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Trial Outcomes & Findings for Multifocal High ADD Contact Lens Proof of Concept Trial (NCT NCT02117544)

NCT ID: NCT02117544

Last Updated: 2015-08-26

Results Overview

Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 40 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

268 participants

Primary outcome timeframe

Day 1, 10 minutes after lens insertion, each product

Results posted on

2015-08-26

Participant Flow

Subjects were recruited from 7 study centers located in the US.

Of the 268 enrolled, 159 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (109).

Participant milestones

Participant milestones
Measure
New MF, Then AOAMF
Lotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally for about 1 hour.
AOAMF, Then New MF
Lotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new). Each product worn bilaterally for about 1 hour.
Period 1
STARTED
54
55
Period 1
Treated
52
55
Period 1
COMPLETED
52
55
Period 1
NOT COMPLETED
2
0
Period 2
STARTED
52
55
Period 2
COMPLETED
52
55
Period 2
NOT COMPLETED
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
New MF, Then AOAMF
Lotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally for about 1 hour.
AOAMF, Then New MF
Lotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new). Each product worn bilaterally for about 1 hour.
Period 1
Lost to follow-up (prior to treatment)
2
0

Baseline Characteristics

Multifocal High ADD Contact Lens Proof of Concept Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall
n=107 Participants
AIR OPTIX® AQUA Multifocal and lotrafilcon B Multifocal (new design) contact lenses worn during Period 1 and Period 2 in a crossover assignment.
Age, Continuous
57.6 years
STANDARD_DEVIATION 5.0 • n=5 Participants
Sex: Female, Male
Female
91 Participants
n=5 Participants
Sex: Female, Male
Male
16 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Day 1, 10 minutes after lens insertion, each product

Population: This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).

Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 40 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.

Outcome measures

Outcome measures
Measure
New MF
n=104 Participants
Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
AOAMF
n=208 Eyes
Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
High Contrast Visual Acuity (HCVA) Near Monocular
0.18 logMAR
Standard Error 0.02
0.32 logMAR
Standard Error 0.02

SECONDARY outcome

Timeframe: Day 1, 10 minutes after lens insertion, each product

Population: This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).

Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.

Outcome measures

Outcome measures
Measure
New MF
n=208 Eyes
Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
AOAMF
n=208 Eyes
Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
HCVA Distance Monocular
0.11 logMAR
Standard Error 0.01
0.06 logMAR
Standard Error 0.01

SECONDARY outcome

Timeframe: Day 1, 10 minutes after lens insertion, each product

Population: This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).

Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 1 meter using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.

Outcome measures

Outcome measures
Measure
New MF
n=104 Participants
Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
AOAMF
n=208 Eyes
Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
HCVA Intermediate Monocular
0.04 logMAR
Standard Error 0.01
0.02 logMAR
Standard Error 0.01

SECONDARY outcome

Timeframe: Day 1, 10 minutes after lens insertion, each product

Population: This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).

Visual Acuity (clarity or sharpness of vision) was measured at low contrast level. LCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.

Outcome measures

Outcome measures
Measure
New MF
n=104 Participants
Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
AOAMF
n=208 Eyes
Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
Low Contrast Visual Acuity (LCVA) Distance Monocular
0.44 logMAR
Standard Error 0.01
0.39 logMAR
Standard Error 0.01

Adverse Events

Pre-treatment

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

New MF

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

AOAMF

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

Clinical Project Lead, Vision Care, GCRA

Alcon Research, Ltd

Phone: 1-888-451-3937

Results disclosure agreements

  • Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
  • Publication restrictions are in place

Restriction type: OTHER