D

• Current monovision contact lens wearers.

• Other protocol-defined inclusion/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: NCT01035905
• Other Study ID Numbers: P-337-C-030
• First Posted: Dec 21, 2009
• Last Update Posted: Jul 10, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Nelfilcon A	Narafilcon A
Arm/Group Description	Nelfilcon A contact lens	Narafilcon A contact lens
Period Title: Overall Study
STARTED	32	31
COMPLETED	31	30
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Nelfilcon A	Narafilcon A	Total
Arm/Group Description	Nelfilcon A contact lens	Narafilcon A contact lens	Total of all reporting groups
Overall Participants	32	31	63
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.7 (8.4)	35.7 (11.9)	33.7 (10.4)
Sex: Female, Male (Count of Participants)
Female	17 53.1%	24 77.4%	41 65.1%
Male	15 46.9%	7 22.6%	22 34.9%

Outcome Measures

1. Primary Outcome

Title	Lens Awareness
Description	Lens awareness, as interpreted by the subject and reported by the subject in a questionnaire as a single, retrospective evaluation of 4-week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement.
Time Frame	4 weeks of wear

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	Nelfilcon A	Narafilcon A
Arm/Group Description	Nelfilcon A contact lens	Narafilcon A contact lens
Measure Participants	31	30
Number [Participants]	8 25%	9 29%

Adverse Events

Time Frame	63 days, duration of the study
Adverse Event Reporting Description	4 weeks of exposure to product
Arm/Group Title	Nelfilcon A		Narafilcon A
Arm/Group Description	Nelfilcon A contact lens		Narafilcon A contact lens
All Cause Mortality
	Nelfilcon A		Narafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Nelfilcon A		Narafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Nelfilcon A		Narafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/31 (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.