Changes in Invitro and ex Vivo Lens Metrology With Daily Wear Contact Lenses
1 other identifier
interventional
35
1 country
1
Brief Summary
The purpose of this study is to evaluate changes in contact lens geometry after lens wear
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 7, 2010
CompletedFirst Posted
Study publicly available on registry
April 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedJuly 18, 2012
November 1, 2011
4 months
April 7, 2010
July 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lens Geometry
1 week
Secondary Outcomes (2)
Corneal Shape
1 week
Conjunctival Staining
1 week
Study Arms (6)
Air Optix Aqua
ACTIVE COMPARATORContact lens material: Lotrafilcon A
Biofinity
ACTIVE COMPARATORContact lens material: Comfilcon A
Proclear
ACTIVE COMPARATORContact lens material: Omafilcon A
Acuvue Oasys
ACTIVE COMPARATORContact lens material: Senofilcon A
Acuvue 2
ACTIVE COMPARATORContact lens material: Etafilcon A
Purevision
ACTIVE COMPARATORContact lens material: Balafilcon A
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Institute for Eye Research
Sydney, New South Wales, 2052, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Alcon Call Center
Alcon Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2010
First Posted
April 9, 2010
Study Start
March 1, 2010
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
July 18, 2012
Record last verified: 2011-11