NCT00708032CompletedNot Applicable
Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.
Johnson & Johnson Vision Care, Inc.2 sites in 1 country74 target enrollmentStarted: June 1, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 74
- Locations
- 2
- Primary Endpoint
- Papillary Conjunctivitis
Study Overview
Brief Summary
This study seeks to evaluate the impact of wearing a new daily disposable soft contact lens on the neophyte population.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 39 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •They are of legal age (18 years) and capacity to volunteer.
- •They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
- •They are willing and able to follow the protocol.
- •They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
- •They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
- •They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
- •They have successfully worn contact lenses within six months of starting the study.
Exclusion Criteria
- •They have an ocular disorder which would normally contra-indicate contact lens wear.
- •They have a systemic disorder which would normally contra-indicate contact lens wear.
- •They are using any topical medication such as eye drops or ointment.
- •They are aphakic.
- •They have had corneal refractive surgery.
- •They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
- •They are pregnant or lactating.
- •They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
- •They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
- •They have diabetes.
- •They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Outcomes
Primary Outcomes
Papillary Conjunctivitis
Time Frame: 12 months
Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns.
Secondary Outcomes
- Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis.(at 12 months)
- Visual Acuity After 12 Months of Wear(at 12 months)
- Subjective Overall Comfort After 12 Months of Daily Wear(at 12 months)
- Subjective Overall Vision After 12 Months of Daily Wear(at 12 months)
Investigators
Study Sites (2)
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