Masked Comparison of a New PEG Based Artificial Tear and Optive for Comfort, Vision & Wear Time in Patients Wearing Contact Lenses

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

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-02-28

Brief Summary

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The objective of this study is to evaluate the effect of a new PEG based artificial tear as compared to Optive on comfort, wear time, and vision in patients wearing contact lenses.

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Detailed Description

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Conditions

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Comfort, Vision and Wear Time

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1.

Group Type ACTIVE_COMPARATOR

New PEG based artificial tear

Intervention Type DRUG

1, 2, (in the eye) Instill one drop in the left eye or right eye four times daily (can be used more frequently if needed)

2.

Group Type PLACEBO_COMPARATOR

Optive

Intervention Type DRUG

1, 2, (in the eye) Instill one drop in the left eye or right eye four times daily (can be used more frequently if needed)

Interventions

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New PEG based artificial tear

1, 2, (in the eye) Instill one drop in the left eye or right eye four times daily (can be used more frequently if needed)

Intervention Type DRUG

Optive

1, 2, (in the eye) Instill one drop in the left eye or right eye four times daily (can be used more frequently if needed)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Use of soft contact lenses (e.g. silicone hydrogel lenses, daily disposables etc.) and multipurpose solution for cleaning, including enzyme-based cleaners (ClearCare etc.)
* Able to wear contact lenses for approximately 10-12 hours/day
* Willingness to complete entire length of trial and comply with subjective questionnaire.

Exclusion Criteria

* Patients taking topical cyclosporine (Restasis)
* Patients currently using Optive for dryness relief.
* Patients wearing hard or rigid gas permeable lenses
* Patients with uncontrolled systemic disease which may confound the results of the trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes