Clinical trial NCT01155323: Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses
Official title: Proclear 1 Day Lens vs 1-Day Acuvue Moist Daily Disposable Contact Lens Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson K.K. Medical Company
name: Visioncare Research Ltd.
First posted: 2010-07-01
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study seeks to evaluate and compare the clinical performance of two daily disposable soft contact lenses, Proclear 1 Day and 1-Day Acuvue Moist.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age and no more than 39 years of age
* Existing soft contact lens wearers
* Willing to signed a written Informed Consent.
* Own a mobile phone and are willing to receive and reply to Short Message Service (SMS) messages during the day.
* Have a contact lens spherical distance requirement between -1.00 diopters (D) and -6.00 diopters (D) in both eyes.
* Have an Astigmatism of 1.00D or less in both eyes.
* Require a visual correction in both eyes.
* Be correctable to a visual acuity of 6/9 (20/30) or better in each eye.
* Have normal eyes with no evidence of abnormality or disease that would preclude lens wear.

Exclusion Criteria:

* Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, tarsal abnormalities, bulbar infection, or any other abnormality of the cornea that would contraindicate contact lens wear.
* Clinically significant corneal staining (Grade 3 in more than one region).
* Keratoconus or other corneal irregularity.
* Abnormal lachrymal secretions.
* Extended wear of contact lenses last 3 months.
* Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks.
* Refractive surgery.
* Eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Require concurrent ocular medication
* Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
* Any infectious disease (e.g., hepatitis, tuberculosis) or any immunosuppressive disease (e.g., HIV).
* Diabetes.
* Pregnant, lactating or planning a pregnancy at the time of enrollment.
* Participation in any concurrent clinical trial or in last 30 days.

Primary outcomes:
measure: Subjective Rating of Comfort
timeFrame: after 1 week of lens wear
measure: Vision Quality
timeFrame: after 1 week of lens wear
measure: Subjective Rating of Handling
timeFrame: after 1 week of lens wear
measure: Corneal Staining
timeFrame: after 1 week of lens wear
measure: Subjective Rating of Quality Perceptions
timeFrame: after 1 week of lens wear
measure: Limbal Hyperemia
timeFrame: after 1 week of wear
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore Plytechnic
Study officials:
affiliation: Singapore Polytechnic
name: Danny Sim, Diploma in Optometry
role: PRINCIPAL_INVESTIGATOR
References: