NCT04050618 is a NA clinical trial of fanfilcon A test lens in Myopia, sponsored by CooperVision, Inc..

Who is sponsoring NCT04050618?

NCT04050618 is sponsored by CooperVision, Inc..

What drugs are being tested in NCT04050618?

Interventions in NCT04050618: fanfilcon A test lens, ocufilcon D control lens, etafilcon A control lens.

Is NCT04050618 still recruiting?

NCT04050618 is currently completed. Last updated 19 October 2020.

Are results published for NCT04050618?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-10-19 · How we verify

NCT04050618

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation Of One Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear

Completed NA Results posted Last updated 19 October 2020

What this trial tests

NA trial testing fanfilcon A test lens in Myopia in 114 participants. Completed in 8 November 2019.

Timeline

9 June 2019

Primary endpoint
24 September 2019

8 November 2019

Quick facts

Lead sponsor	CooperVision, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	114
Start date	9 June 2019
Primary completion	24 September 2019
Estimated completion	8 November 2019
Sites	6 locations across United States

Drugs / interventions tested

fanfilcon A test lens
ocufilcon D control lens
etafilcon A control lens

Conditions studied

Myopia — all drugs for Myopia →

Sponsor

CooperVision, Inc.

Who can join

18 and older, 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.

Subjective Overall Comfort Rating Primary · Two weeks

Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses

Group	Value	95% CI
Ocufilcon D - Group A	8.2	± 2.04
Fanfilcon A - Group A	8.6	± 1.19
Etafilcon A - Group B	8.3	± 1.72
Fanfilcon A - Group B	8.3	± 1.64

Subjective Overall Comfort Rating Primary · Four weeks

Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses

Group	Value	95% CI
Ocufilcon D - Group A	7.9	± 2.10
Fanfilcon A - Group A	8.6	± 1.26

Average Wearing Time Secondary · Two weeks

Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes

Group	Value	95% CI
Ocufilcon D - Group A	14.01	± 1.689
Fanfilcon A - Group A	14.7	± 1.674
Etafilcon A - Group B	13.84	± 1.756
Fanfilcon A - Group B	13.80	± 1.757

Average Wearing Time Secondary · Four weeks

Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes

Group	Value	95% CI
Ocufilcon D - Group A	14.21	± 1.501
Fanfilcon A - Group A	14.42	± 1.504

Average Comfortable Wearing Time Secondary · Two weeks

Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes.

Group	Value	95% CI
Ocufilcon D - Group A	11.60	± 3.743
Fanfilcon A - Group A	12.45	± 3.669
Etafilcon A - Group B	12.18	± 3.210
Fanfilcon A - Group B	11.67	± 3.330

Average Comfortable Wearing Time Secondary · Four weeks

Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes.

Group	Value	95% CI
Ocufilcon D - Group A	11.37	± 3.869
Fanfilcon A - Group A	12.40	± 3.379

Lens Centration Secondary · Baseline (after 15 minutes)

Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (\>0.5mm)).

Optimal

Group	Value	95% CI
Ocufilcon D - Group A	85
Fanfilcon A - Group A	93
Etafilcon A - Group B	91
Fanfilcon A - Group B	94

Slight

Group	Value	95% CI
Ocufilcon D - Group A	15
Fanfilcon A - Group A	7
Etafilcon A - Group B	9
Fanfilcon A - Group B	6

Substantial

Group	Value	95% CI
Ocufilcon D - Group A	0
Fanfilcon A - Group A	0
Etafilcon A - Group B	0
Fanfilcon A - Group B	0

Lens Centration Secondary · Two weeks

Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (\>0.5mm)).

Optimal

Group	Value	95% CI
Ocufilcon D - Group A	88
Fanfilcon A - Group A	93
Etafilcon A - Group B	83
Fanfilcon A - Group B	95

Slight

Group	Value	95% CI
Ocufilcon D - Group A	12
Fanfilcon A - Group A	7
Etafilcon A - Group B	17
Fanfilcon A - Group B	5

Substantial

Group	Value	95% CI
Ocufilcon D - Group A	0
Fanfilcon A - Group A	0
Etafilcon A - Group B	0
Fanfilcon A - Group B	0

Lens Centration Secondary · Four weeks

Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (\>0.5mm)).

