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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02727816

Enrollment

Registered

2016-04-05

Start date

2016-04-30

Completion date

2016-08-31

Last updated

2018-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Brief summary

The aim of this non-dispensing study is to evaluate the clinical performance of different hydrogel contact lens designs.

Detailed description

This is a 35-subject, double masked, randomized, contra lateral, non-dispensing fitting trial comparing different hydrogel lens materials. For each study, this study will involve 2 visits: lens dispensing (baseline) and 1 hour post lens settling. Each subject will be randomized to wear the test and control lenses, in the right or left eye, in a series of four short fitting comparisons as follows: Pair 1 (P1): filcon IV I (Base Curve (BC) 8.6) and ocufilcon D Pair 2 (P2): filcon IV I (Base Curve (BC) 8.7) and ocufilcon D Pair 3 (P3): methafilcon A (Base Curve (BC) 8.6) and ocufilcon D Pair 4 (P4): methafilcon A (Base Curve (BC)8.7) and somofilcon A

Interventions

DEVICEfilcon IV I (BC 8.6)

control lens

DEVICEfilcon IV I (BC 8.7)

control lens

DEVICEocufilcon D

test lens

DEVICEmethafilcon A (BC 8.6)

control lens

DEVICEmethafilcon A (BC 8.7)

control lens

DEVICEsomofilcon A

test lens

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Centration - Pair One	Baseline and 1 hour	Centration for filcon IV I (Base Curve (BC) 8.6) / ocufilcon D (pair one) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Centration - Pair Two	Baseline and 1 hour	Centration for filcon IV I (Base Curve (BC) 8.7) / ocufilcon D (pair two) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Centration - Pair Three	Baseline and 1 hour	Centration for methafilcon A (Base Curve (BC) 8.6) / ocufilcon D (pair three) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Centration - Pair Four	Baseline and 1 hour	Centration for methafilcon A (Base Curve (BC) 8.7) / somofilcon A (pair four) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Post-blink Movement - Pair One	Baseline	Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair Two	Baseline	Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair Three	Baseline	Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair Four	Baseline	Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Lens Tightness - Pair One	Baseline and 1 hour	Lens tightness on push on test for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Lens Tightness - Pair Two	Baseline and 1 hour	Lens tightness on push on test for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Lens Tightness - Pair Three	Baseline and 1 hour	Lens tightness on push on test for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Lens Tightness - Pair Four	Baseline and 1 hour	Lens tightness on push on test for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Overall Fit Preference - Pair One	Baseline and 1 hour	Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. Three choices: filcon IV I (BC 8.6), ocufilcon D, or no preference.
Overall Fit Acceptance - Pair Two	Baseline and 1 hour	Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. Three choices: filcon IV I (BC 8.7), ocufilcon D, or no preference.
Overall Fit Acceptance - Pair Three	Baseline and 1 hour	Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. Three choices: methafilcon A (BC 8.6), ocufilcon D, or no preference.
Overall Fit Acceptance - Pair Four	Baseline and 1 hour	Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. Three choices: methafilcon A (BC 8.7), somofilcon A, or no preference.

Countries

Mexico

Participant flow

Participants by arm

Arm	Count
Overall Participants Participants were randomized to a test and control lens for each of the four lens pair in a contralateral design.	35
Total	35

Baseline characteristics

Characteristic	Overall Participants
Age, Continuous	22.5 years STANDARD_DEVIATION 2.8
Sex: Female, Male Female	23 Participants
Sex: Female, Male Male	12 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 35
other Total, other adverse events	0 / 35
serious Total, serious adverse events	0 / 35

Outcome results

Primary

Centration - Pair Four

Centration for methafilcon A (Base Curve (BC) 8.7) / somofilcon A (pair four) is assessed. (optimum, decentration acceptable, decentration unacceptable).