Clinical trial NCT04613882: Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses
Official title: Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses Over a Range of Refractive Astigmatism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2020-11-03
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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Subjects will only be eligible for the study if:

1. They are of legal age between 18 and 40 years.
2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They are current wearers of any soft contact lens (i.e. have worn lenses in the last six months).
5. They have refractive ocular astigmatism between 0.00DC and -1.50DC in one or both eyes.
6. They have a spherical component to their ocular refractive error between 0.00 and - 6.00 DS.
7. 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.
8. They can be fitted satisfactorily with both lens types.
9. They own an acceptable pair of spectacles.
10. They agree not to participate in other clinical research for the duration of this study.

Exclusion Criteria:

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Subjects will not be eligible to take part in the study if:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They have had corneal refractive surgery.
5. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
6. They are pregnant or breastfeeding.
7. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
8. They have an amblyopic eye, in which case only dominant eye will be assessed for that subject.
9. They have an infectious disease (e.g. hepatitis), any immunosuppressive disease (e.g. HIV) or diabetes.
10. They have a history of severe allergic reaction or anaphylaxis.
11. They have taken part in any other contact lens clinical trial or research, within two weeks prior to starting this study.

Primary outcomes:
measure: Visual Acuity
timeFrame: Baseline with low contrast VA
measure: Visual Acuity
timeFrame: After 30 minutes of dispense (Low Contrast VA)
measure: Visual Acuity
timeFrame: Baseline with High contrast VA
measure: Visual Acuity
timeFrame: After 30 minutes of dispense (High Contrast VA)
Secondary outcomes:
measure: Slit Lamp Biomicroscopy Findings - Conjunctival Redness
timeFrame: Entrance (Prior to wear of study lens)
measure: Slit Lamp Biomicroscopy Findings - Conjunctival Redness
timeFrame: At Exit (After 30 minutes in each of three interventions)
measure: Slit Lamp Biomicroscopy Findings - Limbal Redness
timeFrame: Entrance (Prior to wear of study lens)
measure: Slit Lamp Biomicroscopy Findings - Limbal Redness
timeFrame: At Exit (After 30 minutes in each of three interventions)
measure: Slit Lamp Biomicroscopy Findings - Corneal Staining
timeFrame: Entrance (Prior to wear of study lens)
measure: Slit Lamp Biomicroscopy Findings - Corneal Staining
timeFrame: At Exit (After 30 minutes in each of three interventions)
measure: Slit Lamp Biomicroscopy Findings - Conjunctival Staining
timeFrame: Entrance (Prior to wear of study lens)
measure: Slit Lamp Biomicroscopy Findings - Conjunctival Staining
timeFrame: At Exit (After 30 minutes in each of three interventions)
measure: Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis
timeFrame: Entrance (Prior to wear of study lens)
measure: Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis
timeFrame: At Exit (After 30 minutes in each of three interventions)
measure: Slit Lamp Biomicroscopy Findings - Corneal Oedema
timeFrame: Entrance (Prior to wear of study lens)
measure: Slit Lamp Biomicroscopy Findings - Corneal Oedema
timeFrame: At Exit (After 30 minutes in each of three interventions)
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research
Study officials:
affiliation: Eurolens Research
name: Michael Read
role: PRINCIPAL_INVESTIGATOR
References: