Proclear 1-D Multifocal Nondispensing Study
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ClinicalTrials.gov Identifier: NCT01526902 |
Recruitment Status
:
Completed
First Posted
: February 6, 2012
Results First Posted
: March 6, 2014
Last Update Posted
: April 7, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Presbyopia | Device: omafilcon A / PC 1-D MF Device: lotrafilcon B / Air Optix MF | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 49 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Proclear 1-D Multifocal Nondispensing Study |
Study Start Date : | February 2012 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |

Arm | Intervention/treatment |
---|---|
Active Comparator: omafilcon A / PC 1-D MF
omafilcon A (PC 1-D MF) / 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. |
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.
Other Name: Proclear Multifocal daily wear soft contact lenses
Device: 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
Other Name: Air OPtix Aqua Multifocal extended wear soft contact lenses
|
Active Comparator: lotrafilcon B / Air Optix MF
lotrafilcon B (AIR OPTIX MF) / 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. |
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.
Other Name: Proclear Multifocal daily wear soft contact lenses
Device: 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
Other Name: Air OPtix Aqua Multifocal extended wear soft contact lenses
|
- Objective Vision Assessments: High Contrast Distance Visual Acuity [ Time Frame: After 1 hour of lens wear ]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.
- Objective Vision Assessments: High Contrast Intermediate Visual Acuity [ Time Frame: After 1 hour of lens wear ]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.
- Objective Vision Assessments: High Contrast Near Visual Acuity [ Time Frame: After 1 hour of lens wear ]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.
- Subjective Overall Vision: High Contrast Distance Visual Quality [ Time Frame: After 1 hour of lens wear ]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.
- Subjective Vision Assessments: High Contrast Intermediate Visual Quality [ Time Frame: After 1 hour of lens wear ]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.
- Subjective Vision Assessments: High Contrast Near Visual Quality [ Time Frame: After 1 hour of lens wear ]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.

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Ages Eligible for Study: | 40 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01526902
United States, Indiana | |
Clinical Optics Research Lab, Indiana University, | |
Bloomington,, Indiana, United States, 47405 |
Principal Investigator: | Peter Kollbaum, OD, PhD | Clinical Optics Research Lab, Indiana University, Bloomington, Indiana, USA |
Responsible Party: | Coopervision, Inc. |
ClinicalTrials.gov Identifier: | NCT01526902 History of Changes |
Other Study ID Numbers: |
CV-12-02A |
First Posted: | February 6, 2012 Key Record Dates |
Results First Posted: | March 6, 2014 |
Last Update Posted: | April 7, 2014 |
Last Verified: | March 2014 |
Keywords provided by Coopervision, Inc.:
contact lenses |
Additional relevant MeSH terms:
Presbyopia Refractive Errors Eye Diseases |