Clinical trial NCT01055132: Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.
Official title: Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the relative performance of a new daily disposable toric soft contact lens against a daily disposable toric contact lens currently available in market, specifically with regards to the comfort and vision with the lens.


Eligibility criteria: Inclusion Criteria:

* The subject must be between 18 and 40 years old.
* The subject must have normal eyes.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
* The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.
* The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00D in each eye.
* The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye.
* The subject's refractive cylinder axis must be 180 degrees plus or minus 30 degrees in each eye.
* The subject must be an adapted wearer of soft toric contact lenses in both eyes.
* The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye.
* Subjects must already possess a wearable pair of spectacles.

Exclusion Criteria:

* Ocular or systemic allergies or disease that may interfere with contact lens wear.
* Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear.
* Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
* Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Pregnancy or lactation
* Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
* Diabetes
* Strabismus

Primary outcomes:
measure: Monocular Visual Acuity on LogMAR Scale
timeFrame: After 5 to 9 days of lens wear
measure: Binocular Visual Acuity on LogMAR Scale
timeFrame: After 5 to 9 days of lens wear
measure: Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire
timeFrame: After 5 to 9 days of lens wear
measure: Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire.
timeFrame: After 5 to 9 days of lens wear
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: New York
country: United States
state: New York
city: Warwick
country: United States
state: Rhode Island
Study officials:
References: