Non-Dispense Comfort Comparison of Two Silicone Hydrogel Lenses. - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00808834

Purpose

In an effort to improve the comfort of lotrafilcon A the trial aims to obtain subjective responses related to comfort and handling, and lens surface variables during 15 minutes wear of lotrafilcon A upgrade lenses, and to compare these to responses from senofilconA lens wear.

Condition	Intervention	Phase
Myopia	Device: lotrafilcon A Device: senofilcon A	Phase IV

Drug Information available for: Senofilcon A

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Investigator), Crossover Assignment
Official Title:	Non-Dispense Comfort Comparison of Two Silicone Hydrogel Lenses.

Further study details as provided by Novartis:

Primary Outcome Measures:

Measure: The trial objective is to obtain subjective responses related to comfort and handling, and lens surface variables during 15 minutes wear of lotrafilcon A upgrade lenses, and to compare these to responses from senofilcon A lens wear. [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Ease of removal and lens surface characteristics [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

Enrollment:	200
Study Start Date:	November 2008
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
senofilcon A contact lens: Active Comparator daily wear and extended wear for up to 6 consecutive nights contact lens	Device: senofilcon A FDA approved contact lens for daily wear and extended wear for up to 6 consecutive nights
lotrafilcon A contact lens: Experimental sphere lenses with the addition of copolymer 845	Device: lotrafilcon A To obtain subjective responses related to comfort and handling, and lens surface variables during 15 minutes wear of lotrafilcon A upgrade lenses, and to compare these to responses from ACUVUE® OASYSTM lens wear.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Current soft contact lens wearer
Replace lenses on a weekly or longer schedule

Exclusion Criteria:

Requires concurrent ocular medication
Eye injury or surgery within twelve weeks immediately prior to enrollment
Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions
Current soft toric lens wearers
Those who dispose of their soft lenses on a daily basis
Current NIGHT & DAY® or ACUVUE® OASYS lens wearers
Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808834

Locations

United States, Texas
Eyeland
Conroe, Texas, United States, 77304

Sponsors and Collaborators

Novartis

More Information

Responsible Party:	( Novartis CIBA VISION )
Study ID Numbers:	P-335-C-008
Study First Received:	December 11, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00808834
Health Authority:	United States: Institutional Review Board

Keywords provided by Novartis:

myopia

Study placed in the following topic categories:

Eye Diseases
Myopia
Refractive Errors

ClinicalTrials.gov processed this record on January 14, 2009