Changes in Invitro and ex Vivo Lens Metrology With Daily Wear Contact Lenses
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01100411
First received: April 7, 2010
Last updated: July 17, 2012
Last verified: November 2011
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Purpose
The purpose of this study is to evaluate changes in contact lens geometry after lens wear
| Condition | Intervention |
|---|---|
|
Myopia |
Device: Air Optix Aqua Device: Biofinity Device: Proclear Device: Acuvue Oasys Device: Acuvue 2 Device: Purevision |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Changes in Invitro and ex Vivo Lens Metrology With Experienced Daily Wear Contact Lens Wearers |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Lens Geometry [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Corneal Shape [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Conjunctival Staining [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]The conjunctival staining
| Enrollment: | 35 |
| Study Start Date: | March 2010 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Air Optix Aqua
Contact lens material: Lotrafilcon A
|
Device: Air Optix Aqua
Contact lens material: Lotrafilcon A
Other Name: Air Optix
|
|
Active Comparator: Biofinity
Contact lens material: Comfilcon A
|
Device: Biofinity
Contact lens material: Comfilcon A
Other Name: CV Biofininty
|
|
Active Comparator: Proclear
Contact lens material: Omafilcon A
|
Device: Proclear
Contact lens material: Omafilcon A
Other Name: Proclear Compatibles
|
|
Active Comparator: Acuvue Oasys
Contact lens material: Senofilcon A
|
Device: Acuvue Oasys
Contact lens material: Senofilcon A
Other Name: Oasys
|
|
Active Comparator: Acuvue 2
Contact lens material: Etafilcon A
|
Device: Acuvue 2
Contact lens material: Etafilcon A
Other Name: AV 2
|
|
Active Comparator: Purevision
Contact lens material: Balafilcon A
|
Device: Purevision
Contact lens material: Balafilcon A
Other Name: PV
|
Detailed Description:
The purpose of this study is to evaluate changes invitro and ex vivo in contact lens geometry in daily lens wear
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT01100411 History of Changes |
| Other Study ID Numbers: | M-10-01 |
| Study First Received: | April 7, 2010 |
| Last Updated: | July 17, 2012 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: Human Research Ethics Committee Australia: National Health and Medical Research Council |
Keywords provided by Alcon Research:
|
Contact lenses, myopia, lens geometry |
Additional relevant MeSH terms:
|
Myopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on May 21, 2013