Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00813982

Purpose

The objectives of the trial are to compare subjective ratings and preferences between lotrafilcon A enhanced lenses and commercial lotrafilcon A lenses. Lens fit and lens surface characteristics will also be assessed.

Condition	Intervention	Phase
Myopia	Device: lotrafilcon A	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind (Subject)
Official Title:	Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses.

Further study details as provided by Novartis:

Primary Outcome Measures:

Ratings for comfort, dryness, ease of insertion, overall handling and overall vision, as well as the following preferences: comfort after insertion, overall comfort, overall handling and overall lens preference. [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

lens surface characteristics [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Enrollment:	58
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
1 lotrafilcon A upgrade contact lenses: Experimental contact lenses	Device: lotrafilcon A
2 lotrafilcon A commercial contact lenses: Active Comparator contact lenses	Device: lotrafilcon A

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Lens wearer who are able to wear their lenses for a minimum of 5 days a week, at least 8 hours a day
On exam have ocular findings considered to be normal and which would not prevent a subject from safely wearing contact lenses
Able to wear lenses in the powers available

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
Any active corneal infection
Any use of medications for which contact lens wear would be contraindicated
History of corneal refractive surgery
Toric contact lens wearers
No more than 20% of total subject population in NIGHT & DAY® lenses habitually Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813982

Locations

United States, California
Jeffrey A. Hall, OD, PC
San Diego, California, United States, 92119
David Wakabayashi
Irvine, California, United States, 92620
United States, Minnesota
Wal-Mart Vision Center
Shakopee, Minnesota, United States, 55379
United States, Pennsylvania
Dombroski Eye Associates
Lancaster, Pennsylvania, United States, 17601
United States, Virginia
Dr. James V. Cornetta
Portsmouth, Virginia, United States, 23704

Sponsors and Collaborators

Novartis

More Information

Responsible Party:	( Novartis: CIBA VISION )
Study ID Numbers:	P-335-C-009
Study First Received:	December 22, 2008
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00813982
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 13, 2009