Complete Easy Rub Comparative Efficacy Study

Not Applicable

Withdrawn

• Conditions: Myopia; Hyperopia; Astigmatism
• Interventions: Device: Complete Easy Rub Formula MPS; Device: Aquify MPS

• Registration Number: NCT01019564
• Lead Sponsor: Abbott Medical Optics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-20
• Study First Submitted QC: 2009-11-24
• Study First Posted: 2009-11-25
• Study Start: 2009-12
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Easy Rub MPS	Complete Easy Rub Formula MPS	Complete Easy Rub Formula MPS
Aquify MPS	Aquify MPS	-

Primary Outcome Measures

Name	Time	Method
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