NCT02956460

Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses

Completed NA Results posted Last updated 2 April 2018

What this trial tests

NA trial testing fanfilcon A in Myopia in 64 participants. Completed in 14 December 2016.

Timeline

27 October 2016

Primary endpoint
14 December 2016

14 December 2016

Quick facts

Lead sponsor	CooperVision, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	64
Start date	27 October 2016
Primary completion	14 December 2016
Estimated completion	14 December 2016
Sites	4 locations across United States

Drugs / interventions tested

• fanfilcon A
• senofilcon A — full drug profile →

Conditions studied

• Myopia — all drugs for Myopia →

Sponsor

CooperVision, Inc.

Who can join

Adults 18 to 40, 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.

Overall Comfort Primary · 2 weeks

Subjective assessment for comfort is assessed. Scale 0-10, 0=painful, 10=can't feel

Group	Value	95% CI
Fanfilcon A	8.4	± 1.9
Senofilcon A	8.7	± 1.5

Overall Dryness Primary · 2 weeks

Subjective ratings for dryness is assessed on a scale of 0-10, 0=extremely dry, 10=no dryness

Group	Value	95% CI
Fanfilcon A	8.2	± 1.9
Senofilcon A	8.2	± 1.9

Vision Quality Primary · 2 weeks

Subjective ratings of vision quality is assessed on a scale 0-10, 0=not sharp/not clear, 10=sharp/clear

Group	Value	95% CI
Fanfilcon A	9.0	± 1.5
Senofilcon A	8.9	± 1.6

Lens Handling Primary · 2 weeks

Subjective ratings of lens handling - insertion and removal - is assessed using scale 0-10, 0=difficult to handle, 10=very easy to handle

Insertion

Group	Value	95% CI
Fanfilcon A	9.3	± 1.3
Senofilcon A	9.4	± 1.2

Removal

Group	Value	95% CI
Fanfilcon A	8.4	± 2.0
Senofilcon A	9.3	± 1.3

Vision Satisfaction Primary · 2 weeks

Subjective ratings of vision satisfaction is assessed on a scale 0-10, 0=completely dissatisfied, 10=completely satisfied.

Group	Value	95% CI
Fanfilcon A	8.7	± 2.1
Senofilcon A	8.6	± 1.7

Lens Centration Primary · 2 weeks

Lens centration will be recorded by degree and direction in the primary position. (Optimum, decentration acceptable, decentration unacceptable).

Group	Value	95% CI
Fanfilcon A	62
Senofilcon A	63
Fanfilcon A	1
Senofilcon A	0
Fanfilcon A	0
Senofilcon A	0

Conjunctival Staining Primary · 2 weeks

Assessed using slit lamp with blue light and sodium fluorescein, low medium magnification. 0=None, no staining present 1. Very slight 2. Slight 3. Moderate 4. Severe

Group	Value	95% CI
Fanfilcon A	0.4	± 0.7
Senofilcon A	0.6	± 0.8

Smoothness Primary · 2 weeks

Subjective ratings for lens sensation of smoothness is assessed on a scale 0-10, 0=not smooth at all, 10=totally smooth

Group	Value	95% CI
Fanfilcon A	8.7	± 1.7
Senofilcon A	9.1	± 1.4

Clean Feeling Primary · 2 weeks

Subjective ratings for lens clean feeling is assessed on a scale 0-10, 0=not clean at all, 10=lenses feel perfectly clean

Group	Value	95% CI
Fanfilcon A	8.7	± 1.7
Senofilcon A	8.9	± 1.4

Lens Hydrated Primary · 2 weeks

Subjective ratings for lens sensation is assessed on a scale 0-10, 0=totally dehydrated, 10=totally hydrated

Group	Value	95% CI
Fanfilcon A	8.3	± 2.0
Senofilcon A	8.5	± 1.6

Lens Wettability Primary · 2 weeks

Subjective ratings for lens wettability is assessed on a scale 0-10, 0=non-wettable, 10=highly wettable

Group	Value	95% CI
Fanfilcon A	8.4	± 1.9
Senofilcon A	8.5	± 1.6

Sponsor's own description

Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1 month dispensing study (2 weeks each lens pair)

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.