Who is sponsoring NCT04658797?

NCT04658797 is sponsored by CooperVision, Inc..

What drugs are being tested in NCT04658797?

Interventions in NCT04658797: somofilcon A Daily Disposable Contact Lens, Single Vision Spectacle for Vision Correction, Personal Facemask.

Is NCT04658797 still recruiting?

NCT04658797 is currently completed. Last updated 20 October 2021.

Are results published for NCT04658797?

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

Last reviewed 2021-10-20 · How we verify

NCT04658797

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

Clinical Evaluation on Using Personal Face Masks With Spectacles Versus Contact Lenses

Completed NA Results posted Last updated 20 October 2021

What this trial tests

NA trial testing somofilcon A Daily Disposable Contact Lens in Myopia in 30 participants. Completed in 30 April 2021.

Timeline

1 November 2020

Primary endpoint
15 April 2021

30 April 2021

Quick facts

Lead sponsor	CooperVision, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 November 2020
Primary completion	15 April 2021
Estimated completion	30 April 2021
Sites	1 location across United Kingdom

Drugs / interventions tested

somofilcon A Daily Disposable Contact Lens
Single Vision Spectacle for Vision Correction
Personal Facemask

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.

Visual Acuity - High Contrast Primary · Baseline

Visual Acuity under high contrast was measured using logMAR Visual Acuity Chart

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	-0.06	± 0.07
Single Vision Spectacle for Vision Correction	-0.07	± 0.05

Visual Acuity - Low Contrast Primary · Baseline

Visual Acuity under low contrast was measured using logMAR Visual Acuity Chart

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	0.20	± 0.10
Single Vision Spectacle for Vision Correction	0.21	± 0.07

Visual Acuity - High Contrast Primary · 2 weeks

Visual Acuity under high contrast was measured using logMAR Visual Acuity Chart

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	-0.08	± 0.08
Single Vision Spectacle for Vision Correction	-0.08	± 0.05

Subjective Response on Facemask Usability Questionnaire - Breathability Primary · Baseline

Subjective response on facemask usability questionnaire - Breathability assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)

Very Satisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	1
Single Vision Spectacle for Vision Correction	2

Satisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	4
Single Vision Spectacle for Vision Correction	5

Average

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	5
Single Vision Spectacle for Vision Correction	6

Unsatisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	4
Single Vision Spectacle for Vision Correction	2

very unsatisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	1
Single Vision Spectacle for Vision Correction	0

Subjective Response on Facemask Usability Questionnaire - Breathability Primary · 2 weeks

Subjective response on facemask usability questionnaire - Breathability assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)

Very Satisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	5
Single Vision Spectacle for Vision Correction	1

Satisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	5
Single Vision Spectacle for Vision Correction	5

Average

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	5
Single Vision Spectacle for Vision Correction	6

Unsatisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	0
Single Vision Spectacle for Vision Correction	2

very unsatisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	0
Single Vision Spectacle for Vision Correction	1

Subjective Response on Facemask Usability Questionnaire - Heat Primary · Baseline

Subjective response on facemask usability questionnaire - Heat assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)

Very Satisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	1
Single Vision Spectacle for Vision Correction	0

Satisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	2
Single Vision Spectacle for Vision Correction	6

Average

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	3
Single Vision Spectacle for Vision Correction	4

Unsatisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	8
Single Vision Spectacle for Vision Correction	4

very unsatisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	1
Single Vision Spectacle for Vision Correction	1

Subjective Response on Facemask Usability Questionnaire -Heat Primary · 2 weeks

Subjective response on facemask usability questionnaire - Heat assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)

Very Satisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	3
Single Vision Spectacle for Vision Correction	1

Satisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	6
Single Vision Spectacle for Vision Correction	2

Average

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	4
Single Vision Spectacle for Vision Correction	4

Unsatisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	2
Single Vision Spectacle for Vision Correction	7

very unsatisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	0
Single Vision Spectacle for Vision Correction	1

Subjective Response on Facemask Usability Questionnaire - Tightness Primary · Baseline

Subjective response on facemask usability questionnaire - Tightness assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)

Very satisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	2
Single Vision Spectacle for Vision Correction	2

Satisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	7
Single Vision Spectacle for Vision Correction	7

Average

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	4
Single Vision Spectacle for Vision Correction	5

Unsatisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	2
Single Vision Spectacle for Vision Correction	1

Very unsatisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	0
Single Vision Spectacle for Vision Correction	0

Subjective Response on Facemask Usability Questionnaire -Tightness Primary · 2 weeks

Subjective response on facemask usability questionnaire - Tightness assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)

Very satisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	4
Single Vision Spectacle for Vision Correction	0

Satisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	7
Single Vision Spectacle for Vision Correction	10

Average

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	3
Single Vision Spectacle for Vision Correction	5

Unsatisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	1
Single Vision Spectacle for Vision Correction	0

Very unsatisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	0
Single Vision Spectacle for Vision Correction	0

Subjective Response on Facemask Usability Questionnaire - Ease in Talking Primary · Baseline

Subjective response on facemask usability questionnaire - Ease in Talking assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)

Very satisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	2
Single Vision Spectacle for Vision Correction	1

Satisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	3
Single Vision Spectacle for Vision Correction	6

Average

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	4
Single Vision Spectacle for Vision Correction	5

Unsatisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	5
Single Vision Spectacle for Vision Correction	3

Very unsatisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	1
Single Vision Spectacle for Vision Correction	0

Subjective Response on Facemask Usability Questionnaire -Ease in Talking Primary · 2 weeks

Subjective response on facemask usability questionnaire - Ease in Talking assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)

Very satisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	3
Single Vision Spectacle for Vision Correction	1

Satisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	4
Single Vision Spectacle for Vision Correction	4

Average

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	4
Single Vision Spectacle for Vision Correction	6

Unsatisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	4
Single Vision Spectacle for Vision Correction	4

Very unsatisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	0
Single Vision Spectacle for Vision Correction	0

Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes Primary · Baseline

Subjective response on facemask usability questionnaire - Comfort on ear lobes assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)

Very satisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	8
Single Vision Spectacle for Vision Correction	3

Satisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	2
Single Vision Spectacle for Vision Correction	7

Average

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	1
Single Vision Spectacle for Vision Correction	2

Unsatisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	3
Single Vision Spectacle for Vision Correction	3

Very unsatisfactory

Group	Value	95% CI
Somofilcon A Daily Disposable Contact Lenses	1
Single Vision Spectacle for Vision Correction	0

Sponsor's own description

The aim of this study was to explore satisfaction with vision correction and ease of use of PFM (Personal Face Masks) in a group of spectacle wearers who were randomised to continue wearing spectacles or be fitted with daily disposable contact lenses.

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.

NCT07284966 — Comfort and Vision With TOTAL30 Multifocal Lenses · recruiting
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NCT07585877 — Effect of Branched-Chain Amino Acid Supplementation on Myopia Progression · NA · active not recruiting
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 NCT04658797 (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: 20 October 2021

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/NCT04658797.

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

NCT04658797

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — 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