Clinical trial NCT03034928: Clinical Biocompatibility Evaluation of Contact Lens Coatings
Official title: Clinical Biocompatibility Evaluation of Contact Lens Coatings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Ametropia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2017-01-27
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate corneal staining observed after 2 hours of wear with contact lenses with investigational coating against PureVision™ lenses, all pre-cycled with OPTI-FREE® RepleniSH® multi-purpose disinfection solution.

Detailed description: In this contralateral crossover study, qualifying subjects will wear a total of 2 pairs of study contact lenses. Lenses will be worn according to a randomized lens sequence assignment. Each pair will consist of a test lens (Test 1 or Test 2) and a control lens.

Eligibility criteria: Inclusion Criteria:

* Able to understand and must sign an Informed Consent;
* Successful wearer of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
* Manifest cylinder less than or equal to 1.50 diopter (D) in each eye;
* Best Corrected Visual Acuity (BCVA) 20/25 or better in each eye;
* VA with habitual spectacles 20/40 in both eyes (OU) or better and willing to wear spectacles as needed during the washout period and during study lens exposure;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
* History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye;
* Ocular or intra-ocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
* Current or history of pathologically dry eye in either eye that would preclude contact lens wear;
* Current or history of herpetic keratitis in either eye;
* Eye injury in either eye within 12 weeks immediately prior to enrollment;
* History of intolerance or hypersensitivity to any component of the study lenses or solutions;
* Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
* Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Average Percent Area of Solution-related Corneal Staining
timeFrame: Day 1 after 2 hours of wear, each product
Secondary outcomes:
Other outcomes:
Locations:
city: Johns Creek
country: United States
facility: Alcon Investigative Site
state: Georgia
Study officials:
affiliation: Alcon, A Novartis Division
name: Sr. Clinical Manager, Trial Management Operations
role: STUDY_DIRECTOR
References: