Clinical trial NCT01552876: Comparative Clinical Evaluation of Soft Toric Lens Designs
Official title: Comparative Clinical Evaluation of Soft Toric Lens Designs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-13
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is evaluating the initial fit of toric contact lenses.


Eligibility criteria: 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.

Primary outcomes:
measure: Phase I: Absolute Lens Rotation
timeFrame: At 1-min after lens insertion during Phase I
measure: Phase I: Absolute Lens Rotation
timeFrame: 3 min after lens insertion during Phase I
Secondary outcomes:
measure: Phase I: Time to Lens Settling
timeFrame: 5 minutes after lens insertion during Phase I
measure: Phase I: Number of Blinks Until Settled
timeFrame: Baseline to 5 minutes during Phase I
Other outcomes:
measure: Phase II: Absolute Rotation
timeFrame: 1-minute during Phase II
Locations:
city: Farnham
country: United Kingdom
Study officials:
References: