Prospective, open labelled, randomised daily wear trial comparing the ocular response and product performance between 1 Day Acuvue Moist, 1 Day Acuvue TruEye and Acuvue Oasys contact lenses in new and experienced wearers

Not Applicable

Completed

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

• Registration Number: ACTRN12609000812291
• Lead Sponsor: Alcon Laboratories

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Participants in this 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;
- Has vision 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

Participants in this trial must not have:
- 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;
- Use of or a need for concurrent category S3 and above ocular medication up to 12 weeks prior to and during the trial;
- 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;
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;
- Currently enrolled in another clinical trial;
- Participation in a clinical trial within the previous 2 weeks or participation in a ‘short term’ clinical trial within the previous 48 hours;
- Be pregnant
- Allergy or intolerance to topical anaesthetics

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome: To evaluate the effect of lens wear on the ocular surface with 1 Day Acuvue Moist, 1 Day Acuvue TruEye and Acuvue Oasys by observing physiological variables including corneal staining.[At the baseline visit, 2 week, 1 month and 3 month visits]

Secondary Outcome Measures

Name	Time	Method
Secondary outcome: To evaluate the on eye performance of 1 Day Acuvue Moist, 1 Day Acuvue TruEye and Acuvue Oasys by observing ocular physiological variables such as redness, contact lens variables such as lens fit and subjective variables with questionnaires.[At the baseline visit, 2 week, 1 month and 3 month visits]