Clinical trial NCT04195581: A Clinical Evaluation of Two Contact Lenses Used With Three Care Systems
Official title: A Clinical Evaluation of Two Contact Lenses Used With Three Care Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2019-12-12
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects will use each lens and solution combination for a month in random sequence for a total of six months.
Primary purpose: TREATMENT

Brief summary: The objective of the study was to compare the clinical performance of the two contact lenses when used in combination with three care systems.

Detailed description: This was a randomized, open-label, crossover study, controlled by cross-comparison. Subjects were randomized to wear each lens and solution combination for a month in random sequence; that is for a total of six months.

Eligibility criteria: Inclusion Criteria:

1. They are aged 18-50 and have capacity to volunteer.
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 an existing wearer of reusable, single vision, spherical soft contact lenses.
5. They have a contact lens spherical prescription between -1.00 to - 6.50D (inclusive)
6. They have a spectacle cylindrical correction of -1.00D or less in each eye.
7. At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
8. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
9. They agree not to participate in other clinical research for the duration of the study.

Exclusion Criteria:

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 cataract surgery.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
7. They are pregnant or breastfeeding.
8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
9. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
10. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Primary outcomes:
measure: Overall Comfort
timeFrame: One Month
measure: Comfort on Insertion
timeFrame: One Month
measure: Comfort Before Removal
timeFrame: One Month
Secondary outcomes:
measure: Vision
timeFrame: One Month
measure: Variable Vision
timeFrame: One Month
measure: Vision at Night
timeFrame: One Month
measure: Dryness
timeFrame: One Month
measure: Ocular Redness
timeFrame: One Month
measure: Burning/Stinging
timeFrame: One Month
measure: Ease of Lens Insertion
timeFrame: One Month
measure: Ease of Lens Removal
timeFrame: One Month
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The University of Manchester
Study officials:
affiliation: Eurolens Research
name: Philip Morgan, MCOptom FAAO FBCLA
role: PRINCIPAL_INVESTIGATOR
References: