A Dispensing Clinical Trial of Invigor I Lens Against Clariti Lens
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Coopervision, Inc.
- Enrollment
- 58
- Locations
- 2
- Primary Endpoint
- Overall Lens Fit Acceptance
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed lens (control), when worn on a daily basis for 1 month.
Detailed Description
Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed silicone- hydrogel contact lens (control), when worn on a daily basis for 1 month.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Has had a self-reported oculo-visual examination in the last two years.
- •Is at least 18 years of age and has full legal capacity to volunteer.
- •Has read and understood the information consent letter.
- •Is willing and able to follow instructions and maintain the appointment schedule.
- •Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- •Currently wears soft contact lenses.
- •Requires spectacle lens powers between -0.75 to -6.50 diopters sphere (0.25D steps).
- •Has no more than 0.75 diopters of refractive astigmatism.
- •Has clear corneas and no active ocular disease.
- •Has not worn lenses for at least 12 hours before the examination.
Exclusion Criteria
- •Has never worn contact lenses before.
- •Has any systemic disease affecting ocular health.
- •Is using any systemic or topical medications that will affect ocular health.
- •Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
- •Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- •Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- •Is aphakic.
- •Has undergone corneal refractive surgery.
- •Is participating in any other type of eye related clinical or research study.
- •Known allergy to a product used in this study (ex. Shellfish allergy)
Outcomes
Primary Outcomes
Overall Lens Fit Acceptance
Time Frame: 4-Weeks
Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
Time Frame: 4-weeks
Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (\<0.5mm), Extremely decentered (\>0.5mm)
Lens Surface Wettability
Time Frame: 4-weeks
Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time \<\< blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)
Lens Surface Deposits
Time Frame: 4-weeks
Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits,1: 5 or less small deposits (\<0.1mm), 2: \>5 deposits of \<0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface)
Secondary Outcomes
- Limbal Conjunctiva Hyperaemia(4-weeks)
- Bulbar Conjunctiva Hyperaemia(4-weeks)