Clinical Evaluation of the Causes of Contact Lens Related Dry Eye

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT00995189

First received: October 14, 2009

Last updated: October 19, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	October 14, 2009
Last Updated Date	October 19, 2012
Start Date ^ICMJE	August 2009
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 14, 2009)	Subjective Dryness [ Time Frame: 2 weeks, one month ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00995189 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 14, 2009)	corneal staining [ Time Frame: 2 weeks, one month ] [ Designated as safety issue: Yes ] conjunctival staining [ Time Frame: two weeks, one month ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical Evaluation of the Causes of Contact Lens Related Dry Eye
Official Title ^ICMJE	A Clinical Evaluation of the Causes of Soft Contact Lens Related Dry Eye
Brief Summary	The purpose of this study was to clinically evaluate the potential causes of contact lens-related dry eye.
Detailed Description	Daily wear soft contact lens wearers reporting significant contact lens-related dryness symptoms were enrolled. Late day dryness with contact lenses, intensity grade 3-5, frequency "sometimes / frequently / constantly" as evaluated by a questionnaire was considered significant.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care
Condition ^ICMJE	Contact Lens Related Dry Eye
Intervention ^ICMJE	Device: Opti-Free RepleniSH Contact lens care solution containing polyquaternium-1 (PQT) Device: ReNu MultiPlus Contact lens care solution containing polyhexamethylene biguanide (PHMB) Other Name: ReNu MultiPlus Device: Contact lenses Daily wear, frequent replacement contact lenses per participant's habitual brand and power.
Study Arm (s)	Experimental: OFR Opti-Free RepleniSH contact lens care solution used for 30 days Interventions: Device: Opti-Free RepleniSH Device: Contact lenses Active Comparator: RNM ReNu MultiPlus contact lens care solution used for 30 days Interventions: Device: ReNu MultiPlus Device: Contact lenses
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	159
Completion Date	April 2010
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Reports late-day dryness symptoms with contact lens wear on questionnaire. Wears FDA Group 2 hydrogel, FDA Group 4 hydrogel, or silicone hydrogel lenses. Consistently uses either polyhexamethylene biguanide (PHMB) or polyquaternium-1 (PQT) contact lens care products (i.e. >6 months including 1 month immediately before enrollment). Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Wears daily disposable contact lenses. Has significant symptoms related to lens fit or lens deposits. Requires concurrent ocular medication (rewetting drops allowed). Has used Restasis® in the last 3 months. Wears punctal plugs fitted in the last 30 days. Has any current systemic or ocular abnormality, infection or disease. Uses any current systemic medication likely to affect tear film, e.g. antihistamines, betaadrenergic blockers, steroids. Has a history of refractive surgery. Other protocol-defined exclusion criteria may apply.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00995189
Other Study ID Numbers ^ICMJE	M-09-03 / DRYS 1302 / IBIS
Has Data Monitoring Committee	No
Responsible Party	Alcon Research
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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