NCT04613882
Completed
Not Applicable
Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses Over a Range of Refractive Astigmatism
ConditionsAstigmatism
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Astigmatism
- Sponsor
- Coopervision, Inc.
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Visual Acuity
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The aim of this work is to undertake a range of vision-related measures with soft toric contact lenses soft spherical contact lenses and spectacle lens correction across a range of levels of astigmatism.
Detailed Description
This will be a randomised, crossover, partially subject-masked (for contact lenses only), non-dispensing study, controlled by cross-comparison.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects will only be eligible for the study if:
- •They are of legal age between 18 and 40 years.
- •They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- •They are willing and able to follow the protocol.
- •They are current wearers of any soft contact lens (i.e. have worn lenses in the last six months).
- •They have refractive ocular astigmatism between 0.00DC and -1.50DC in one or both eyes.
- •They have a spherical component to their ocular refractive error between 0.00 and - 6.00 DS.
- •They could attain at least 0.10 logMAR distance high contrast visual acuity in one eye with the study lenses within the available power range.
- •They can be fitted satisfactorily with both lens types.
- •They own an acceptable pair of spectacles.
Exclusion Criteria
- •Subjects will not be eligible to take part in the study if:
- •They have an ocular disorder which would normally contra-indicate contact lens wear.
- •They have a systemic disorder which would normally contra-indicate contact lens wear.
- •They are using any topical medication such as eye drops or ointment.
- •They have had corneal refractive surgery.
- •They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- •They are pregnant or breastfeeding.
- •They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
- •They have an amblyopic eye, in which case only dominant eye will be assessed for that subject.
- •They have an infectious disease (e.g. hepatitis), any immunosuppressive disease (e.g. HIV) or diabetes.
Outcomes
Primary Outcomes
Visual Acuity
Time Frame: After 30 minutes of dispense (High Contrast VA)
Visual acuity was assessed using logMAR for each intervention.
Secondary Outcomes
- Slit Lamp Biomicroscopy Findings - Corneal Staining(At Exit (After 30 minutes in each of three interventions))
- Slit Lamp Biomicroscopy Findings - Corneal Oedema(At Exit (After 30 minutes in each of three interventions))
- Slit Lamp Biomicroscopy Findings - Conjunctival Staining(At Exit (After 30 minutes in each of three interventions))
- Slit Lamp Biomicroscopy Findings - Conjunctival Redness(At Exit (After 30 minutes in each of three interventions))
- Slit Lamp Biomicroscopy Findings - Limbal Redness(At Exit (After 30 minutes in each of three interventions))
- Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis(At Exit (After 30 minutes in each of three interventions))
Study Sites (1)
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