A Comparative Study of Two Daily Disposable Contact Lenses in Higher Myopia Subjects



Status:Completed
Conditions:Ocular, Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:March 2014
End Date:May 2014
Contact:Alcon Call Center
Email:alcon.medinfo@alcon.com
Phone:1-888-451-3937

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The purpose of this study is to compare the central corneal curvature in highly myopic
participants wearing two different silicone hydrogel contact lenses, one in each eye, for
one week.

Participants will be expected to attend 4 office visits. Visit 1 is the Screening/Enrollment
visit. Between Visit 1 and Visit 2 (Baseline visit), participants will be allowed to wear
their habitual contact lenses, except for the last two days prior to Visit 2. At Visit 2,
participants will be randomized and the study lenses will be trial fit. Spectacle lenses
will be ordered (if necessary) to ensure acceptable visual acuity during study lens wear.
Between Visit 2 and Visit 3 (Dispensing visit) participants may wear their habitual contact
lenses, except for the last two days prior to the Visit 3. At Visit 3, participants will
receive study lenses and the spectacles, if needed, for 1 week of wear. Visit 4 (Follow
up/Exit visit) will occur 1 week later. The expected duration of participation in the study
is about 3 weeks.

Inclusion Criteria:

- Sign Informed Consent document;

- Higher degree of myopia in both eyes, i.e. habitual contact lens power between -10.00
diopters (D) and -17.00D;

- Best corrected distance visual acuity greater than or equal to 20/30 in each eye
(measured with either spectacle refraction or habitual contact lenses plus over
refraction);

- Manifest astigmatism less than or equal to -1.00D;

- Soft contact lens wear in both eyes at least 5 days per week and at least 8 hours per
day;

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Pregnant or lactating;

- Eye injury or surgery within twelve weeks immediately prior to enrollment;

- Any ocular condition that contraindicates contact lens wear;

- History of herpetic keratitis;

- Any use of systemic or ocular medications for which contact lens wear could be
contraindicated, including any use of topical ocular medications that would require
instillation during contact lens wear, except for approved lubricating drops;

- Clinical significant dry eye not responding to treatment;

- Previous corneal or refractive surgery or irregular cornea;

- Requires reading glasses;

- Participation in a clinical trial (including contact lens or contact lens care
product) within the previous 30 days;

- Wears habitual lenses in an extended wear modality (routinely sleeps in lenses
overnight for 1 night per week or more) over the last 3 months prior to enrollment;

- Other protocol-defined exclusion criteria may apply.
We found this trial at
1
site
6201 South Freeway
Fort Worth, Texas 76134
800 862 5266
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