Clinical trial NCT02771145: Clinical Evaluation of the Safety and Efficacy of FID 120947A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2016-05-12
Enrollment: 91
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the safety and efficacy of FID 120947A in soft contact lens wearers of Japanese ethnicity.


Eligibility criteria: Inclusion Criteria:

* Successful history of silicone hydrogel or other soft contact lens wear (except for daily disposable lenses) in both eyes during the past 3 months and history of at least 5 consecutive days of successful DAILY wear in both eyes at Visit 1;
* Best spectacle corrected distance visual acuity greater than or equal to 0.8 (decimal visual acuity) in each eye;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any ocular or systemic medical condition that may, in the opinion of the Investigator, preclude safe administration of the investigational products or affect the results of this study;
* Need to wear contact lenses on an extended wear basis (ie, overnight) during the study;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Use of a daily cleaner and/or enzyme cleaner to care for lenses at least 7 days prior to Visit 1 (use of lens rewetting drops is acceptable);
* History of intolerance or hypersensitivity to any component of the investigational products;
* Unwilling or unable to abstain from use of all over-the-counter (OTC) or prescribed topical ocular medications (except for rewetting drops) within 7 days prior to Visit 1 and for the duration of the study;
* Moderate (grade 3) or severe (grade 4) corneal edema, corneal staining, injection (limbal hyperemia, bulbar conjunctival hyperemia), tarsal abnormalities, or "other" findings;
* Corneal vascularization that is mild (grade 2) or higher;
* Conjunctival or structural lid abnormalities or abnormal corneal opacities at Visit 1;
* Current or history of ocular infection, severe inflammation or disease within 6 months prior to Visit 1;
* Any systemic disease (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions;
* Use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1;
* Ocular or intra-ocular surgery and/or ocular trauma within the last 12 months (excluding placement of punctal plugs);
* Participation in any investigational clinical study within 30 days of Visit 1;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Eyes With Visibly Clean Lenses at Each Visit
timeFrame: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
measure: Number of Eyes With Film Deposits on Lens by Type at Each Visit
timeFrame: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
measure: Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit
timeFrame: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
measure: Percentage of Lens Area Covered by Film Deposits at Each Visit
timeFrame: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
measure: Percentage of Lens Area Covered by Crystalline Deposits at Each Visit
timeFrame: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
measure: Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit
timeFrame: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
measure: Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit
timeFrame: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
measure: Lens Wear Time at Each Visit Day
timeFrame: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
measure: Average Rewetting Drop Frequency at Each Visit
timeFrame: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
measure: Number of Unscheduled Lens Replacements by Reason
timeFrame: Up to Day 180
measure: Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
timeFrame: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
measure: Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
timeFrame: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
measure: Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
timeFrame: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Contact Alcon Japan, Ltd. for Trial Locations
Study officials:
affiliation: Alcon Japan, Ltd.
name: Group Manager, Clinical Development
role: STUDY_DIRECTOR
References: