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The Clinical Evaluation of Two Daily Disposable Contact Lenses

Johnson & Johnson (J&J) logo

Johnson & Johnson (J&J)

Status

Completed

Conditions

Myopia

Treatments

Device: etafilcon A
Device: omafilcon A

Study type

Interventional

Funder types

Industry

Identifiers

NCT00762996
CR-0707

Details and patient eligibility

About

The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.

Enrollment

65 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • They are of legal age (18 years) and capacity to volunteer.
  • They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
  • They are willing and able to follow the protocol.
  • They would be expected to attain at least 6.9 (20/30) in each eye with the study lenses.
  • They are able to wear contact lenses which have a back vertex power of -1.00 to -6.00DS.
  • They have a maximum of 1.00D of refractive astigmatism (i.e. < 1.00 DC).
  • They have worn soft contact lenses within six months of starting the study.

Exclusion criteria

  • They have an ocular disorder which would normally contra-indicate contact lens wear.
  • They have a systemic disorder which would normally contra-indicate contact lens wear.
  • They are using any topical medication such as eye drops or ointment.
  • They are aphakic.
  • They have had corneal refractive surgery.
  • They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
  • They are pregnant or lactating.
  • They have grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
  • They have any infectious disease (e.g., hepatitis) or any immunosuppressive disease (e.g., HIV).
  • They have diabetes.
  • They are currently taking part in any other clinical study or research.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

65 participants in 4 patient groups

etafilcon A/etafilcon A
Active Comparator group
Description:
Period 1: etafilcon A, Period 2: etafilcon A
Treatment:
Device: etafilcon A
etafilcon A/omafilcon A
Active Comparator group
Description:
Period 1: etafilcon A, Period 2: omafilcon A
Treatment:
Device: etafilcon A
Device: omafilcon A
omafilcon A/etafilcon A
Active Comparator group
Description:
Period 1: omafilcon A, Period 2: etafilcon A
Treatment:
Device: etafilcon A
Device: omafilcon A
omafilcon A/omafilcon A
Active Comparator group
Description:
Period 1: omafilcon A, Period 2: omafilcon A
Treatment:
Device: omafilcon A

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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