Trial Outcomes & Findings for Comparison of Two Marketed Silicone Hydrogel Lenses (NCT NCT02495948)

Results Overview

The contact lens (right eye) was removed and stored dry and frozen until analysis. Total cholesterol deposits (cholesterol and cholesterol esters) were extracted from the lens and measured in micrograms. Lower deposits indicate increased lens performance. Study originally intended to analyze 36 lenses per arm, but actual number of lenses analyzed was less due to measurement error.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

168 participants

Primary outcome timeframe

Day 30, each product

Results posted on

2016-12-28

Participant Flow

Participants were recruited from 10 investigational sites located in the US.

Of the 168 enrolled, 1 participant was exited as a screen failure prior to randomization. This reporting group includes all randomized participants (167).

Participant milestones

Participant milestones
Measure	AOA Then ULTRA Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.	ULTRA Then AOA Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
Period 1, First 30 Days of Wear STARTED	83	84
Period 1, First 30 Days of Wear COMPLETED	83	83
Period 1, First 30 Days of Wear NOT COMPLETED	0	1
Period 2, Second 30 Days of Wear STARTED	83	83
Period 2, Second 30 Days of Wear COMPLETED	82	82
Period 2, Second 30 Days of Wear NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	AOA Then ULTRA Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.	ULTRA Then AOA Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
Period 1, First 30 Days of Wear Adverse Event	0	1
Period 2, Second 30 Days of Wear Withdrawal by Subject	1	1

Baseline Characteristics

Comparison of Two Marketed Silicone Hydrogel Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=167 Participants Lotrafilcon B and samfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.
Age, Continuous	31.9 years STANDARD_DEVIATION 9.01 • n=93 Participants
Gender Female	130 Participants n=93 Participants
Gender Male	37 Participants n=93 Participants

PRIMARY outcome

Timeframe: Day 30, each product

Population: Intent-to-Treat analysis set

The contact lens (right eye) was removed and stored dry and frozen until analysis. Total cholesterol deposits (cholesterol and cholesterol esters) were extracted from the lens and measured in micrograms. Lower deposits indicate increased lens performance. Study originally intended to analyze 36 lenses per arm, but actual number of lenses analyzed was less due to measurement error.

Outcome measures

Outcome measures
Measure	AIR OPTIX AQUA (AOA) n=34 Lenses Lotrafilcon B contact lenses worn during Period 1 or Period 2 for 30 days	ULTRA n=33 Lenses Samfilcon A contact lenses worn during Period 1 or Period 2 for 30 days
Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear	1.63 micrograms Standard Deviation 2.21	4.89 micrograms Standard Deviation 3.12

Adverse Events

Pretreatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AIR OPTIX AQUA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ULTRA

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

Global Medical Affairs Brand Lead, Vision Care

Alcon, A Novartis Division

Phone: 1-888-451-3937

Email: [email protected]

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