Trial Outcomes & Findings for Clinical Comparison of Silicone Hydrogel Monthly Lenses (NCT NCT03169153)

Results Overview

Contact lens was removed aseptically from the eye. Total lipid (fatty deposits) uptake, defined as total amount of lipids (surface and bulk) absorbed/adsorbed and extracted, was measured in micrograms. A lower value indicates better results. Only one lens from each subject contributed to the analysis.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

114 participants

Primary outcome timeframe

Day 30 after 10 hours of wear, each product

Results posted on

2019-07-25

Participant Flow

Subjects were recruited from 1 study center located in the United Kingdom.

Of the 114 enrolled, 29 subjects were exited prior to randomization. An additional 4 subjects discontinued after randomization but prior to exposure. This reporting group includes all randomized and exposed subjects (81).

Participant milestones

Participant milestones
Measure	AOHG Then VITA Lotrafilcon B contact lenses worn first, followed by senofilcon C contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses were removed every night and cared for with the subject's habitual lens care solution.	VITA Then AOHG Senofilcon C contact lenses worn first, followed by lotrafilcon B contact lenses, as randomized. Each product worn bilaterally for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses were removed every night and cared for with the subject's habitual lens care solution.
Period 1, First 30 Days of Wear STARTED	42	39
Period 1, First 30 Days of Wear COMPLETED	39	35
Period 1, First 30 Days of Wear NOT COMPLETED	3	4
Period 2, Second 30 Days of Wear STARTED	39	34
Period 2, Second 30 Days of Wear COMPLETED	37	32
Period 2, Second 30 Days of Wear NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	AOHG Then VITA Lotrafilcon B contact lenses worn first, followed by senofilcon C contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses were removed every night and cared for with the subject's habitual lens care solution.	VITA Then AOHG Senofilcon C contact lenses worn first, followed by lotrafilcon B contact lenses, as randomized. Each product worn bilaterally for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses were removed every night and cared for with the subject's habitual lens care solution.
Period 1, First 30 Days of Wear Lost to Follow-up	1	1
Period 1, First 30 Days of Wear Withdrawal by Subject	2	3
Period 2, Second 30 Days of Wear Adverse Event	1	2
Period 2, Second 30 Days of Wear Could not attend visit	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=81 Participants Lotrafilcon B and senofilcon C contact lenses worn during Period 1 and Period 2 in a crossover assignment.
Age, Continuous	32.3 years STANDARD_DEVIATION 9.8 • n=81 Participants
Sex: Female, Male Female	60 Participants n=81 Participants
Sex: Female, Male Male	21 Participants n=81 Participants

PRIMARY outcome

Timeframe: Day 30 after 10 hours of wear, each product

Population: Full Analysis Set with non-missing response

Contact lens was removed aseptically from the eye. Total lipid (fatty deposits) uptake, defined as total amount of lipids (surface and bulk) absorbed/adsorbed and extracted, was measured in micrograms. A lower value indicates better results. Only one lens from each subject contributed to the analysis.

Outcome measures

Outcome measures
Measure	AOHG n=59 Participants Lotrafilcon B contact lenses worn bilaterally for 30 (+ 3) days under a daily wear modality. The lenses were removed every night and cared for with the subject's habitual lens care solution.	VITA n=56 Participants Senofilcon C contact lenses worn bilaterally for 30 (+ 3) days under a daily wear modality. The lenses were removed every night and cared for with the subject's habitual lens care solution.
Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens	78.1398 micrograms (μg) Standard Deviation 70.7923	307.6800 micrograms (μg) Standard Deviation 303.9299

Adverse Events

AOHG

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

VITA

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

CDMA Project Lead

Alcon Research

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