CompletedInterventionalNot ApplicableUpdated Jun 19, 2018
Comparative Clinical Evaluation of Soft Toric Lens Designs
Comparative Clinical Evaluation of Soft Toric Lens Designs
ClinicalTrials.gov ID
NCT01552876
Lead Sponsor
Johnson & Johnson Vision Care, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
42Actual
Last Update Posted
Jun 19, 2018Actual
Start Date
Feb 2012
Primary Completion Date
Apr 2012Actual
Completion Date
Apr 2012Actual
Official Title
Comparative Clinical Evaluation of Soft Toric Lens Designs
Brief Summary
This study is evaluating the initial fit of toric contact lenses.
Astigmatism
Myopia
etafilcon A
nelfilcon A
Filcon II 3
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
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.