Clinical trial NCT02643004: The Clinical Comparison of Senofilcon A and Stenfilcon A Contact Lenses
Official title: The Clinical Comparison of Senofilcon A and Stenfilcon A Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2015-12-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the clinical performance of senofilcon A lens with the stenfilcon A lens each for one week of daily disposable wear.

Detailed description: The purpose of this bilateral cross-over study is to evaluate the clinical performance of senofilcon A lens with the stenfilcon A lens. In particular, the study will focus on ocular physiology, lens fit, lens surface, visual acuity, and subjective response.

Eligibility criteria: Inclusion criteria

Subjects will only be eligible for the study if:

* They are of legal age (18) and capacity to volunteer.
* 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 agree not to participate in other clinical research for the duration of this study.
* They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)
* They have a spectacle cylindrical correction of -0.75D or less in each eye.
* At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
* They currently use soft contact lenses or have done so in the previous six months.
* They are willing to comply with the wear schedule (at least six days per week and for at least eight hours per day).

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 cataract surgery.
* 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 lactating.
* They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
* 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.
* They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
* They currently wear either MyDay (daily) or the Acuvue Oasys (2 weekly) lens.

Primary outcomes:
measure: Ocular Physiology
timeFrame: Baseline and 1 week
measure: Overall Subjective Score of Lenses
timeFrame: Baseline and 1 week
measure: Comfort
timeFrame: Baseline and 1 week
measure: Dryness
timeFrame: 1 week
measure: Vision
timeFrame: Baseline and 1 week
Secondary outcomes:
measure: Horizontal Centration
timeFrame: Baseline
measure: Horizontal Centration
timeFrame: 1 Week
measure: Vertical Centration
timeFrame: Baseline
measure: Vertical Centration
timeFrame: 1 Week
measure: Lens Movement
timeFrame: Baseline
measure: Lens Movement
timeFrame: 1 Week
measure: Visual Acuity
timeFrame: Baseline and 1 week
measure: Lens Surface - Deposition
timeFrame: Baseline
measure: Lens Surface - Deposition
timeFrame: 1 week
measure: Lens Surface - Debris
timeFrame: Baseline
measure: Lens Surface - Debris
timeFrame: 1 week
measure: Lens Surface - Wettability
timeFrame: Baseline
measure: Lens Surface - Wettability
timeFrame: 1 week
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research - The University of Manchester
Study officials:
affiliation: Eurolens Research, University of Manchester
name: Carole Maldonado-Codinal, PhD
role: PRINCIPAL_INVESTIGATOR
References: