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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01362907
Other study ID # P-347-C-013
Secondary ID
Status Completed
Phase N/A
First received May 27, 2011
Last updated June 28, 2012
Start date May 2011
Est. completion date June 2011

Study information

Verified date June 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 trial was to compare the performance of an investigational daily disposable contact lens to a commercially available daily disposable contact lens.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Normal eyes with no use of 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 protocol-specified timeframe within the available range of powers (-1.00 D to -6.00D in 0.25D steps).

- Visual acuity with study lenses 20/25 or better.

- Cylinder less than or equal to 0.75 D.

- Currently wearing daily disposable lenses.

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Anterior segment infection, inflammation, or abnormality.

- 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.

- Eye injury within twelve weeks immediately prior to enrollment for this trial.

- Currently enrolled in any clinical trial.

- Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Delefilcon A contact lens
Investigational, silicone hydrogel, single vision, soft contact lens for daily disposable wear
Etafilcon A contact lens
Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear

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 Reported as Visual Acuity (VA) As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity. 1 week of wear, replacing lenses daily No
Primary Overall Comfort As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. 1 week of wear, replacing lenses daily No
Primary Overall Vision Quality As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. 1 week of wear, replacing lenses daily No
Primary Overall Handling As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy. 1 week of wear, replacing lenses daily No
Secondary Overall Lens Fit As assessed for each eye individually by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit is reported on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. 1 week of wear, replacing lenses daily No
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