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Clinical Trials/ISRCTN16230269
ISRCTN16230269Completed未知

Crossover evaluation of two different eye drops in symptomatic soft contact lens wearers

CooperVision, Inc.0 sites20 target enrollmentStarted: June 7, 2019Last updated:
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Conditions

Trial Snapshot

Phase
未知
Status
Completed
Enrollment
20
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Subjects will be defined as symptomatic contact lens wearers if they present with at least one of the following two criteria at baseline:
  • •1. Difference in reported wearing time and comfortable wearing time >2 hours
  • •2. Score =14 by CLDEQ-8
  • •All subjects must satisfy the following conditions prior to enrolling in the study:
  • •1. Be =18 years of age
  • •2. Able to read, comprehend and sign an informed consent
  • •3. Willing to comply with the wear and study assessment schedule
  • •4. Adapted and current symptomatic soft CL wearers (i.e. >1 month of wear)
  • •5. Spherical spectacle prescription between +6.00 and -10.00D (inclusive)
  • •6. Correctable to 6/12 (20/40) or better in each eye
  • •7. Require visual correction in both eyes (monovision and multifocal allowed but no monofit)
  • •8. Have normal eyes with no evidence of any ocular abnormality or disease. For the purposes of this study a normal eye is defined as one having:
  • •8.1. Clear central corneas
  • •8.2. No anterior segment disorder
  • •8.3. No amblyopia
  • •8.4. No strabismus
  • •8.5. No evidence of lid abnormality or infection
  • •8.6. No conjunctival abnormality or infection that would contraindicate contact lens wear
  • •8.7. No clinically significant slit lamp findings (i.e. corneal oedema, staining, central scarring, infiltrates, active neovascularisation)
  • •8.8. No other active ocular disease or recent surgery

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 oedema, corneal vascularisation, tarsal abnormalities, bulbar hyperaemia, limbal hyperaemia, 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. 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)
  • •11. Pregnant or lactating or planning a pregnancy at the time of enrolment
  • •12. Participation in any concurrent clinical trial or any clinical trial in the last 14 days

Investigators

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