Myopia
Conditions
Brief summary
The aim of this non-dispensing fitting study is to evaluate the short term lens fit, vision performance of three monthly replacement sphere lenses.
Detailed description
This is a 40-subject, double masked, randomized, bilateral, non-dispensing fitting trial comparing hydrogel and silicone hydrogel lens materials. It is anticipated that this study will involve 2 visits for each lens pair, as follows: Visits: V1 (lens dispensing), V2 (1 hour post lens settling). Each subject will be randomized to wear each pair bilaterally in a series of three short fitting comparisons.
Interventions
DEVICEOmafilcon A
contact lens
DEVICESomofilcon A
contact lens
DEVICEOmafilcon A - Proclear (PC)
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
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 who is not wearing any of the study lenses. * Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive) * Has a spectacle cylinder up to 0.75D (Diopter) 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 (GCP) 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 |
|---|---|---|
| Visual Acuity | Baseline (lens insertion), 1 hour | High contrast distance visual acuity assessed for each lens pair using LogMAR chart at time of lens insertion, then assessing again 1 hour later with spectacles after lenses are removed. |
| Comfort | Insertion, 1hr | Subjective comfort (Scale 0-100: 0=very uncomfortable, 100= very comfortable) |
| Lens Centration | Insertion | Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable) |
| Post-blink Lens Movement | Insertion | Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive) |
| Lens Fit Acceptance | Insertion | Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect) |
| Limbal Redness | 1 Hour | Redness of limbal area (Scale: 0-4, 0 = none, 4=severe) |
| Lens Fit Preference | 1 Hour | Investigator lens fit preference (Scale: omafilcon A, somofilcon A, omafilcon A - Proclear (PC)) |
| Bulbar Redness | 1 Hour | Redness of bulbar conjunctiva (Scale: 0-4, 0 = none, 4=severe) |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Participants are randomized to wear omafilcon A lens pair, Somofilcon A lens pair, Omafilcon A - Proclear PC bilaterally for 1 hour during the study on separate days | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 40 Participants | — |
| Age, Continuous | 27.3 years STANDARD_DEVIATION 6.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Mexico | 40 participants | — |
| Sex: Female, Male Female | 30 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 40 |
Outcome results
Primary
Bulbar Redness
Redness of bulbar conjunctiva (Scale: 0-4, 0 = none, 4=severe)
Time frame: 1 Hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omafilcon A | Bulbar Redness | 0.51 units on a scale | Standard Deviation 0.36 |
| Somofilcon A | Bulbar Redness | 0.55 units on a scale | Standard Deviation 0.38 |
| Omafilcon A - Proclear (PC) | Bulbar Redness | 0.50 units on a scale | Standard Deviation 0.37 |
Primary
Comfort
Subjective comfort (Scale 0-100: 0=very uncomfortable, 100= very comfortable)
Time frame: Insertion, 1hr
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Comfort | Insertion | 94.5 units on a scale | Standard Deviation 8.5 |
| Omafilcon A | Comfort | 1 Hour | 95.8 units on a scale | Standard Deviation 8.2 |
| Somofilcon A | Comfort | Insertion | 98.0 units on a scale | Standard Deviation 5 |
| Somofilcon A | Comfort | 1 Hour | 96.8 units on a scale | Standard Deviation 5.5 |
| Omafilcon A - Proclear (PC) | Comfort | Insertion | 94.7 units on a scale | Standard Deviation 7.4 |
| Omafilcon A - Proclear (PC) | Comfort | 1 Hour | 93.7 units on a scale | Standard Deviation 10.7 |
Primary
Lens Centration
Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)