Optimal

Group	Value	95% CI
Ocufilcon D - Group A	86
Fanfilcon A - Group A	89

Slight

Group	Value	95% CI
Ocufilcon D - Group A	14
Fanfilcon A - Group A	11

Substantial

Group	Value	95% CI
Ocufilcon D - Group A	0
Fanfilcon A - Group A	0

Corneal Coverage Secondary · Baseline (after 15 minutes of lens dispense)

Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)

yes

Group	Value	95% CI
Ocufilcon D - Group A	100
Fanfilcon A - Group A	100
Etafilcon A - Group B	100
Fanfilcon A - Group B	100

Group	Value	95% CI
Ocufilcon D - Group A	0
Fanfilcon A - Group A	0
Etafilcon A - Group B	0
Fanfilcon A - Group B	0

Corneal Coverage Secondary · Two weeks

Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)

yes

Group	Value	95% CI
Ocufilcon D - Group A	98
Fanfilcon A - Group A	98
Etafilcon A - Group B	100
Fanfilcon A - Group B	100

Group	Value	95% CI
Ocufilcon D - Group A	2
Fanfilcon A - Group A	2
Etafilcon A - Group B	0
Fanfilcon A - Group B	0

Corneal Coverage Secondary · Four weeks

Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)

yes

Group	Value	95% CI
Ocufilcon D - Group A	100
Fanfilcon A - Group A	98

Group	Value	95% CI
Ocufilcon D - Group A	0
Fanfilcon A - Group A	2

Adverse events — posted to ClinicalTrials.gov

Time frame: From dispense up to 4 weeks for ocufilcon D and fanfilcon A - Group A, from dispense up to 2 weeks for etafilcon A and fanfilcon A - Group B. A total of 8 weeks. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ocufilcon D - Group A

Serious: 0/58 (0%)

Deaths: 0/58

Fanfilcon A - Group A

Serious: 0/57 (0%)

Deaths: 0/57

Etafilcon A - Group B

Serious: 0/56 (0%)

Deaths: 0/56

Fanfilcon A - Group B

Serious: 0/56 (0%)

Deaths: 0/56

Other adverse events (1 terms — click to expand)

Reaction	System	Ocufilcon D - Group A	Fanfilcon A - Group A	Etafilcon A - Group B	Fanfilcon A - Group B
headache	General disorders	—	—	—	—

Data from ClinicalTrials.gov NCT04050618 adverse events section.

Sponsor's own description

To evaluate the comparative clinical performance of the fanfilcon A silicone hydrogel lens used in daily wear and to compare this with competitive hydrogel lens products.

Publications & conference data

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

Verify or expand the search:

Other recruiting trials for Myopia

Currently open trials in the same condition.

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NCT07354945 — An Evaluation of Myopia Control Lenses on Wearing Experience in Myopic Children · NA · recruiting
NCT07229365 — Children's Viewing Behavior · NA · recruiting

Other CooperVision, Inc. trials

Trials by the same sponsor.

NCT06817785 — Soft Lens Study: Biomedics 1 Day Extra Sphere and Clariti 1 Day Sphere · NA · completed
NCT06758076 — A Clinical Comparison of Two Soft Contact Lenses (C24-755) · NA · completed
NCT06590441 — Investigation of Wearing Compliance of Spectacles for Myopia Control · completed
NCT06609018 — Clinical Investigation of Buttermere (LENS 271) Soft Contact Lenses · NA · completed
NCT06611410 — 1 Week Crossover Study Between Two Soft Contact Lenses · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04050618 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by CooperVision, Inc.
Last refreshed: 19 October 2020

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/NCT04050618.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04050618

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Myopia

Other CooperVision, Inc. trials

Verify against primary sources