NCT Number: NCT02157909
DW Evaluation of Lotrafilcon B Lenses in a Modified Design
The purpose of this study is to demonstrate that Lotrafilcon B AIR OPTIX® AQUA sphere modified design lenses are noninferior to Lotrafilcon B AIR OPTIX® AQUA in overall lens fit by comparing the percent of subjects satisfying the "no re-fit" criteria in each treatment group.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Must sign an Informed Consent Document;
- Myopic, wear AIR OPTIX® AQUA lenses in the range of -1.00 to -5.00 diopters (D) in both eyes, and willing to comply with the wearing schedule;
- Manifest cylinder less than or equal to 0.75 D;
- Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance;
- Able to achieve distance visual acuity of at least 20/40 in each eye with habitual and study lenses;
- Wearing spherical AIR OPTIX® AQUA lenses in both eyes for at least 3 months (at least 8 hours per day, at least 5 days per week), wearing the habitual lenses for a minimum of 4 hours prior to the baseline study visit, and achieving an acceptable or optimal fit at baseline visit with habitual lenses in both eyes;
- Other protocol-defined criteria may apply.
Exclusion criteria
- Current soft contact lens wearer who regularly sleeps in lenses (1 or more nights per week);
- Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated including any use of topical ocular medications that would require instillation during contact lens wear;
- History of herpetic keratitis;
- History of corneal or refractive surgery or irregular cornea;
- A pathologically dry eye that precludes contact lens wear;
- Monocular (only one eye with functional vision);
- Monovision correction;
- History of intolerance or hypersensitivity to any component of the test articles or associated materials;
- Concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days;
- Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment;
- Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study;
- Other protocol-defined exclusion criteria may apply.
Treatment and study plan
Lotrafilcon B sphere contact lenses
DeviceOther names: AIR OPTIX® AQUA sphere, AOA
Primary outcomes
-
Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes
Time frame: Dispense (Day 0), Week 1
With the contact lens on eye, the investigator assessed the lens fit immediately post-blink and following lower lid margin push-up with the lower lid using a 5-point scale, where -2 = Unacceptably tight (reduced movement, unacceptable), -1 = Acceptably tight (reduced movement, acceptable), 0 = Optimal fit / movement, +1 = Acceptably loose (excessive movement, acceptable), and +2 = Unacceptably loose (excessive movement, unacceptable). To meet the definition of "no re-fit," an eye had to have an acceptable or optimal overall lens fit with the study lens, as well as be within 1 grade of the overall lens fit assessed with the habitual lens at baseline. Proportion of subjects is reported as a percentage.
Sponsors and collaborators
Lead sponsor
Alcon Research
Industry
Registry information
Official study title
Daily Wear (DW) Evaluation of Lotrafilcon B in a Modified Design
Important dates
- Study start
- 2014
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Jun 6, 2014
- Registry last updated
- Aug 11, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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