Farnham, GU9 7EN, United Kingdom
NCT Number: NCT01552876
Comparative Clinical Evaluation of Soft Toric Lens Designs
This study is evaluating the initial fit of toric contact lenses.
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Conditions
Age range
18 year and older
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 greater than or equal to 18 years old.
- Read, understand, and sign written Statement of Informed Consent.
- Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Be existing 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 spherical contact lens requirement in the range -0.50D to -6.00D.
- Have astigmatism of between -0.50 and -2.00DC in both eyes.
- Monocular distance visual acuity correctable to 6/9 (0.2 logMAR) or better in each eye with best sphero-cylindrical refraction.
- Have normal eyes with no evidence of any ocular abnormality or disease. For the purposes of this study a normal eye is defined as one having: Clear cornea, No anterior segment disorder, No clinically significant slit lamp findings (i.e. oedema, staining, scarring, vascularisation, infiltrates or abnormal opacities), No other active ocular disease or recent surgery
Exclusion criteria
- Having worn RGP contact lenses within the last 30 days or PMMA contact lenses within the last 3 months.
- Clinically significant corneal oedema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
- Extended lens wear in last 3 months.
- Any systemic or topical medications that will in the investigator's opinion affect ocular physiology or contact lens performance.
- Any systemic disease affecting ocular health.
- Abnormal lacrimal secretions.
- Keratoconus or other corneal irregularity.
- Pregnancy, lactating or planning a pregnancy at the time of enrolment.
- Participation in any concurrent clinical trial.
- Any previous anterior ocular surgery.
- Subjects who are known to have an infectious systemic disease (e.g., hepatitis, tuberculosis).
- Subjects who are known to have an immunosuppressive disease (e.g., HIV positive).
- Subjects who are known to have diabetes.
- Employees or family members of the Research site, Principal Investigator or study team.
Treatment and study plan
etafilcon A
DeviceA daily wear contact lens
Other names: 1-DAY ACUVUE MOIST for Astigmatism
Nelfilcon A
DeviceA daily wear contact lens
Other names: Focus Dailies Toric All Day Comfort
filcon II 3
Devicea daily disposable
Other names: Clariti(TM) 1 day Toric
Primary outcomes
-
Phase I: Absolute Lens Rotation
Time frame: At 1-min after lens insertion during Phase I
At 1-min after lens insertion, lens orientation position was assessed on a scale of 0-180 degree on both eyes.
-
Phase I: Absolute Lens Rotation
Time frame: 3 min after lens insertion during Phase I
Lens orientation position as assessed on a scale of 0-180 on both eyes.
Secondary outcomes
-
Phase I: Time to Lens Settling
Time frame: 5 minutes after lens insertion during Phase I
With random insertion and natural blinking, the slit lamp video was used to measure the time of lens settling.
-
Phase I: Number of Blinks Until Settled
Time frame: Baseline to 5 minutes during Phase I
Number of blinks for the right eye was counted until lens settling using headcam video.
Other outcomes
-
Phase II: Absolute Rotation
Time frame: 1-minute during Phase II
Absolute rotation of the lens (degrees) at 1-minute post-fit on both eyes. Filcon II 3 lens was only used for comparison in phase II of the study per study protocol.
Sponsors and collaborators
Lead sponsor
Johnson & Johnson Vision Care, Inc.
Industry
Registry information
Important dates
- Study start
- 2012
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Mar 13, 2012
- 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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