Complete Easy Rub Comparative Efficacy Study

NCT ID: NCT01019564

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Easy Rub MPS

Complete Easy Rub Formula MPS

Group Type: EXPERIMENTAL

Complete Easy Rub Formula MPS

Intervention Type: DEVICE

Multi-purpose solution

Aquify MPS

Group Type: ACTIVE_COMPARATOR

Aquify MPS

Intervention Type: DEVICE

Multi-purpose solution

Interventions

Complete Easy Rub Formula MPS

Multi-purpose solution

Intervention Type: DEVICE

Aquify MPS

Multi-purpose solution

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott Medical Optics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

COMP-319-9424

Identifier Type: -

Identifier Source: org_study_id