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N/A N=58 Randomized Double-blind Treatment

A Dispensing Clinical Trial of Test Contact Lens Against Marketed Contact Lens

Myopia

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

OutcomeResultp-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).
View full record on ClinicalTrials.gov →

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.

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