Prospective Study of an Investigational… | Clinical Trial

Key information

Conditions

Myopia Eye Diseases Refractive Errors

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

Subjects with normal eyes who are not using any ocular medications.
Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
Willing and able to wear spherical contact lenses for at least 5 days per week.
Willing and able to wear spherical contact lenses within the available range of powers of -1.00 diopter(D) to -6.00D in 0.25D steps.
Best spectacle-corrected visual acuity greater than or equal to 20/25.
Manifest cylinder less than or equal to 0.75D.
Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Any active anterior segment ocular disease that would contraindicate contact lens wear.
Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
History of refractive surgery or irregular cornea.
History of pathologically dry eye.
Eye injury within twelve weeks immediately prior to enrollment for this trial.
Currently enrolled in any clinical trial.
Participation in a contact lens or contact lens care product clinical trial within the previous 30 days.
Other protocol-defined exclusion criteria may apply.

Treatment and study plan

delefilcon A contact lens

Device

Investigational silicone hydrogel, single vision soft contact lens

Narafilcon B Contact Lens

Device

Commercially marketed silicone hydrogel, single vision soft contact lens

Primary outcomes

Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity

Time frame: 3 months of wear, lenses replaced daily

Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better.

Secondary outcomes

Overall Vision

Time frame: 3 months of wear, lenses replaced daily

As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Comfort

Time frame: 3 months of wear, lenses replaced daily

As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Handling

Time frame: 3 months of wear, lenses replaced daily

As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Registry information

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Feb 15, 2011
Registry last updated: Jul 10, 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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Completed