Changes in Invitro and ex Vivo Lens Metrology With Daily Wear Contact Lenses

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Acuvue 2; Device: Purevision; Device: Air Optix Aqua; Device: Biofinity; Device: Proclear; Device: Acuvue Oasys

• Registration Number: NCT01100411
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to evaluate changes in contact lens geometry after lens wear

Detailed Description

The purpose of this study is to evaluate changes invitro and ex vivo in contact lens geometry in daily lens wear

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-07
• Study First Submitted QC: 2010-04-07
• Study First Posted: 2010-04-09
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2011-11
• Last Update Submitted: 2012-07-17
• Last Update Posted: 2012-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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;
  • Has vision correctable to at least 6/12 (20/40) or better at distance in each eye with contact lenses;
  • Be experienced at wearing contact lenses.

Read More

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
  • An active corneal infection or any active ocular disease that would affect wearing of contact lenses;
  • Use of any topical ocular medication during trial with the exception of saline drops ;
  • 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
  • Eye surgery within 12 weeks immediately prior to enrolment for this trial;
  • Previous corneal refractive surgery;
  • Contraindications to contact lens wear;
  • Participated or currently enrolled in another clinical trial that may have affected vision or ocular physiology within the previous 2 weeks;
  • Be pregnant (formal testing of pregnancy is not required. A participant's verbal report is sufficient);
  • Worn soft contact lenses 2 calendar days or rigid gas permeable/ orthokeratology lenses 7 calendar days prior.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Acuvue 2	Acuvue 2	Contact lens material: Etafilcon A
Purevision	Purevision	Contact lens material: Balafilcon A
Air Optix Aqua	Air Optix Aqua	Contact lens material: Lotrafilcon A
Biofinity	Biofinity	Contact lens material: Comfilcon A
Proclear	Proclear	Contact lens material: Omafilcon A
Acuvue Oasys	Acuvue Oasys	Contact lens material: Senofilcon A

Primary Outcome Measures

Name	Time	Method
Lens Geometry	1 week

Secondary Outcome Measures

Name	Time	Method
Conjunctival Staining	1 week	The conjunctival staining
Corneal Shape	1 week

Trial Locations

Locations (1)

Institute for Eye Research; 🇦🇺 Sydney, New South Wales, Australia