Skip to main content
Clinical Trials/ISRCTN11194798
ISRCTN11194798
Completed
未知

Crossover evaluation of Clinitas Soothe® eye drops in symptomatic soft contact lens wearers (part 1)

CooperVision Inc. (USA)0 sites15 target enrollmentMarch 1, 2019

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
CooperVision Inc. (USA)
Enrollment
15
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 1, 2019
End Date
August 7, 2017
Last Updated
7 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
CooperVision Inc. (USA)

Eligibility Criteria

Inclusion Criteria

  • 1\. \=18 years of age
  • 2\. Adapted and current symptomatic soft CL wearers (i.e. \>1 month of wear)
  • 3\. Spherical spectacle prescription between \+6\.00 and \-10\.00D (inclusive)
  • 4\. Correctable to 6/12 (20/40\) or better in each eye
  • 5\. Require visual correction in both eyes (monovision allowed but no monofit)
  • 6\. Have normal eyes with no evidence of any ocular abnormality or disease.

Exclusion Criteria

  • 1\. Previously shown sensitivity to any of the study solutions’ components.
  • 2\. Any systemic or ocular disease or allergies affecting ocular health.
  • 3\. Using systemic or topical medications that will, in the investigator’s opinion, affect ocular physiology or lens performance.
  • 4\. Clinically significant (\>Grade 3\) corneal stromal edema, corneal vascularisation, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
  • 5\. Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea.
  • 6\. Keratoconus or other corneal irregularity.
  • 7\. Aphakia or amblyopia.
  • 8\. Has diabetes.
  • 9\. Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
  • 10\. History of chronic eye disease (e.g. glaucoma or ARMD).

Outcomes

Primary Outcomes

Not specified

Similar Trials