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OpenTrials
Completed

NCT Number: NCT00909792

Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products

The objective of this trial is compare the visual performance, ratings, and preference of two multifocal, soft contact lenses.

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be at least 35 years of age
  • Best-corrected distance visual acuity of at least 20/40 in each eye.
  • Spectacle add between +0.75D and +1.50D (inclusive).
  • Able to be fit in available study sphere powers (-1.00 to -5.00D)
  • Currently wearing soft contact lenses at least 5 days a week.
  • Other protocol inclusion/exclusion criteria may apply.

Exclusion criteria

  • Eye injury or surgery within twelve weeks immediately prior to enrollment.
  • Currently enrolled in an ophthalmic clinical trial.
  • Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
  • Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
  • Astigmatism ≥ 1.00D.
  • Currently wearing either of the study products.
  • Other protocol inclusion/exclusion criteria may apply.

Treatment and study plan

lotrafilcon B

Device

Silicone hydrogel, soft, multifocal contact lens

Senofilcon A

Device

Silicone hydrogel, soft, multifocal contact lens

Primary outcomes

  1. Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity

    Time frame: After 1 week of wear

    Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 28, 2009
Registry last updated
Jun 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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