N/A
N=58
A Dispensing Clinical Trial of Test Contact Lens Against Marketed Contact Lens
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT03499067 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Lens Surface Wettability — 3.26; 3.26 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Test lens (Device); Control lens (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Surface Wettability |
3.11; 3.01 | — |
| PRIMARY Lens Surface Wettability |
3.11; 3.01 | — |
| PRIMARY Lens Surface Wettability |
3.11; 3.01 | — |
| PRIMARY Lens Surface Deposits |
0.35; 0.38 | — |
| PRIMARY Lens Surface Deposits |
0.35; 0.38 | — |
| PRIMARY Lens Surface Deposits |
0.35; 0.38 | — |
| PRIMARY Overall Lens Fit Acceptance |
3.31; 3.13 | — |
| PRIMARY Overall Lens Fit Acceptance |
3.31; 3.13 | — |
| PRIMARY Overall Lens Fit Acceptance |
3.31; 3.13 | — |
| PRIMARY Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration |
59; 33; 40; 59; 1; 8 | — |
| PRIMARY Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration |
59; 33; 40; 59; 1; 8 | — |
| PRIMARY Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration |
59; 33; 40; 59; 1; 8 | — |
| SECONDARY Bulbar Conjunctiva Hyperaemia |
1.15; 1.27 | — |
| SECONDARY Bulbar Conjunctiva Hyperaemia |
1.15; 1.27 | — |
| SECONDARY Bulbar Conjunctiva Hyperaemia |
1.15; 1.27 | — |
| SECONDARY Limbal Conjunctiva Hyperaemia |
0.65; 0.76 | — |
| SECONDARY Limbal Conjunctiva Hyperaemia |
0.65; 0.76 | — |
| SECONDARY Limbal Conjunctiva Hyperaemia |
0.65; 0.76 | — |
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.
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.
- Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit
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)
- Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
Data sourced from ClinicalTrials.gov (NCT03499067). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.