NCT00808340 is a NA clinical trial of balafilcon A in Presbyopia, sponsored by Johnson & Johnson Vision Care, Inc..

Who is sponsoring NCT00808340?

NCT00808340 is sponsored by Johnson & Johnson Vision Care, Inc..

What drugs are being tested in NCT00808340?

Interventions in NCT00808340: balafilcon A, senofilcon A production, senofilcon A test.

What condition does NCT00808340 study?

NCT00808340 studies Presbyopia.

Is NCT00808340 still recruiting?

NCT00808340 is currently completed. Last updated 19 June 2018.

Are results published for NCT00808340?

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

NCT00808340

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

Comparison of Three Soft Bifocal Contact Lenses

Completed NA Results posted Last updated 19 June 2018

What this trial tests

NA trial testing balafilcon A in Presbyopia in 37 participants. Completed in 1 December 2008.

Timeline

1 November 2008

Primary endpoint
1 December 2008

1 December 2008

Quick facts

Lead sponsor	Johnson & Johnson Vision Care, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	37
Start date	1 November 2008
Primary completion	1 December 2008
Estimated completion	1 December 2008
Sites	1 location across United States

Drugs / interventions tested

balafilcon A — full drug profile →
senofilcon A production
senofilcon A test

Conditions studied

Presbyopia — all drugs for Presbyopia →

Sponsor

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

Who can join

Adults 35 to 70, any sex, with Presbyopia. 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.

Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity Primary · 5 minutes after insertion

Tested with both eyes together in bright lighting, reading charts distant to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.

Group	Value	95% CI
Senofilcon A Test	0.8191	± 0.161
Senofilcon A Prod	0.6942	± 0.161
Balafilcon A	1.0635	± 0.161

Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity Primary · 5 minutes after insertion

Tested with both eyes together in bright lighting reading charts near to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.

Group	Value	95% CI
Senofilcon A Test	-0.6735	± 0.161
Senofilcon A Prod	-0.6327	± 0.161
Balafilcon A	-0.1719	± 0.161

Type of Corneal Staining Primary · after 1 week of lens wear, for each lens type

Investigator rated type of corneal staining as either 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced, or 4=patch(\> or = to mm).

Group	Value	95% CI
Senofilcon A Test	0.1311	± 0.07154
Senofilcon A Prod	0.1017	± 0.07154
Balafilcon A	0.1694	± 0.07154

Overall Subjective Vision Primary · after 1 week of lens wear, for each lens type

Subject rated the overall quality of vision with the study contact lenses. 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

Group	Value	95% CI
Senofilcon A Test	3.5373	± 0.1681
Senofilcon A Prod	3.207	± 0.1681
Balafilcon A	3.4351	± 0.1681

Sponsor's own description

The primary purpose of the study is to compare the performance of three soft bifocal contact lenses in terms of the vision provided by the 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 trials of balafilcon A

Trials testing the same drug.

NCT00912028 — Clinical Performance Comparison of Several Different Contact Lenses · NA · completed

Other recruiting trials for Presbyopia

Currently open trials in the same condition.

NCT07444658 — Performance of Two Daily Disposable Multifocal Contact Lenses · NA · recruiting
NCT07284966 — Comfort and Vision With TOTAL30 Multifocal Lenses · recruiting
NCT07077967 — Luminous Efficiency Function V(λ)' of Patients That Underwent Pseudophakic Presbyopic Corrections With EDOF IOLs · recruiting
NCT07113210 — Quality of Life in Presbyopic Patients Who Are Treated With Qlosi · Phase 4 · recruiting
NCT06948357 — Efficacy and Safety of BRIMOCHOL PF and CARBACHOL PF in Chinese Presbyopia Patients · Phase 2 · 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 NCT00808340 (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/NCT00808340.

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