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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01100411
• Other study ID #: M-10-01
• Status: Completed
• Phase: N/A
• First received: April 7, 2010
• Last updated: July 17, 2012
• Start date: March 2010
• Est. completion date: July 2010

Study information

• Verified date: November 2011
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics CommitteeAustralia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

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

Locations

Country	Name	City	State
Australia	Institute for Eye Research	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lens Geometry		1 week	No
Secondary	Corneal Shape		1 week	No
Secondary	Conjunctival Staining	The conjunctival staining	1 week	Yes