Trial Outcomes & Findings for Effect of Head and Gaze Position on Soft Toric Contact Lens Performance (NCT NCT01579045)

Results Overview

rotation from zero position also described as absolute value of the rotation.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

up to 60 minutes in recumbent position

Results posted on

2018-06-19

Participant Flow

Subjects were recruited and screened based on the inclusion/exclusion criteria.

Participant milestones

Participant milestones
Measure	All Subjects All subjects who were enrolled.
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Head and Gaze Position on Soft Toric Contact Lens Performance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Subjects n=24 Participants All subjects who were enrolled, and completed the study.
Age, Continuous	43.2 years STANDARD_DEVIATION 15.3 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United Kingdom	24 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 60 minutes in recumbent position

Population: Subjects analyzed were those enrolled, randomized, and whom completed the study.

rotation from zero position also described as absolute value of the rotation.

Outcome measures

Outcome measures
Measure	Senofilcon A (AOfA) n=24 Participants As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.	Filcon II 3 (Sauflon) n=24 Participants As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.	Etafilcon A (1DAMfA) n=24 Participants As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.	Filcon II 3 (C1DT) n=24 Participants As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.	Nelfilcon A (FDT) n=24 Participants As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
Lens Orientation in Recumbent Position	15.8 degrees Interval 11.23 to 20.44	35.2 degrees Interval 30.62 to 39.79	19.4 degrees Interval 14.6 to 24.22	29.1 degrees Interval 24.23 to 33.95	21.7 degrees Interval 16.86 to 26.48

SECONDARY outcome

Timeframe: up to 60 minutes in recumbent position

Population: Analysis is on those who were enrolled, randomized, and whom completed the study.

Visual Acuity measured in LogMAR units. High contrast visual acuity (VA) was measured in both eyes using a 3m LogMAR test chart at 2.5m testing distance (subsequently converted).