Complete Easy Rub Comparative Efficacy Study

The aim of this trial is to assess Complete Easy Rub compared to a competitor multi-purpose solution in terms of lens cleanliness, subjective response and ocular response, when lenses are worn bilaterally on a daily wear basis for two months.

The hypotheses for this trial are:

• Lens cleanliness measures between solutions will be no different.
• Subjective ratings between solutions will be no different.
• Ocular response between solutions will be no different.

Study Overview

• Status: Withdrawn
• Conditions: Astigmatism; Myopia; Hyperopia
• Intervention / Treatment: Device: Complete Easy Rub Formula MPS; Device: Aquify MPS

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
• Be at least 18 years old, male or female;
• Willing to comply with the wearing and clinical trial visit schedule as directed by the investigator;
• Have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses;
• Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
• Able to successfully wear one of the lens types to be used in this study on a daily wear (DW) basis in conjunction with any multi-purpose contact lens care solution (not including hydrogen peroxide-based systems) for at least one month prior to allocation of test or control solution;

Exclusion Criteria:

• Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses;
• Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants;
• Use of, or a need for, concurrent category S3 and above ocular medication at enrolment and/or during the study;
• Use of, or a need for, any systemic medication or topical medications which may alter normal ocular findings/are known to affect a participant's ocular health/physiology or contact lens performance either in an adverse manner or beneficial manner at enrolment and/or during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Easy Rub MPS; Complete Easy Rub Formula MPS	Device: Complete Easy Rub Formula MPS; Multi-purpose solution
Active Comparator: Aquify MPS	Device: Aquify MPS; Multi-purpose solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of lens cleanliness of test and control solutions when used with soft lenses at the end of the manufacturer-recommended replacement interval.	Day 30

Collaborators and Investigators

• Sponsor: Abbott Medical Optics

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Anticipated): March 1, 2010
• Study Completion (Anticipated): March 1, 2010

Study Registration Dates

• First Submitted: November 20, 2009
• First Submitted That Met QC Criteria: November 24, 2009
• First Posted (Estimate): November 25, 2009

Study Record Updates

• Last Update Posted (Actual): June 28, 2017
• Last Update Submitted That Met QC Criteria: June 26, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism; Hyperopia
• Other Study ID Numbers: COMP-319-9424