Prospective Study of an Investigational Daily Disposable Contact Lens

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295905
• Other study ID #: P-347-C-004
• Status: Completed
• Phase: N/A
• First received: February 11, 2011
• Last updated: June 26, 2012
• Start date: January 2011
• Est. completion date: May 2011

Study information

• Verified date: May 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the performance of an investigational daily disposable contact lens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• delefilcon A contact lens
Investigational silicone hydrogel, single vision soft contact lens
• narafilcon B contact lens
Commercially marketed silicone hydrogel, single vision soft contact lens

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity	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.	3 months of wear, lenses replaced daily	No
Secondary	Overall Vision	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.	3 months of wear, lenses replaced daily	No
Secondary	Overall Comfort	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.	3 months of wear, lenses replaced daily	No
Secondary	Overall Handling	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.	3 months of wear, lenses replaced daily	No