Complete Easy Rub Comparative Efficacy Study

Abbott

Status

Withdrawn

Conditions

Myopia

Astigmatism

Hyperopia

Treatments

Device: Complete Easy Rub Formula MPS

Device: Aquify MPS

Study type

Interventional

Funder types

Industry

Identifiers

NCT01019564

COMP-319-9424

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

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