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Clinical Evaluation of the Causes of Contact Lens Related Dry Eye

NCT ID: NCT00995189

Last Updated: 2016-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Contact Lens Related Dry Eye

Keywords

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contact lens wear multi-purpose solution corneal staining

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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OFR

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

Group Type EXPERIMENTAL

Opti-Free RepleniSH

Intervention Type DEVICE

Contact lens care solution containing polyquaternium-1 (PQT)

Contact lenses

Intervention Type DEVICE

Daily wear, frequent replacement contact lenses per participant's habitual brand and power.

RNM

ReNu MultiPlus contact lens care solution used for 30 days

Group Type ACTIVE_COMPARATOR

ReNu MultiPlus

Intervention Type DEVICE

Contact lens care solution containing polyhexamethylene biguanide (PHMB)

Contact lenses

Intervention Type DEVICE

Daily wear, frequent replacement contact lenses per participant's habitual brand and power.

Interventions

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Opti-Free RepleniSH

Contact lens care solution containing polyquaternium-1 (PQT)

Intervention Type DEVICE

ReNu MultiPlus

Contact lens care solution containing polyhexamethylene biguanide (PHMB)

Intervention Type DEVICE

Contact lenses

Daily wear, frequent replacement contact lenses per participant's habitual brand and power.

Intervention Type DEVICE

Eligibility Criteria

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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).

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

References

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Chalmers RL, Young G, Kern J, Napier L, Hunt C. Soft Contact Lens-Related Symptoms in North America and the United Kingdom. Optom Vis Sci. 2016 Aug;93(8):836-47. doi: 10.1097/OPX.0000000000000927.

Reference Type RESULT
PMID: 27391535 (View on PubMed)

Other Identifiers

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M-09-03 / DRYS 1302 / IBIS

Identifier Type: -

Identifier Source: org_study_id