A prospective, cross-over, randomised clinical trial to establish the ocular comfort profile with and without lens wear over a 12 hour period and to assess the changes in the profile when lens are inserted at different times of the day and worn for 4 hours, with AIR OPTIX (trademark) AQUA contact lenses

Not Applicable

Completed

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

• Registration Number: ACTRN12609000431224
• Lead Sponsor: CIBA VISIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

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;
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;
Be able to insert and remove contact lenses;
Experienced contact lens wearer;

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 erythematosis. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants;
An active corneal infection or any active ocular disease that would affect wearing of contact lenses;
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 (including systemic antihistamines) 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 risk providing a false positive.
Eye surgery within 12 weeks immediately prior to enrolment for this trial;
Previous corneal refractive surgery;
Contraindications to contact lens wear;
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;

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.

N.B.Whilst pregnant or lactating women are not excluded from the trial, they must be able to complete the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subjective ocular comfort with contact lenses. This will be assessed by using questionnaires which are to be completed at regular time points during the day.[day 1, 2, 3,4,5]

Secondary Outcome Measures

Name	Time	Method
one[not applicable]