Clinical Evaluation of a Silicone Hydrogel Lens

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research ( CIBA VISION )

ClinicalTrials.gov Identifier:

NCT01016132

First received: November 17, 2009

Last updated: June 26, 2012

Last verified: September 2011

History of Changes

Purpose

The purpose of this study is to assess the performance of an investigational contact lens among contact lens wearers.

Condition	Intervention
Myopia	Device: lotrafilcon A contact lens

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Overall Preference [ Time Frame: 4 weeks of wear ] [ Designated as safety issue: No ]
Overall preference when comparing study lenses to "habitual" lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of four weeks' wear time. Overall preference was measured on a 5-point Likert scale as follows: Strongly Prefer Study Lenses; Somewhat Prefer Study Lenses; No Preference; Somewhat Prefer "Habitual" Lenses; Strongly Prefer "Habitual" Lenses.

Enrollment:	152
Study Start Date:	October 2009
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Investigational silicone hydrogel, single-vision, soft contact lens worn for four weeks at least as often as and on the same basis as participant's habitual lenses, as prescribed by participant's eye care practitioner -- ie., on a daily wear, flex wear, or extended wear basis.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Currently wearing lotrafilcon A lenses in both eyes for a minimum of 5 days per week, 8 hours per day, for 3 months.
Removes contact lenses daily or sleeps overnight in contact lenses (up to 30 consecutive nights) as prescribed by regular eye care practitioner.
Able to achieve distance visual acuity of at least 20/40 in each eye with study lenses.
Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria:

Eye injury or surgery within 12 months prior to enrollment.
Currently enrolled in any clinical trial.
History of corneal refractive surgery.
Other protocol inclusion/exclusion criteria may apply.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:	NCT01016132 History of Changes
Other Study ID Numbers:	P-019-C-055
Study First Received:	November 17, 2009
Results First Received:	December 17, 2010
Last Updated:	June 26, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on June 13, 2013

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