Clinical Evaluation of the Causes of Contact Lens Related Dry Eye

Not Applicable

Completed

• Conditions: Contact Lens Related Dry Eye
• Interventions: Device: Opti-Free RepleniSH; Device: ReNu MultiPlus; Device: Contact lenses

• Registration Number: NCT00995189
• Lead Sponsor: Alcon Research

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-10-14
• Study First Submitted QC: 2009-10-14
• Study First Posted: 2009-10-15
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2012-03
• Last Update Submitted: 2016-11-15
• Last Update Posted: 2016-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OFR	Opti-Free RepleniSH	Opti-Free RepleniSH contact lens care solution used for 30 days
RNM	ReNu MultiPlus	ReNu MultiPlus contact lens care solution used for 30 days
OFR	Contact lenses	Opti-Free RepleniSH contact lens care solution used for 30 days
RNM	Contact lenses	ReNu MultiPlus contact lens care solution used for 30 days

Primary Outcome Measures

Name	Time	Method
Subjective Dryness	2 weeks, one month

Secondary Outcome Measures

Name	Time	Method
corneal staining	2 weeks, one month
conjunctival staining	two weeks, one month

Trial Locations

Locations (1)

Contact Alcon Call Center For Trial Locations; 🇺🇸 Fort Worth, Texas, United States