NCT01094743 is a NA clinical trial of galyfilcon A prototype lens in Myopia, sponsored by Johnson & Johnson Vision Care, Inc..

Who is sponsoring NCT01094743?

NCT01094743 is sponsored by Johnson & Johnson Vision Care, Inc..

What drugs are being tested in NCT01094743?

Interventions in NCT01094743: galyfilcon A prototype lens, lotrafilcon B lens.

Is NCT01094743 still recruiting?

NCT01094743 is currently completed. Last updated 19 June 2018.

Are results published for NCT01094743?

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

NCT01094743

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

Dispensing Evaluation of a Prototype Contact 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 52 participants. Completed in 1 March 2010.

Timeline

1 February 2010

Primary endpoint
1 March 2010

1 March 2010

Quick facts

Lead sponsor	Johnson & Johnson Vision Care, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	52
Start date	1 February 2010
Primary completion	1 March 2010
Estimated completion	1 March 2010
Sites	2 locations across United States

Drugs / interventions tested

galyfilcon A prototype lens
lotrafilcon B lens

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 1 week of lens wear

Snellen monocular visual acuity measurement

20/15 monocular

Group	Value	95% CI
Galyfilcon A Prototype	59
Lotrafilcon B	64

20/20 monocular

Group	Value	95% CI
Galyfilcon A Prototype	40
Lotrafilcon B	30

20/25 monocular

Group	Value	95% CI
Galyfilcon A Prototype	1
Lotrafilcon B	5

20/30 monocular

Group	Value	95% CI
Galyfilcon A Prototype	0
Lotrafilcon B	1

Visual Acuity Binocular Primary · after 1 week of lens wear

Snellen binocular visual acuity measurement

20/15 binocular

Group	Value	95% CI
Galyfilcon A Prototype	40
Lotrafilcon B	42

20/20 binocular

Group	Value	95% CI
Galyfilcon A Prototype	10
Lotrafilcon B	8

Subjective Assessment of Lens Comfort Primary · after 1 week 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
Galyfilcon A Prototype	66.23	± 24.112
Lotrafilcon B	55	± 21.844

Limbal Redness Secondary · after 1 week of lens wear

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

Grade 0 None

Group	Value	95% CI
Galyfilcon A Prototype	37
Lotrafilcon B	35

Grade 1 Trace

Group	Value	95% CI
Galyfilcon A Prototype	61
Lotrafilcon B	61

Grade 2 Mild

Group	Value	95% CI
Galyfilcon A Prototype	2
Lotrafilcon B	4

Bulbar Redness Secondary · after 1 week of lens wear

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

Grade 0 None

Group	Value	95% CI
Galyfilcon A Prototype	44
Lotrafilcon B	34

Grade 1 Trace

Group	Value	95% CI
Galyfilcon A Prototype	50
Lotrafilcon B	64

Grade 2 Mild

Group	Value	95% CI
Galyfilcon A Prototype	6
Lotrafilcon B	2

Subjective Assessment of Quality of Vision Primary · after 1 week of lens wear

Group	Value	95% CI
Galyfilcon A Prototype	63.22	± 25.345
Lotrafilcon B	59.83	± 20.036

Subjective Assessment of Lens Comfort Secondary · 10 minutes after lens insertion at time of initial lens fitting

Group	Value	95% CI
Galyfilcon A Prototype	76.67	± 18.487
Lotrafilcon B	65	± 19.842

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.

NCT01180985 — Dispensing Evaluation of a Galyfilcon A Prototype Lens and a Marketed Contact Lens · NA · completed
NCT01094730 — Pilot Evaluation of a New Galyfilcon A Contact Lens Compared to a Marketed Galyfilcon A 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 NCT01094743 (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/NCT01094743.

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