Singapore
NCT Number: NCT01163760
Clinical Evaluation of Two Daily Disposable Contact Lenses
This study seeks to evaluate the clinical performance of two daily disposable contact lenses.
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Notify MeKey information
Conditions
Age range
21 year–39 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Be between 21 and 39 years of age.
- Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
- Be existing (i.e. successfully worn for 1-month prior to the study) soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
- Require a visual correction in both eyes (monovision allowed but no monofit).
- Have a contact lens spherical distance requirement between -1.00D and -6.00D in both eyes.
- Astigmatism of 1.00D or less in both eyes.
- Be able to wear the lens powers available for this study.
- Be correctable to a visual acuity of 20/30 or better in each eye.
- Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- No amblyopia.
- No evidence of lid abnormality or infection.
- No conjunctival abnormality or infection.
- No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularisation, infiltrates or abnormal opacities).
- No other active ocular disease.
Exclusion criteria
- Requires concurrent ocular medication.
- Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- Clinically significant (Grade 3 or 4) corneal edema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
- Diabetic.
- Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
- Extended lens wear in last 3 months.
- PMMA or RGP lens wear in the previous 8 weeks.
- Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
- Abnormal lacrimal secretions.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Keratoconus or other corneal irregularity.
- Pregnancy, lactating or planning a pregnancy at the time of enrollment.
- Participation in any concurrent clinical trial or in last 60 days."
Treatment and study plan
etafilcon A
Devicedaily disposable contact lens
ocufilcon D
Devicedaily disposable contact lens
Primary outcomes
-
Lens Comfort
Time frame: 1-week follow-up
Lens comfort was evaluated via the subjective question: "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" (excellent/very good=5...very good=3...Poor=0)
Secondary outcomes
-
Comfort Throughout the Whole Day
Time frame: 1-week follow-up
Comfort throughout the day was evaluated via subjective question: "Comfort throughout the whole day" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".
Other outcomes
-
Comfort While Working on Computer
Time frame: 1-week-follow-up
Comfort throughout the day was evaluated via subjective question: "Comfort while working on computer" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".
Sponsors and collaborators
Lead sponsor
Johnson & Johnson Vision Care, Inc.
Industry
Collaborators
- Singapore Polytechnic University
- Visioncare Research Ltd.
Registry information
Important dates
- Study start
- 2007
- Primary completion
- 2007
- Study completion
- 2007
- First posted
- Jul 16, 2010
- Registry last updated
- Jun 19, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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