Clinical trial NCT02157909: DW Evaluation of Lotrafilcon B Lenses in a Modified Design
Official title: Daily Wear (DW) Evaluation of Lotrafilcon B in a Modified Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Lens fit
contact lenses
myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-06-06
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes
timeFrame: Dispense (Day 0), Week 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Clinical Trial Manager, Vision Care, GCRA
role: STUDY_DIRECTOR
References: