Proclear 1-D Multifocal Nondispensing Study

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01526902
• Collaborator: (none)
• Enrollment: 49
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 16.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Device: omafilcon A / PC 1-D MF; Device: lotrafilcon B / Air Optix MF	N/A

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).

Study Design

• Study Type: Interventional
• 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: Feb 1, 2012
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

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 Names: 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 Names: 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 Names: 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 Names: Air OPtix Aqua Multifocal extended wear soft contact lenses

Outcome Measures

Primary Outcome Measures

1. Objective Vision Assessments: High Contrast Distance Visual Acuity [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.

2. Objective Vision Assessments: High Contrast Intermediate Visual Acuity [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.

3. Objective Vision Assessments: High Contrast Near Visual Acuity [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.

Secondary Outcome Measures

1. Subjective Overall Vision: High Contrast Distance Visual Quality [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.

2. Subjective Vision Assessments: High Contrast Intermediate Visual Quality [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.

3. Subjective Vision Assessments: High Contrast Near Visual Quality [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 65 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Optics Research Lab, Indiana University,	Bloomington,	Indiana	United States	47405

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Peter Kollbaum, OD, PhD, Clinical Optics Research Lab, Indiana University, Bloomington, Indiana, USA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT01526902
• Other Study ID Numbers: CV-12-02A
• First Posted: Feb 6, 2012
• Last Update Posted: Apr 7, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by Coopervision, Inc.: contact lenses
• Additional relevant MeSH terms: Presbyopia

Study Results

Participant Flow

Recruitment Details	Recruitment was open between 06FEB2012 and 28FEB2012
Pre-assignment Detail	The subjects who are current contact lens wearers should attend the first visit wearing their habitual lenses and having worn them that day for at least 2 hours prior to the visit.

Arm/Group Title	Omafilcon A (PC 1-D MF) / Lotrafilcon B (AIR OPTIX MF)	Lotrafilcon B (AIR OPTIX MF) / Omafilcon A (PC 1-D MF)
Arm/Group Description	Subjects were randomly assigned into either the omafilcon A (PC 1-D) Multifocal with +0.75D over-correction in the non-dominant eye or the Air Optix Aqua (lotrafilcon B)Multifocal lenses as their initial pair. Lens Pair 1 were evaluated for fit, vision and comfort (1 hour after lens application). Following this evaluation and during this same visit, the subject then crossed-over into the alternative pair of study lenses. This second pair of lenses was also evaluated for fit, vision and comfort (1 hour after lens application).	Subjects were randomly assigned into either the omafilcon A (PC 1-D) Multifocal with +0.75D over-correction in the non-dominant eye or the Air Optix Aqua (lotrafilcon B)Multifocal lenses as their initial pair. Lens Pair 1 were evaluated for fit, vision and comfort (1 hour after lens application). Following this evaluation and during this same visit, the subject then crossed-over into the alternative pair of study lenses. This second pair of lenses was also evaluated for fit, vision and comfort (1 hour after lens application).
Period Title: Overall Study
STARTED	25	24
COMPLETED	25	24
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study Population
Arm/Group Description	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.
Overall Participants	49
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	49 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53 (6)
Sex: Female, Male (Count of Participants)
Female	39 79.6%
Male	10 20.4%
Region of Enrollment (participants) [Number]
United States	49 100%

Outcome Measures

1. Primary Outcome

Title	Objective Vision Assessments: High Contrast Distance Visual Acuity
Description	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.
Time Frame	After 1 hour of lens wear

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	PC1DMF	Air Optix MF
Arm/Group Description	(Test Lens) omafilcon A Proclear 1-D multifocal lens	(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
Measure Participants	49	49
Mean (Standard Deviation) [logMAR units]	-0.09 (0.08)	-0.05 (0.08)

2. Secondary Outcome

Title	Subjective Overall Vision: High Contrast Distance Visual Quality
Description	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.
Time Frame	After 1 hour of lens wear

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	PC1DMF	Air Optix MF
Arm/Group Description	(Test Lens) omafilcon A Proclear 1-D multifocal lens	(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
Measure Participants	49	49
Mean (Standard Deviation) [units on a scale]	87 (16)	88 (11)

3. Secondary Outcome

Title	Subjective Vision Assessments: High Contrast Intermediate Visual Quality
Description	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.
Time Frame	After 1 hour of lens wear

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	PC1DMF	Air Optix MF
Arm/Group Description	(Test Lens) omafilcon A Proclear 1-D multifocal lens	(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
Measure Participants	49	49
Mean (Standard Deviation) [units on a scale]	85 (15)	85 (15)

4. Primary Outcome

Title	Objective Vision Assessments: High Contrast Intermediate Visual Acuity
Description	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.
Time Frame	After 1 hour of lens wear

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	PC1DMF	Air Optix MF
Arm/Group Description	(Test Lens) omafilcon A Proclear 1-D multifocal lens	(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
Measure Participants	49	49
Mean (Standard Deviation) [logMAR units]	-0.11 (0.08)	-0.10 (0.09)

5. Primary Outcome

Title	Objective Vision Assessments: High Contrast Near Visual Acuity
Description	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.
Time Frame	After 1 hour of lens wear

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	PC1DMF	Air Optix MF
Arm/Group Description	(Test Lens) omafilcon A Proclear 1-D multifocal lens	(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
Measure Participants	49	49
Mean (Standard Deviation) [logMAR units]	0.08 (0.14)	0.05 (0.12)

6. Secondary Outcome

Title	Subjective Vision Assessments: High Contrast Near Visual Quality
Description	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.
Time Frame	After 1 hour of lens wear

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	PC1DMF	Air Optix MF
Arm/Group Description	(Test Lens) omafilcon A Proclear 1-D multifocal lens	(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
Measure Participants	49	49
Mean (Standard Deviation) [units on a scale]	81 (18)	80 (18)

Adverse Events

Arm/Group Title	Omafilcon A / PC1DMF L2A (TEST)		Lotrafilcon B / Air Optix MF (CONTROL)
Arm/Group Description	Low-Med and High Add power groups were randomly assigned to either omafilcon A/Proclear Multifocal soft contact lenses (PC1DMF L2A) or lotrafilcon B/Air OPtix Aqua Multifocal soft contact lenses (Air Optix MF) then crossed-over into the alternative pair of study lenses.		Low-Med and High Add power groups were randomly assigned to either omafilcon A/Proclear Multifocal soft contact lenses (PC1DMF L2A) or lotrafilcon B/Air OPtix Aqua Multifocal soft contact lenses (Air Optix MF) then crossed-over into the alternative pair of study lenses.
All Cause Mortality
	Omafilcon A / PC1DMF L2A (TEST)		Lotrafilcon B / Air Optix MF (CONTROL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Omafilcon A / PC1DMF L2A (TEST)		Lotrafilcon B / Air Optix MF (CONTROL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/49 (0%)
Other (Not Including Serious) Adverse Events
	Omafilcon A / PC1DMF L2A (TEST)		Lotrafilcon B / Air Optix MF (CONTROL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/49 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.