NCT00634101 is a NA clinical trial of nelfilcon A in Refractive Error, sponsored by Johnson & Johnson Vision Care, Inc..

Who is sponsoring NCT00634101?

NCT00634101 is sponsored by Johnson & Johnson Vision Care, Inc..

What drugs are being tested in NCT00634101?

Interventions in NCT00634101: nelfilcon A, narafilcon A.

What condition does NCT00634101 study?

NCT00634101 studies Refractive Error, Myopia.

Is NCT00634101 still recruiting?

NCT00634101 is currently terminated. Last updated 6 January 2021.

Are results published for NCT00634101?

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

Last reviewed 2021-01-06 · How we verify

NCT00634101

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

A Comparison of Two Daily Disposable Contact Lenses

Terminated NA Results posted Last updated 6 January 2021

What this trial tests

NA trial testing nelfilcon A in Refractive Error in 129 participants. Terminated before completion.

Timeline

1 January 2008

Primary endpoint
1 March 2008

1 March 2008

Quick facts

Lead sponsor	Johnson & Johnson Vision Care, Inc.
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	129
Start date	1 January 2008
Primary completion	1 March 2008
Estimated completion	1 March 2008
Sites	20 locations across United Kingdom

Drugs / interventions tested

nelfilcon A — full drug profile →
narafilcon A

Conditions studied

Refractive Error — all drugs for Refractive Error →
Myopia — all drugs for Myopia →

Sponsor

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

Who can join

Adults 18 to 60, any sex, with Refractive Error or 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.

Comfort at the End of the Day Primary · 1-Week Follow-up

Comfort at the end of the day was assessed by the individual questionnaire item "Comfort at the end of the day" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. EOD Comfort was also assessed by the individual item "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" with the respopnse categories of 1=Extremely Uncomfortable, 2=Very Uncomfortable, 3=Slightly Uncomfortable, 4=Comfortable and 5= Very Comfortable. The number of participants that responsed in each cateogry for each item was reported.

Comfort EOD

Group	Value	95% CI
Test (Narafilcon A)	8
Control (Nelfilcon A)	7
Test (Narafilcon A)	17
Control (Nelfilcon A)	12
Test (Narafilcon A)	10
Control (Nelfilcon A)	15
Test (Narafilcon A)	5
Control (Nelfilcon A)	8

Eye Comfort EOD

Group	Value	95% CI
Test (Narafilcon A)	14
Control (Nelfilcon A)	7
Test (Narafilcon A)	13
Control (Nelfilcon A)	16
Test (Narafilcon A)	14
Control (Nelfilcon A)	18
Test (Narafilcon A)	6
Control (Nelfilcon A)	4

Limbal Hyperaemia Primary · 1-Week Follow-up

Limbal Hyperaemia was measured using Efron Grading Scale ranges from 0 to 4 with 0.5 units increments (0 = Normal, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe).

Group	Value	95% CI
Test (Narafilcon A)	72
Control (Nelfilcon A)	54
Test (Narafilcon A)	26
Control (Nelfilcon A)	34
Test (Narafilcon A)	15
Control (Nelfilcon A)	8
Test (Narafilcon A)	0
Control (Nelfilcon A)	8

Overall Handling Secondary · 1-Week Follow-up

Handling was assessed through opinion of handling in the final questionnaire. There were 5 categories Excellent (5), Very Good (4), Good (3), Fair (2) and Poor (1).

Group	Value	95% CI
Test (Narafilcon A)	23
Control (Nelfilcon A)	8
Test (Narafilcon A)	27
Control (Nelfilcon A)	23
Test (Narafilcon A)	8
Control (Nelfilcon A)	18
Test (Narafilcon A)	3
Control (Nelfilcon A)	6

Comfort Immediately When You First Put Them on Primary · 1-Week Follow-up

Comfort immediately when you first put them on was assessed by the individual questionnaire item "Comfort immediately when you first put them on" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.

Group	Value	95% CI
Test (Narafilcon A)	13
Control (Nelfilcon A)	19
Test (Narafilcon A)	22
Control (Nelfilcon A)	13
Test (Narafilcon A)	8
Control (Nelfilcon A)	8
Test (Narafilcon A)	6
Control (Nelfilcon A)	7

Comfort Throughout the Day Primary · 1-Week Follow-up

Comfort throughout the day was assessed by the individual questionnaire item "Comfort throughout the day" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.

