A prospective, contralateral lens wear, randomised, controlled, 3-months clinical trial to test the efficacy and safety of a surface modified contact lens during continuous wear modality.

Phase 1

Completed

• Conditions: ocular inflammation and infection related to contact lens wear; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12615000725561
• Lead Sponsor: niversity of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 175

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 vision that is correctable to at least 6/12 (20/40) or better in each eye with contact lenses/spectacles.
*Require contact lens correction in each eye between -0.75 and -6.00 D inclusive.

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’s 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 any therapeutic ocular medication at enrolment (that would be required to be discontinued 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 risk providing a false positive.
*Eye surgery within 12 weeks immediately prior to enrolment for this trial.
*Previous corneal refractive surgery.
*Known allergy or intolerance to ingredients in any of the study products.
*Currently enrolled in another clinical trial or participation in a clinical trial within the previous 2 weeks.
*Pregnancy or lactating (Testing of pregnancy is not required. A participant’s verbal report is sufficient).

Study & Design

• Study Type: Interventional
• Study Design: Not specified