Evaluation of Stenotrophomonas maltophilia case contamination and corneal infiltrative event rates in both experienced and new contact lens wearers.

Completed

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

• Registration Number: ACTRN12610001086055
• Lead Sponsor: Abbott Medical Optics, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

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 infection or disease) 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 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 and at least 24 hours before study product is used;
-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.
-Pregnancy: Formal testing of pregnancy is not required. A participant’s verbal report is sufficient

-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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified