Proclear 1-D Multifocal Nondispensing Study

Presbyopia Clinical Trial

Official title:

Proclear 1-D Multifocal Nondispensing Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526902
• Other study ID #: CV-12-02A
• Status: Completed
• Phase: N/A
• First received: February 2, 2012
• Last updated: March 7, 2014
• Start date: February 2012
• Est. completion date: May 2012

Study information

• Verified date: March 2014
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• omafilcon A / PC 1-D MF
Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.
• lotrafilcon B / Air Optix MF
Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses

Locations

Country	Name	City	State
United States	Clinical Optics Research Lab, Indiana University,	Bloomington,	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Vision Assessments: High Contrast Distance Visual Acuity	Tested with charts distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.	After 1 hour of lens wear	No
Primary	Objective Vision Assessments: High Contrast Intermediate Visual Acuity	Tested with charts at intermediate distance (100cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.	After 1 hour of lens wear	No
Primary	Objective Vision Assessments: High Contrast Near Visual Acuity	Tested with charts set at near point (40cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.	After 1 hour of lens wear	No
Secondary	Subjective Overall Vision: High Contrast Distance Visual Quality	Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.	After 1 hour of lens wear	No
Secondary	Subjective Vision Assessments: High Contrast Intermediate Visual Quality	Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.	After 1 hour of lens wear	No
Secondary	Subjective Vision Assessments: High Contrast Near Visual Quality	Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.	After 1 hour of lens wear	No