Trial Outcomes & Findings for Proclear 1-D Multifocal Nondispensing Study (NCT NCT01526902)

NCT ID: NCT01526902

Last Updated: 2014-04-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

49 participants

Primary outcome timeframe

After 1 hour of lens wear

Results posted on

2014-04-07

Participant Flow

Recruitment was open between 06FEB2012 and 28FEB2012

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.

Participant milestones

Participant milestones
Measure	Omafilcon A (PC 1-D MF) / Lotrafilcon B (AIR OPTIX MF) 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).	Lotrafilcon B (AIR OPTIX MF) / Omafilcon A (PC 1-D MF) 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).
Overall Study STARTED	25	24
Overall Study COMPLETED	25	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Proclear 1-D Multifocal Nondispensing Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study Population n=49 Participants 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.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	53 years STANDARD_DEVIATION 6 • n=93 Participants
Sex: Female, Male Female	39 Participants n=93 Participants
Sex: Female, Male Male	10 Participants n=93 Participants
Region of Enrollment United States	49 participants n=93 Participants

PRIMARY outcome

Timeframe: After 1 hour of lens wear

Population: Per Protocol

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.

Outcome measures

Outcome measures
Measure	PC1DMF n=49 Participants (Test Lens) omafilcon A Proclear 1-D multifocal lens	Air Optix MF n=49 Participants (Control Lens) lotrafilcon B Air Optix Aqua Multifocal
Objective Vision Assessments: High Contrast Distance Visual Acuity	-0.09 logMAR units Standard Deviation 0.08	-0.05 logMAR units Standard Deviation 0.08

PRIMARY outcome

Timeframe: After 1 hour of lens wear

Population: Per Protocol

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.

Outcome measures

Outcome measures
Measure	PC1DMF n=49 Participants (Test Lens) omafilcon A Proclear 1-D multifocal lens	Air Optix MF n=49 Participants (Control Lens) lotrafilcon B Air Optix Aqua Multifocal
Objective Vision Assessments: High Contrast Intermediate Visual Acuity	-0.11 logMAR units Standard Deviation 0.08	-0.10 logMAR units Standard Deviation 0.09

PRIMARY outcome

Timeframe: After 1 hour of lens wear

Population: Per Protocol

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.

Outcome measures

Outcome measures
Measure	PC1DMF n=49 Participants (Test Lens) omafilcon A Proclear 1-D multifocal lens	Air Optix MF n=49 Participants (Control Lens) lotrafilcon B Air Optix Aqua Multifocal
Objective Vision Assessments: High Contrast Near Visual Acuity	0.08 logMAR units Standard Deviation 0.14	0.05 logMAR units Standard Deviation 0.12

SECONDARY outcome

Timeframe: After 1 hour of lens wear

Population: Per Protocol

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.

Outcome measures

Outcome measures
Measure	PC1DMF n=49 Participants (Test Lens) omafilcon A Proclear 1-D multifocal lens	Air Optix MF n=49 Participants (Control Lens) lotrafilcon B Air Optix Aqua Multifocal
Subjective Overall Vision: High Contrast Distance Visual Quality	87 units on a scale Standard Deviation 16	88 units on a scale Standard Deviation 11

SECONDARY outcome

Timeframe: After 1 hour of lens wear

Population: Per Protocol

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.

Outcome measures

Outcome measures
Measure	PC1DMF n=49 Participants (Test Lens) omafilcon A Proclear 1-D multifocal lens	Air Optix MF n=49 Participants (Control Lens) lotrafilcon B Air Optix Aqua Multifocal
Subjective Vision Assessments: High Contrast Intermediate Visual Quality	85 units on a scale Standard Deviation 15	85 units on a scale Standard Deviation 15

SECONDARY outcome

Timeframe: After 1 hour of lens wear

Population: Per Protocol

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.

Outcome measures

Outcome measures
Measure	PC1DMF n=49 Participants (Test Lens) omafilcon A Proclear 1-D multifocal lens	Air Optix MF n=49 Participants (Control Lens) lotrafilcon B Air Optix Aqua Multifocal
Subjective Vision Assessments: High Contrast Near Visual Quality	81 units on a scale Standard Deviation 18	80 units on a scale Standard Deviation 18

Adverse Events

Lotrafilcon B / Air Optix MF (CONTROL)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Omafilcon A / PC1DMF L2A (TEST)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pete Kollbaum, OD, PhD, FAAO, FBCLA, Principal Investigator

Indiana University

Phone: 812-856-0108

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60