Clinical trial NCT01526902: Proclear 1-D Multifocal Nondispensing Study
Official title: Proclear 1-D Multifocal Nondispensing Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Keywords: contact lenses
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2012-02-06
Enrollment: 49
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is designed to compare the relative performance related to subjective and objective vision between two multifocal soft contact lenses.

Detailed description: The aim of this study was to compare the subjective and objective vision. of Proclear® 1-D Multifocal test lenses (MF) with +0.75D overcorrection of the distance lens power in the nondominant eye compared to the Air Optix® Aqua Multifocal (CIBA VISION) contact lenses in low, Medium and High Add presbyopic subjects (+1.25 to +2.50 inclusive).

Eligibility criteria: Inclusion Criteria:

* Be between 40 and 65 years of age (inclusive)
* Require a reading addition of +1.25 to +2.50D (inclusive)
* Spherical distance CL or spectacle prescription between +3.00D and -5.00D(inclusive)
* Spectacle cylinder less than or equal to 0.75D in both eyes.
* Currently has a reading add correction in their spectacle or CL habitual correction (e.g. if myope, removes distance correction to read)
* Normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
* Have a minimum 2 weeks soft contact lens experience
* Be able to wear the study lens (e.g. good fit is attained and acceptable subjective comfort and vision for the duration of the study)
* Able to read, comprehend and sign an informed consent
* Willing to comply with the wear and study visit schedule
* Monocular best-corrected distance visual acuity ≥ 20/25 in each eye
* No gas permeable contact lens wear for 1 month prior to the study

Exclusion Criteria:

To be eligible for the study, each candidate must not present with any of the following

* Any active corneal infection, injury, inflammation, or ocular abnormality
* Systemic or ocular allergies, which might interfere with contact lens wear
* Systemic disease, which might interfere with contact lens wear
* Ocular disease, which might interfere with contact lens wear
* Pregnant or lactating
* Strabismus/amblyopia
* Habitually uncorrected anisometropia greater than or equal to 2.00 D
* Subjects who have undergone corneal refractive surgery
* Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear

Primary outcomes:
measure: Objective Vision Assessments: High Contrast Distance Visual Acuity
timeFrame: After 1 hour of lens wear
measure: Objective Vision Assessments: High Contrast Intermediate Visual Acuity
timeFrame: After 1 hour of lens wear
measure: Objective Vision Assessments: High Contrast Near Visual Acuity
timeFrame: After 1 hour of lens wear
Secondary outcomes:
measure: Subjective Overall Vision: High Contrast Distance Visual Quality
timeFrame: After 1 hour of lens wear
measure: Subjective Vision Assessments: High Contrast Intermediate Visual Quality
timeFrame: After 1 hour of lens wear
measure: Subjective Vision Assessments: High Contrast Near Visual Quality
timeFrame: After 1 hour of lens wear
Other outcomes:
Locations:
city: Bloomington,
country: United States
facility: Clinical Optics Research Lab, Indiana University,
state: Indiana
Study officials:
affiliation: Clinical Optics Research Lab, Indiana University, Bloomington, Indiana, USA
name: Peter Kollbaum, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References: