Adults 18 to 55, any sex, with Myopia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Lens Centration AcceptancePrimary· after 15 minutes of contact lens wear
Investigator evaluated as acceptable (centered/slightly decentered) or unacceptable (substantially decentered). Number of eyes in each category will be reported by lens. This is an aggregate reporting of the lenses, combining the different base curves into a category by lens type. This is done per protocol, due to this primary outcome not being stratified by base curve.
Acceptable centration
Group
Value
95% CI
Galyfilcon A Plus (Test)
74
Galyfilcon A (Control)
62
Senofilcon A
69
Unacceptable centration
Group
Value
95% CI
Galyfilcon A Plus (Test)
8
Galyfilcon A (Control)
20
Senofilcon A
13
Primary Gaze Lens MovementPrimary· after 15 minutes of contact lens wear
Investigator evaluated as acceptable (minimal or moderate movement) or unacceptable (insufficient or excessive movement). Percent of eyes in each category will be evaluated.
Acceptable movement
Group
Value
95% CI
Galyfilcon AP 8.3 BC
93
Galyfilcon A 8.3 BC
93
Senofilcon A 8.4 BC
100
Galyfilcon AP 8.7 BC
93
Galyfilcon A 8.7 BC
90
Senofilcon A 8.8 BC
98
Unacceptable movement
Group
Value
95% CI
Galyfilcon AP 8.3 BC
7
Galyfilcon A 8.3 BC
7
Senofilcon A 8.4 BC
0
Galyfilcon AP 8.7 BC
7
Galyfilcon A 8.7 BC
10
Senofilcon A 8.8 BC
2
Fit AcceptabilityPrimary· after 15 minutes of contact lens wear
Investigator evaluated lens fit using a six point scale: 5-optimal...3-borderline acceptable...2-unacceptable. Percent of eyes in each category will be evaluated.
Acceptable Fit
Group
Value
95% CI
Galyfilcon AP 8.3 BC
90
Galyfilcon A 8.3 BC
90
Senofilcon A 8.4 BC
95
Galyfilcon AP 8.7 BC
83
Galyfilcon A 8.7 BC
71
Senofilcon A 8.8 BC
80
Unacceptable Fit
Group
Value
95% CI
Galyfilcon AP 8.3 BC
10
Galyfilcon A 8.3 BC
10
Senofilcon A 8.4 BC
5
Galyfilcon AP 8.7 BC
17
Galyfilcon A 8.7 BC
29
Senofilcon A 8.8 BC
20
New Lens Power Fit Match to Control LensesSecondary· after 15 minutes of contact lens wear
The lens power fit of test lenses will be compared to control lenses to determine if the power matches. Percent of eyes with exact power fit will be evaluated.
Lens Power the Same
Group
Value
95% CI
Galyfilcon AP 8.3 BC vs Galyfilcon A 8.3 BC
98
Galyfilcon AP 8.3 BC vs Senofilcon A 8.4 BC
98
Galyfilcon AP 8.7 BC vs Galyfilcon A 8.7 BC
98
Galyfilcon AP 8.7 BC vs Senofilcon A 8.8 BC
98
Lens Power Not the Same
Group
Value
95% CI
Galyfilcon AP 8.3 BC vs Galyfilcon A 8.3 BC
2
Galyfilcon AP 8.3 BC vs Senofilcon A 8.4 BC
2
Galyfilcon AP 8.7 BC vs Galyfilcon A 8.7 BC
2
Galyfilcon AP 8.7 BC vs Senofilcon A 8.8 BC
2
Sponsor's own description
The purpose of this study is to evaluate the comparability of lens fit and lens power of a new contact lens to the lens fit and lens power of two marketed lenses.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johnson & Johnson Vision Care, Inc.
Last refreshed: 19 June 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01244529.