Clinical trial NCT03235115: Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses
Official title: Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2017-08-01
Enrollment: 40
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: This study aims to compare the short-term clinical performance of the three contact lenses (Methafilcon A IV, Ocufilcon B 1-day and Omafilcon A 1-day daily disposable).

Detailed description: This will be a randomized, double-masked, crossover, bilateral non-dispensing study, controlled by cross-comparison. Forty subjects will wear each lens brand for approximately one hour, on three separate study days in random order. Lenses will only be worn during study visits.

Eligibility criteria: Inclusion Criteria:

* They are of aged 18-40 and have 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 (based on the ocular refraction).
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Visual Acuity Using logMAR
timeFrame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
measure: Lens Fit - Horizontal Centration
timeFrame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
measure: Lens Fit - Vertical Centration
timeFrame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
measure: Lens Fit - Corneal Coverage of Lens
timeFrame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
measure: Lens Fit - Movement of Lens
timeFrame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research - The University of Manchester
Study officials:
References: