Evaluation of tear lipid changes during daily wear of silicone hydrogel lenses and use of two lens disinfection solutions in 30 new and experienced contact lens wearing participants.

Not Applicable

Completed

• Conditions: Contact Lens Wear; Eye - Normal eye development and function

• Registration Number: ACTRN12608000609358
• Lead Sponsor: Institute for Eye Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-12-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Participants enrolled in the trial must:
Be 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;
Be 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;
Have vision correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
Be experienced or may be inexperienced at wearing contact lenses.

Exclusion Criteria

Participants enrolled in the trial must NOT have:
Pre-existing ocular irritation that would preclude contact lens fitting;
Known allergies to any of the ingredients in products tested;
An ocular condition that may preclude safe wearing of contact lenses;
An active corneal infection or any active ocular disease that would affect wearing of contact lenses;
A need for concurrent category S3 and above ocular medication up to 12 weeks prior to and during the trial;
Any systemic disease where fasting is contraindicated e.g. Type 1 diabetes, hypoglycaemia and any blood disorders (e.g. haemophilia)
Any systemic disease that may affect ocular health. Conditions such as systemic hypertension do not automatically exclude prospective participants;
Any systemic or topical medications up to 12 weeks prior to and during the trial that will affect ocular physiology or the performance of the lenses;
Had eye surgery within 12 weeks immediately prior to enrolment for this trial;
Undergone corneal refractive surgery;
Any ocular injury or condition (including keratoconus, herpes keratitis and orthokeratology) of the cornea, conjunctiva or eyelids that would affect the wearing of contact lenses;
Contraindications to contact lens wear;
Currently enrolled in another clinical trial or participated in contact lens clinical trial within 2 weeks;
Worn contact lenses for the past 2 weeks;
Be pregnant.
The Investigator may, at his/her discretion, exclude anyone else 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

Primary Outcome Measures

Name	Time	Method
To investigate tear film lipid changes after contact lens wear. To do this we will be collecting tears at every visit and assessing tear lipid levels using mass spectrometery.[Assessments will occur on a fortnightly basis]

Secondary Outcome Measures

Name	Time	Method
To correlate tear lipid changes after contact lens wear with lens performance. We will be collecting tears at every visit and assessing lipid levels. We will also be giving participants questionnaires at every visit, and assessing lens fit, vision and ocular health (i.e. redness, corneal staining) at every visit.[Assessments will occur on a fortnightly basis]