Daily replacement of contact lenses during extended wear.

Phase 3

Completed

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

• Registration Number: ACTRN12608000036314
• Lead Sponsor: Institute for Eye Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Pre-existing ocular irritation that would preclude contact lens fitting;
Had eye surgery within 12 weeks immediately prior to enrollment for this trial;
Undergone corneal refractive surgery;
Worn RGP’s or orthokeratology lenses within the previous two weeks
Contraindications to soft contact lens wear;
Contraindication / allergy to in-eye solutions
Be currently enrolled in another clinical trial or have participated in a clinical trial within the previous two weeks.
Pregnant or lactating women not able to complete the study (Investigator discretion)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine if daily replacement of lenses during continuous (or extended) wear reduces contact lens related ocular adverse events compareed to adverse event rates in historical control trial. Examples of CL-related ocular AE's include infectious (microbial keratitis [MK]), inflammation of the cornea (contact lens induced peripheral and non-infection corneal ulcer [CLPU], contact lens induced acute red eye [CLARE], infiltrative keratitis [IK]), inflammation of the conjunctiva (contact lens induced papillary conjunctivitis [CLPC]), corneal erosion, superior epithelial arcuate lesion (SEAL). Adverse events will be assessed with a slit lamp biomicroscope (including corneal and conjunctival staining with fluorescein).[The duration of the study is 3 months. Participants may be assessed for adverse events at scheduled visits (1 week daily lens weart [neophytes only], 1 week extended wear (EW), 1 month EW and 3 months extended wear) and at unscheduled visits.]

Secondary Outcome Measures

Name	Time	Method
/A[N/A]