Clinical Performance of a New Daily Disposable Contact Lens Worn in an Established Contact Lens Wearing Population
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Refractive Error
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Upper Lid Margin Staining
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This study seeks to evaluate the clinical and subjective performance of a new daily disposable soft contact lens.
Investigators
Eligibility Criteria
Inclusion Criteria
- •They are of legal age (17 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.
Outcomes
Primary Outcomes
Upper Lid Margin Staining
Time Frame: At 2 weeks and 4 weeks.
Measures the trauma to tissue that lines the margin of the inside of the upper eyelid on a 0 to 3 scale, with 0=none to 3=severe. The analysis is the average grade over all time frames.
Limbal Hyperemia
Time Frame: At 2 weeks and 4 weeks
Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe. The analysis is the average grade over all time frames.
Lens Comfort
Time Frame: At 3,7,10,13,17,21,24, and 27 days
Rating of lens comfort by rating agreement to the following statement: "The lenses I am wearing are comfortable." Rating using the following scale: 1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree. The rating is averaged over all time frames.
Secondary Outcomes
- Corneal Staining(At 2 weeks and 4 weeks.)
- Tarsal Hyperemia(At 2 weeks and 4 weeks.)
- Tarsal Roughness(At 2 weeks and 4 weeks)