Clinical Trial of Several Contact Lense… | Clinical Trial

Key information

Myopia Eye Diseases Refractive Errors

18 year–39 year

All sexes

Interventional

Not applicable

Chennai, Tamil Nadu, 600 006, India

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Be of legal age, and be between 18 and 39 years of age.
Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
Require a visual correction in both eyes (Monovision not allowed)
Require a soft contact lens spherical correction between -0.50 and -9.00D.
Have an astigmatic correction less than 1.50D in both eyes.
Be able to wear the lens powers available for this study.
Be able to regularly wear the lenses on a 7 day/6 night extended wear basis (e.g. does not regularly swim more than once a week)
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 clinically significant slit lamp findings
No other active ocular disease.
No previous ocular surgery.

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.
No Clinically significant (Grade 3 or 4) slit lamp findings including corneal edema, corneal vascularization, 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).
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 enrolment 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 only.
Participation in any concurrent clinical trial.
Currently wearing B&L PureVision, Ciba O2 Optix, Ciba Night & Day, CooperVision Biofinity, Vistakon ACUVUE® OASYS, or Vistakon ACUVUE®2 on an EW basis
Has had previous adverse event(s) contraindicating EW e.g. MK or greater than 2 corneal scars which appear to be contact lens related (e.g. not trauma related).
Has had an eye injury or surgery within the last eight weeks.