Clinical trial NCT01300065: Evaluation of Two Daily Disposable Contact Lenses.
Official title: A Study to Evaluate the Product Performance of Two Daily Disposable Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: contact lens
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2011-02-21
Enrollment: 441
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this clinical study is to evaluate the product performance of SofLens daily disposable contact lenses packaged in the investigational Test solution versus SofLens daily disposable contact lenses packaged in Control, solution as it relates to comfort when used by subjects who use technology devices (eg, Personal Digital Assistants \[PDAs\], computers, electronic game consoles, hand-held electronic devices, electronic book readers, etc) on an average of 4 hours per day over a week's time for a minimum of 4 days each week.


Eligibility criteria: Inclusion Criteria:

* Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
* Subjects must be free of any anterior segment disorders.
* Subjects must be adapted soft contact lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
* Subjects must be myopic and require contact lens correction from -0.50 D to -6.00 D in each eye.
* Subjects must be willing and able to wear the study lenses for at least 8 hours (12 hours or more is recommended) each day throughout the duration of the study.
* Subjects must use a technologic device for an average of 4 hours per day over a week's time and at a minimum of 4 days per week.

Exclusion Criteria:

* Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
* Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects with an active ocular disease or who are using any ocular medication.
* Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
* Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Subjects with any scar or neovascularization within the central 4 mm of the cornea.
* Subjects who have had any corneal surgery (eg, refractive surgery).
* Subjects who are allergic to any component in the study care products.
* Subjects may not use their habitual rewetting drops while participating in this study.

Primary outcomes:
measure: Percentage of Eyes With > Grade 2 Slit Lamp Findings
timeFrame: 2 weeks
Secondary outcomes:
measure: Initial Lens Performance Survey
timeFrame: At dispensing
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb Incorporated
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Beverly J Barna, CCRA
role: STUDY_DIRECTOR
References: