Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.

• Register: ClinicalTrials.gov
• Last refreshed on: 19 September 2016
• Main ID: NCT02727816
• Date of registration: 30/03/2016
• Prospective Registration: Yes
• Primary sponsor: Coopervision, Inc.
• Public title: Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.
• Scientific title: Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.
• Date of first enrolment: April 2016
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02727816
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
• Phase: N/A

Countries of recruitment

Mexico

Key inclusion & exclusion criteria

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

- Is between 18 and 40 years of age (inclusive).

- Has had a self-reported visual exam in the last two years.

- Is an adapted soft CL (Contact Lens) wearer.

- Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)

- Has a spectacle cylinder up to 0.75D (Diopters) in each eye.

- Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or
better in each eye.

- Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye
with the study contact lenses.

- Has clear corneas and no active ocular disease.

- Has read, understood and signed the information consent letter.

- Patient contact lens refraction should fit within the available parameters of the
study lenses.

- Is willing to comply with the wear schedule.

- Is willing to comply with the visit schedule.

Exclusion Criteria:

A person will be excluded from the study if he/she:

- Has never worn contact lenses before.

- Currently wears rigid gas permeable contact lenses.

- Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)

- Has a CL prescription outside the range of - 1.00 to - 6.00D

- Has a spectacle cylinder =1.00D of cylinder in either eye.

- Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in
either eye.

- Presence of clinically significant (grade 2-4) anterior segment abnormalities.

- Presence of ocular or systemic disease or need of medications which might interfere
with contact lens wear.

- Slit lamp findings that would contraindicate contact lens wear such as:

- Pathological dry eye or associated findings

- Pterygium, pinguecula, or corneal scars within the visual axis

- Neovascularization > 0.75 mm in from of the limbus

- Giant papillary conjunctivitis (GPC) worse than grade 1

- Anterior uveitis or iritis (past or present)

- Seborrheic eczema, Seborrheic conjunctivitis

- History of corneal ulcers or fungal infections

- Poor personal hygiene

- Has a known history of corneal hypoesthesia (reduced corneal sensitivity)

- Has aphakia, keratoconus or a highly irregular cornea.

- Has Presbyopia or has dependence on spectacles for near work over the contact lenses.

- Has undergone corneal refractive surgery.

- Is participating in any other type of eye related clinical or research study.



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Myopia

Intervention(s)

Device: ocufilcon D

Device: filcon IV I (BC 8.7)

Device: filcon IV I (BC 8.6)

Device: methafilcon A (BC 8.6)

Device: methafilcon A (BC 8.7)

Device: somofilcon A

Primary Outcome(s)

Centration - pair three [Time Frame: Up to 1 hour]

Lens tightness - pair three [Time Frame: Up to 1 hour]

Lens tightness - pair one [Time Frame: Up to 1 hour]

Post-blink movement - pair four [Time Frame: Up to 1 hour]

Centration - pair two [Time Frame: Up to 1 hour]

Lens tightness - pair two [Time Frame: Up to 1 hour]

Post-blink movement - pair three [Time Frame: Up to 1 hour]

Lens tightness - pair four [Time Frame: Up to 1 hour]

Overall fit acceptance - pair three [Time Frame: Up to 1 hour]

Centration - pair four [Time Frame: Up to 1 hour]

Centration - pair one [Time Frame: Up to 1 hour]

Overall fit acceptance - pair four [Time Frame: Up to 1 hour]

Post-blink movement - pair one [Time Frame: Up to 1 hour]

Overall fit acceptance - pair one [Time Frame: Up to 1 hour]

Post-blink movement - pair two [Time Frame: Up to 1 hour]

Overall fit acceptance - pair two [Time Frame: Up to 1 hour]

Secondary ID(s)

EX-MKTG-65

Source(s) of Monetary Support

Please refer to primary and secondary sponsors