Trial Outcomes & Findings for Daily Disposable Toric Comparative Trial in Europe (NCT NCT01070381)

Results Overview

Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured on a 10-point scale, with 1 being poor and 10 being excellent.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

220 participants

Primary outcome timeframe

1 week of wear

Results posted on

2013-12-13

Participant Flow

Three participants were enrolled but not dispensed due to failing inclusion/exclusion criteria. These participants were included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.

Participant milestones

Participant milestones
Measure	Nelfilcon A / Ocufilcon D Nelfilcon A contact lenses worn first, with ocufilcon D contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.	Ocufilcon D / Nelfilcon A Ocufilcon D contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Period 1, 1 Week of Wear STARTED	109	107
Period 1, 1 Week of Wear COMPLETED	109	107
Period 1, 1 Week of Wear NOT COMPLETED	0	0
Period 2, 1 Week of Wear STARTED	109	107
Period 2, 1 Week of Wear COMPLETED	108	106
Period 2, 1 Week of Wear NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Nelfilcon A / Ocufilcon D Nelfilcon A contact lenses worn first, with ocufilcon D contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.	Ocufilcon D / Nelfilcon A Ocufilcon D contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Period 2, 1 Week of Wear Handling	0	1
Period 2, 1 Week of Wear Unacceptable Vision	1	0

Baseline Characteristics

Daily Disposable Toric Comparative Trial in Europe

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=217 Participants This reporting group includes all enrolled and dispensed subjects
Age, Continuous	33.2 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	151 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week of wear

Population: Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Outcome measures
Measure	Nelfilcon A n=213 Participants Commercially marketed, toric, soft contact lens for daily disposable wear	Ocufilcon D n=213 Participants Commercially marketed, toric, soft contact lens for daily disposable wear
Overall Comfort	7.6 Units on a Scale Standard Deviation 1.9	7.6 Units on a Scale Standard Deviation 1.9

Adverse Events

Nelfilcon A

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Ocufilcon D

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nelfilcon A n=217 participants at risk Commercially marketed, toric, soft contact lens for daily disposable wear	Ocufilcon D n=216 participants at risk Commercially marketed, toric, soft contact lens for daily disposable wear
Eye disorders 3-grade change in symptoms (frequency and/or severity) from baseline	7.4% 16/217 • Number of events 16 • Adverse event data were collected for the duration of the trial = 87 days. Individual exposure = 2 weeks (1 week per product) All enrolled and exposed participants. Common lens-related symptoms were collected at baseline. Any 3-grade change (1 or more symptoms) from baseline in frequency or severity was recorded as an adverse event. Frequency was collected on a 5-point scale, with 0=never and 4=always. Severity was collected on a 5-point scale, with 0=none and 4=severe.	12.5% 27/216 • Number of events 35 • Adverse event data were collected for the duration of the trial = 87 days. Individual exposure = 2 weeks (1 week per product) All enrolled and exposed participants. Common lens-related symptoms were collected at baseline. Any 3-grade change (1 or more symptoms) from baseline in frequency or severity was recorded as an adverse event. Frequency was collected on a 5-point scale, with 0=never and 4=always. Severity was collected on a 5-point scale, with 0=none and 4=severe.

Additional Information

Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs

CIBA VISION

Phone: 1-800-241-7629

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.
Publication restrictions are in place

Restriction type: OTHER