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Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks

C

Ciba Vision

Status

Completed

Conditions

Myopia
Astigmatism
Presbyopia

Treatments

Device: lotrafilcon B contact lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT01293240
P-368-C-400

Details and patient eligibility

About

The purpose of this study is to compare the overall performance of a monthly replacement contact lens when worn for one month and when worn for two weeks.

Enrollment

117 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Habitual and successful wearers of contact lenses made of lotrafilcon B material for at least 4 weeks prior to enrollment.
  • Good general health.
  • Sphere requirement in the range +6.00 to -10.00 with astigmatism or multifocal correction or no astigmatism or multifocal correction.
  • Ability to comply with all protocol-mandated procedures and to attend all scheduled office visits.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Anterior segment abnormalities (i.e., cataracts, opacities, etc.) or active anterior segment disease.
  • Administration of any investigational drug or device within 14 days of study initiation.
  • Use of any eye drops with a pharmacological effect within 7 days of Visit 1.
  • Known local or systemic hypersensitivity to contact lens cleaning and disinfecting solutions.
  • Post-refractive surgery.
  • Currently pregnant or lactating by case history.
  • Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

117 participants in 1 patient group

Lotrafilcon B
Experimental group
Treatment:
Device: lotrafilcon B contact lens

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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