Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses
- Conditions
- Astigmatism
- Registration Number
- NCT04613882
- Lead Sponsor
- Coopervision, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
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.
- They agree not to participate in other clinical research for the duration of this study.
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.
- They have a history of severe allergic reaction or anaphylaxis.
- They have taken part in any other contact lens clinical trial or research, within two weeks prior to starting this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Visual Acuity After 30 minutes of dispense (High Contrast VA) Visual acuity was assessed using logMAR for each intervention.
- Secondary Outcome Measures
Name Time Method Slit Lamp Biomicroscopy Findings - Corneal Staining At Exit (After 30 minutes in each of three interventions) Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.Slit Lamp Biomicroscopy Findings - Corneal Oedema At Exit (After 30 minutes in each of three interventions) Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention.
Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.Slit Lamp Biomicroscopy Findings - Conjunctival Staining At Exit (After 30 minutes in each of three interventions) Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.Slit Lamp Biomicroscopy Findings - Conjunctival Redness At Exit (After 30 minutes in each of three interventions) Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.Slit Lamp Biomicroscopy Findings - Limbal Redness At Exit (After 30 minutes in each of three interventions) Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis At Exit (After 30 minutes in each of three interventions) Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
The assessments were done following the removal of the third intervention.
Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (1)
Eurolens Research
🇬🇧Manchester, United Kingdom
Eurolens Research🇬🇧Manchester, United Kingdom