Clinical trial NCT03779503: Comparison of Two Daily Disposable Soft Contact Lenses
Official title: A Clinical Comparison of Two Daily Disposable Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism Bilateral
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2018-12-19
Enrollment: 55
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 study was to investigate the short-term clinical performance and subjective acceptance of the two study lenses.

Detailed description: This study was a randomised, double-masked, crossover, bilateral dispensing study, controlled by cross-comparison. Fifty-five subjects will wear each lens brand for approximately one week in random order. Lenses were worn on a daily wear, daily disposable basis.

Eligibility criteria: Inclusion Criteria:

1. They are between 18 and 40 years of age (inclusive).
2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They are an existing silicone hydrogel reusable spherical contact lens wearer in both eyes.
5. They have a contact lens spherical prescription between -0.25D and -6.00D (inclusive) based on ocular refraction.
6. They own a wearable pair of spectacles and wear them on the day of the initial visit.
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, or use any rewetting/lubricating drops whilst on this study.
4. They are aphakic.
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 contact lens or care system clinical research within two weeks prior to starting this study.

Primary outcomes:
measure: Lens Fit - Horizontal Centration
timeFrame: Baseline
measure: Lens Fit - Horizontal Centration
timeFrame: One Week
measure: Lens Fit - Vertical Centration
timeFrame: Baseline
measure: Lens Fit - Vertical Centration
timeFrame: One Week
measure: Lens Fit - Corneal Coverage
timeFrame: Baseline
measure: Lens Fit - Corneal Coverage
timeFrame: One Week
measure: Lens Fit - Lens Movement
timeFrame: Baseline
measure: Lens Fit - Lens Movement
timeFrame: One Week
Secondary outcomes:
measure: Subjective Score for Vision
timeFrame: Baseline
measure: Subjective Score for Vision
timeFrame: One week
Other outcomes:
Locations:
city: Pleasanton
country: United States
facility: CooperVision Inc.
state: California
Study officials:
affiliation: Eurolens Research
name: Philip Morgan, PhD MCOptom FAAO FBCLA
role: PRINCIPAL_INVESTIGATOR
References: