A prospective, open-label, daily wear, parallel group, randomised clinical trial assessing an investigational contact lens care solution for comfort, safety and efficacy with four commercially available contact lenses, worn bilaterally over three months, in both experienced and new contact lens wearers

Phase 3

Completed

• Conditions: Contact lens wear; Contact lens care solution; Eye - Normal eye development and function

• Registration Number: ACTRN12609000640202
• Lead Sponsor: Abbott Medical Optics, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

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;
-May be experienced or inexperienced at wearing contact lenses

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, Sjogrens 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;
N.B. Systemic antihistamines are allowed on an ‘as needed basis’, provided they are not used -prophylactically during the trial
-Eye surgery within 12 weeks immediately prior to enrolment for this trial;
-Previous corneal refractive surgery;
-Contraindications to contact lens wear;
-Known allergy or intolerance to ingredients in any of the study products;
-Currently enrolled in another clinical trial;
-Participation in a clinical trial within the previous 2 weeks for dispensing studies and 48 hours -between in-house studies;
Pregnancy*;

The Investigator may, at his/her discretion, exclude anyone who they believe may not be able to fulfil the study requirements, or if it is believed to be in the participant’s best interests.

*Formal testing of pregnancy is not required. A participant’s verbal report is sufficient

Study & Design

• Study Type: Interventional
• Study Design: Not specified