Clinical Evaluation of the Causes of Contact Lens Related Dry Eye

Alcon

Status: Completed

Conditions: Contact Lens Related Dry Eye

Treatments: Device: ReNu MultiPlus; Device: Opti-Free RepleniSH; Device: Contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT00995189

M-09-03 / DRYS 1302 / IBIS

Details and patient eligibility

About

The purpose of this study was to clinically evaluate the potential causes of contact lens-related dry eye.

Full 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.

Enrollment: 159 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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159 participants in 2 patient groups

OFR

Experimental group

Description:

Opti-Free RepleniSH contact lens care solution used for 30 days

Treatment:

Device: Opti-Free RepleniSH

Device: Contact lenses

RNM

Active Comparator group

Description:

ReNu MultiPlus contact lens care solution used for 30 days

Treatment:

Device: ReNu MultiPlus

Device: Contact lenses