Clinical Evaluation of Two Daily Disposable Lenses in a Population of Daily Disposable (DD) Lens Wearers

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00958828
• Collaborator: (none)
• Enrollment: 178
• Arms: 2
• Duration (Months): 2

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the performance of two daily disposable contact lenses in a population of daily disposable contact lens wearers.

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: 178 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Two Daily Disposable Lenses in a Population of Daily Disposable (DD) Lens Wearers
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: Nelfilcon A / Narafilcon A Nelfilcon A contact lenses, then Narafilcon A contact lenses	Device: Nelfilcon A contact lens; Spherical, soft contact lens for daily disposable wear; Device: Narafilcon A contact lens; Spherical, soft contact lens for daily disposable wear
Other: Narafilcon A / Nelfilcon A Narafilcon A contact lenses, then Nelfilcon A contact lenses	Device: Nelfilcon A contact lens; Spherical, soft contact lens for daily disposable wear; Device: Narafilcon A contact lens; Spherical, soft contact lens for daily disposable wear

Outcome Measures

Primary Outcome Measures

1. Overall Lens Satisfaction [After 1 week of wear]

   Overall Lens Satisfaction, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall lens satisfaction was measured 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:

• Currently wearing any spherical daily disposable contact lens except the two study products for at least 3 months prior to enrollment.

• Currently wearing contact lenses at least 8 hours/day and 5 days/week.

• Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria:

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

• Currently enrolled in any clinical trial.

• Prior history of corneal or refractive surgery.

• Monovision correction.

• Other protocol 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: NCT00958828
• Other Study ID Numbers: P-337-C-028
• First Posted: Aug 13, 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	Narafilcon A / Nelfilcon A
Arm/Group Description	Nelfilcon A contact lenses, then Narafilcon A contact lenses	Narafilcon A contact lenses, then Nelfilcon A contact lenses
Period Title: Period 1, 1 Week of Wear
STARTED	89	89
COMPLETED	89	88
NOT COMPLETED	0	1
Period Title: Period 1, 1 Week of Wear
STARTED	89	88
COMPLETED	89	87
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	This reporting group includes all enrolled and dispensed subjects.
Overall Participants	178
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.0 (12.1)
Sex: Female, Male (Count of Participants)
Female	111 62.4%
Male	67 37.6%

Outcome Measures

1. Primary Outcome

Title	Overall Lens Satisfaction
Description	Overall Lens Satisfaction, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	After 1 week of wear

Outcome Measure Data

Analysis Population Description

Per protocol

Arm/Group Title	Nelfilcon A Contact Lens	Narafilcon A Contact Lens
Arm/Group Description	Spherical, soft contact lens for daily disposable wear	Spherical, soft contact lens for daily disposable wear
Measure Participants	174	175
Mean (Standard Deviation) [Units on a scale]	7.5 (2.2)	7.5 (2.3)

Adverse Events

Time Frame	39 days, duration of the trial
Arm/Group Title	Nelfilcon A Contact Lens		Narafilcon A Contact Lens
Arm/Group Description	Spherical, soft contact lens for daily disposable wear		Spherical, soft contact lens for daily disposable wear
All Cause Mortality
	Nelfilcon A Contact Lens		Narafilcon A Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Nelfilcon A Contact Lens		Narafilcon A Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/177 (0%)		0/178 (0%)
Other (Not Including Serious) Adverse Events
	Nelfilcon A Contact Lens		Narafilcon A Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/177 (0%)		0/178 (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.