NCT01180985 is a NA clinical trial of galyfilcon A prototype lens in Myopia, sponsored by Johnson & Johnson Vision Care, Inc..

Who is sponsoring NCT01180985?

NCT01180985 is sponsored by Johnson & Johnson Vision Care, Inc..

What drugs are being tested in NCT01180985?

Interventions in NCT01180985: galyfilcon A prototype lens, comfilcon A.

Is NCT01180985 still recruiting?

NCT01180985 is currently completed. Last updated 19 June 2018.

Are results published for NCT01180985?

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

Last reviewed 2018-06-19 · How we verify

NCT01180985

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

Dispensing Evaluation of a Galyfilcon A Prototype Lens and a Marketed Contact Lens

Completed NA Results posted Last updated 19 June 2018

What this trial tests

NA trial testing galyfilcon A prototype lens in Myopia in 53 participants. Completed in 1 July 2010.

Timeline

1 June 2010

Primary endpoint
1 July 2010

1 July 2010

Quick facts

Lead sponsor	Johnson & Johnson Vision Care, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	53
Start date	1 June 2010
Primary completion	1 July 2010
Estimated completion	1 July 2010
Sites	4 locations across United States

Drugs / interventions tested

galyfilcon A prototype lens
comfilcon A — full drug profile →

Conditions studied

Myopia — all drugs for Myopia →

Sponsor

Johnson & Johnson Vision Care, Inc. — full company profile →

Who can join

Adults 18 to 39, 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 Monocular Primary · after 7 +/- 1 days of lens wear

Snellen monocular visual acuity measurement was measured in both eyes that wore lenses for one week and came in for the evaluation with an inserted lens.

20/15 monocular

Group	Value	95% CI
Comfilcon A Lens (Control)	53
Galyfilcon A Lens (Test)	49

20/20 monocular

Group	Value	95% CI
Comfilcon A Lens (Control)	49
Galyfilcon A Lens (Test)	48

20/25 monocular

Group	Value	95% CI
Comfilcon A Lens (Control)	2
Galyfilcon A Lens (Test)	4

20/30 monocular

Group	Value	95% CI
Comfilcon A Lens (Control)	0
Galyfilcon A Lens (Test)	3

Visual Acuity Binocular Primary · after 7 +/- 1 days of lens wear

Snellen binocular visual acuity measurement

20/10 binocular

Group	Value	95% CI
Comfilcon A Lens (Control)	0
Galyfilcon A Lens (Test)	1

20/15 binocular

Group	Value	95% CI
Comfilcon A Lens (Control)	31
Galyfilcon A Lens (Test)	29

20/20 binocular

Group	Value	95% CI
Comfilcon A Lens (Control)	21
Galyfilcon A Lens (Test)	20

20/25 binocular

Group	Value	95% CI
Comfilcon A Lens (Control)	0
Galyfilcon A Lens (Test)	1

20/30 binocular

Group	Value	95% CI
Comfilcon A Lens (Control)	0
Galyfilcon A Lens (Test)	1

Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire. Primary · after 7 +/-1 days of lens wear

The contract Lens Experience (CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.

Group	Value	95% CI
Comfilcon A Lens (Control)	57.72	± 4.47
Galyfilcon A Lens (Test)	67.06	± 4.50

Limbal Redness Secondary · after 7 days of lens wear

Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.

Grade 0 = No redness

Group	Value	95% CI
Comfilcon A Lens (Control)	37
Galyfilcon A Lens (Test)	36

Grade 1 = Trace redness

Group	Value	95% CI
Comfilcon A Lens (Control)	36
Galyfilcon A Lens (Test)	42

Grade 2 = Mild redness

Group	Value	95% CI
Comfilcon A Lens (Control)	31
Galyfilcon A Lens (Test)	26

Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire. Primary · after 7 +/- 1 days of lens wear

Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.

Group	Value	95% CI
Comfilcon A Lens (Control)	62.75	± 2.83
Galyfilcon A Lens (Test)	59.98	± 2.81

Bulbar Redness Secondary · after 7 days of lens wear

Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.

Grade 0 = No redness

Group	Value	95% CI
Comfilcon A Lens (Control)	39
Galyfilcon A Lens (Test)	37

Grade 1 = Trace redness

Group	Value	95% CI
Comfilcon A Lens (Control)	55
Galyfilcon A Lens (Test)	59

Grade 2 = Mild redness

Group	Value	95% CI
Comfilcon A Lens (Control)	10
Galyfilcon A Lens (Test)	8

Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire. Secondary · 10 minutes after lens insertion at time of initial lens fitting

Group	Value	95% CI
Comfilcon A Lens (Control)	80.32	± 18.36
Galyfilcon A Lens (Test)	82.76	± 17.01

Sponsor's own description

The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.

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 trials of galyfilcon A prototype lens

Trials testing the same drug.

NCT01094730 — Pilot Evaluation of a New Galyfilcon A Contact Lens Compared to a Marketed Galyfilcon A Contact Lens · NA · completed
NCT01094743 — Dispensing Evaluation of a Prototype Contact Lens and a Marketed Contact Lens · NA · completed

Other recruiting trials for Myopia

Currently open trials in the same condition.

NCT07284966 — Comfort and Vision With TOTAL30 Multifocal Lenses · recruiting
NCT07078799 — Wavefront-guided LASIK Surgery Compared to Ray Tracing-Guided LASIK Surgery · NA · recruiting
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 Johnson & Johnson Vision Care, Inc. trials

Trials by the same sponsor.

NCT07443215 — Evaluation of Effect of Scatter on Visual Performance · NA · recruiting
NCT07174596 — Evaluation of Approved Contact Lenses · NA · completed
NCT07076160 — Pilot Dispensing Study of Two Marketed Daily Disposable Multifocal Contact Lenses · NA · completed
NCT06967129 — Evaluation of Daily Disposable Toric Soft Lenses Manufactured With an Alternative Hydration Process · NA · completed
NCT06864858 — Clinical Evaluation of Two Cosmetic 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 NCT01180985 (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 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/NCT01180985.

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