Group	Value	95% CI
Test (Narafilcon A)	13
Control (Nelfilcon A)	19
Test (Narafilcon A)	22
Control (Nelfilcon A)	13
Test (Narafilcon A)	8
Control (Nelfilcon A)	8
Test (Narafilcon A)	6
Control (Nelfilcon A)	7

Lack of Dryness at the End of the Day Primary · 1-Week Follow-up

Lack of dryness at the end of the day was assessed by the individual questionnaire item "Not making your eyes feel dry even at the end of the day" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.

Group	Value	95% CI
Test (Narafilcon A)	12
Control (Nelfilcon A)	9
Test (Narafilcon A)	11
Control (Nelfilcon A)	12
Test (Narafilcon A)	9
Control (Nelfilcon A)	8
Test (Narafilcon A)	8
Control (Nelfilcon A)	9

Overall Opinion Primary · 1-Week Follow-up

Overall opinion was assessed by the individual questionnaire item "Considering your experience with the contact lenses you were provided, which statement best describes your overall opinion of these contact lenses? " with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.

Group	Value	95% CI
Test (Narafilcon A)	12
Control (Nelfilcon A)	12
Test (Narafilcon A)	17
Control (Nelfilcon A)	19
Test (Narafilcon A)	10
Control (Nelfilcon A)	9
Test (Narafilcon A)	9
Control (Nelfilcon A)	8

Overall Comfort Primary · 1-Week Follow-up

Overall comfort was assessed by the individual questionnaire item "Overall Comfort" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.

Group	Value	95% CI
Test (Narafilcon A)	12
Control (Nelfilcon A)	14
Test (Narafilcon A)	20
Control (Nelfilcon A)	17
Test (Narafilcon A)	8
Control (Nelfilcon A)	8
Test (Narafilcon A)	6
Control (Nelfilcon A)	7

My Lenses Stayed Moist Primary · 1-Week Follow-up

My Lenses Stayed Moist was assessed by the individual questionnaire item "They stayed moist and smooth, even after long hours at the computer" with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.

Group	Value	95% CI
Test (Narafilcon A)	8
Control (Nelfilcon A)	11
Test (Narafilcon A)	18
Control (Nelfilcon A)	11
Test (Narafilcon A)	8
Control (Nelfilcon A)	10
Test (Narafilcon A)	8
Control (Nelfilcon A)	8

I Forgot i Was Wearing Lenses Was Primary · 1-Week Follow-up

I forgot i was wearing lenses was assessed by the individual questionnaire item "They made me forget that I was wearing contact lenses" with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.

Group	Value	95% CI
Test (Narafilcon A)	12
Control (Nelfilcon A)	16
Test (Narafilcon A)	16
Control (Nelfilcon A)	15
Test (Narafilcon A)	6
Control (Nelfilcon A)	4
Test (Narafilcon A)	13
Control (Nelfilcon A)	8

Mainted Natural Moisture Primary · 1-Week Follow-up

Mainted natural moisture was assessed by the individual questionnaire item "They maintained my eyes' own natural moisture" with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.

Group	Value	95% CI
Test (Narafilcon A)	14
Control (Nelfilcon A)	10
Test (Narafilcon A)	17
Control (Nelfilcon A)	16
Test (Narafilcon A)	7
Control (Nelfilcon A)	10
Test (Narafilcon A)	10
Control (Nelfilcon A)	6

Comfort While Wearing Lenses in Heat/Air Conditioned Environments Primary · 1-Week Follow-up

Comfort while wearing lenses in heat/air conditioned environments was assessed by the individual questionnaire item "How often are you comfortable while sitting under or near an air conditioning vent or heating vent " with the response cateogries 0=Not Applicable, 1=Always, 2=Frequently, 3=Occasionally, 4=Rarely and 5=never. The number of participants that responsed in each cateogry was reported.

Group	Value	95% CI
Test (Narafilcon A)	7
Control (Nelfilcon A)	8
Test (Narafilcon A)	15
Control (Nelfilcon A)	11
Test (Narafilcon A)	16
Control (Nelfilcon A)	12
Test (Narafilcon A)	10
Control (Nelfilcon A)	10

Sponsor's own description

This study seeks to evaluate the clinical performance of a new CE marked daily disposable contact lens that contains a wetting agent to a recently improved daily disposable contact lens.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of nelfilcon A

Trials testing the same drug.

NCT04067141 — The Clinical Comparison of Somofilcon A 1 Day and Nelfilcon A Daily Disposable Contact Lenses · NA · completed
NCT02365298 — Clinical and Laboratory Study of Lysozyme Deposition on Daily Disposable Contact Lenses · NA · completed

Other recruiting trials for Refractive Error

Currently open trials in the same condition.

NCT07354945 — An Evaluation of Myopia Control Lenses on Wearing Experience in Myopic Children · 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 NCT00634101 (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: 6 January 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/NCT00634101.

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