Complete Easy Rub Comparative Efficacy Study

Myopia Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01019564
• Other study ID #: COMP-319-9424
• Status: Withdrawn
• Phase: N/A
• First received: November 20, 2009
• Last updated: June 26, 2017
• Start date: December 2009
• Est. completion date: March 2010

Study information

• Verified date: June 2017
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Hyperopia
• Myopia

Intervention

Device:
• Complete Easy Rub Formula MPS
Multi-purpose solution
• Aquify MPS
Multi-purpose solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Optics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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