Lid Wiper Epitheliopathy: Exploring the links with osmolality and ocular comfort during contact lens wear

A prospective, randomised, double-masked, controlled, cross-over study of the effects of wearing lotrafilcon A versus comfilcom A silicone hydrogel lenses for up to 10 days on lid wiper epitheliopathy in healthy lens wearing participants.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000204044

Enrollment

Registered

2010-03-10

Start date

2010-09-23

Completion date

2010-11-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project aims to deepen our understanding of the causes of discomfort during contact lens wear. Participants will wear two types of contact lenses (lotrafilcon and comfilcon) for up to 10 days at a time.The project hypothesises that there is a link between the saltiness of peoples' tears, of their contact lenses and the presence of superficial damage to the portion of the upper eyelid that wipes over the contact lens and the sensation of discomfort during lens wear.

Interventions

Participants will be randomised to wear either lotrafilcon A silicone hydrogel contact lenses on a daily wear basis for up to 10 days OR comfilcon A silicone hydrogel contact lenses on a daily wear basis flor up to 10 days and then, following a washout period of 7 days where no lenses are worn, crossed over to the other lens group. Hydrogen peroxide disinfection system (AOSept or Omnicare) will be used for disinfection after each day of wear.

Study design

Allocation

Randomised controlled trial

Primary purpose

Diagnosis

Masking

Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Ability to wear contact lenses, no contraindications to lens wear, no lens wear in the past 7 days

Exclusion criteria

Required use of any ocular eye drops other than unit dose saline rewetting drops during the study period

Outcome results