Complete Easy Rub Comparative Efficacy Study

NCT01019564 | Withdrawn

• 1 other identifier: COMP-319-9424
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myopia; Hyperopia; Astigmatism

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Easy Rub MPS

EXPERIMENTAL

Complete Easy Rub Formula MPS

Device: Complete Easy Rub Formula MPS

Aquify MPS

ACTIVE COMPARATOR

Device: Aquify MPS

Interventions

Complete Easy Rub Formula MPS DEVICE

Multi-purpose solution

Easy Rub MPS

Aquify MPS DEVICE

Multi-purpose solution

Aquify MPS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Optics: lead

MeSH Terms

Conditions

Myopia; Hyperopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2009
• First Posted: November 25, 2009
• Study Start: December 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 3, 2025

Record last verified: 2025-01