Time frame: Insertion
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Omafilcon A | Lens Centration | Decentration Acceptable | 0 Participants |
| Omafilcon A | Lens Centration | Optimum | 40 Participants |
| Omafilcon A | Lens Centration | Decentration Unacceptable | 0 Participants |
| Somofilcon A | Lens Centration | Decentration Acceptable | 0 Participants |
| Somofilcon A | Lens Centration | Optimum | 40 Participants |
| Somofilcon A | Lens Centration | Decentration Unacceptable | 0 Participants |
| Omafilcon A - Proclear (PC) | Lens Centration | Optimum | 40 Participants |
| Omafilcon A - Proclear (PC) | Lens Centration | Decentration Unacceptable | 0 Participants |
| Omafilcon A - Proclear (PC) | Lens Centration | Decentration Acceptable | 0 Participants |
Primary
Lens Centration
Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)
Time frame: 1 Hour
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Omafilcon A | Lens Centration | Decentration Acceptable | 0 Participants |
| Omafilcon A | Lens Centration | Optimum | 40 Participants |
| Omafilcon A | Lens Centration | Decentration Unacceptable | 0 Participants |
| Somofilcon A | Lens Centration | Decentration Acceptable | 0 Participants |
| Somofilcon A | Lens Centration | Optimum | 40 Participants |
| Somofilcon A | Lens Centration | Decentration Unacceptable | 0 Participants |
| Omafilcon A - Proclear (PC) | Lens Centration | Optimum | 40 Participants |
| Omafilcon A - Proclear (PC) | Lens Centration | Decentration Unacceptable | 0 Participants |
| Omafilcon A - Proclear (PC) | Lens Centration | Decentration Acceptable | 0 Participants |
Primary
Lens Fit Acceptance
Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)
Time frame: 1 Hour
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Omafilcon A | Lens Fit Acceptance | OK to dispense | 5 Participants |
| Omafilcon A | Lens Fit Acceptance | Min acceptable | 5 Participants |
| Omafilcon A | Lens Fit Acceptance | Shouldn't be worn | 0 Participants |
| Omafilcon A | Lens Fit Acceptance | Borderline | 0 Participants |
| Omafilcon A | Lens Fit Acceptance | Perfect | 30 Participants |
| Somofilcon A | Lens Fit Acceptance | Min acceptable | 1 Participants |
| Somofilcon A | Lens Fit Acceptance | Shouldn't be worn | 1 Participants |
| Somofilcon A | Lens Fit Acceptance | Borderline | 0 Participants |
| Somofilcon A | Lens Fit Acceptance | OK to dispense | 3 Participants |
| Somofilcon A | Lens Fit Acceptance | Perfect | 35 Participants |
| Omafilcon A - Proclear (PC) | Lens Fit Acceptance | Perfect | 33 Participants |
| Omafilcon A - Proclear (PC) | Lens Fit Acceptance | OK to dispense | 3 Participants |
| Omafilcon A - Proclear (PC) | Lens Fit Acceptance | Shouldn't be worn | 0 Participants |
| Omafilcon A - Proclear (PC) | Lens Fit Acceptance | Min acceptable | 0 Participants |
| Omafilcon A - Proclear (PC) | Lens Fit Acceptance | Borderline | 4 Participants |
Primary
Lens Fit Acceptance
Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)
Time frame: Insertion
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Omafilcon A | Lens Fit Acceptance | OK to dispense | 10 Participants |
| Omafilcon A | Lens Fit Acceptance | Min acceptable | 2 Participants |
| Omafilcon A | Lens Fit Acceptance | Shouldn't be worn | 0 Participants |
| Omafilcon A | Lens Fit Acceptance | Borderline | 2 Participants |
| Omafilcon A | Lens Fit Acceptance | Perfect | 26 Participants |
| Somofilcon A | Lens Fit Acceptance | Min acceptable | 1 Participants |
| Somofilcon A | Lens Fit Acceptance | Shouldn't be worn | 0 Participants |
| Somofilcon A | Lens Fit Acceptance | Borderline | 2 Participants |
| Somofilcon A | Lens Fit Acceptance | OK to dispense | 8 Participants |
| Somofilcon A | Lens Fit Acceptance | Perfect | 29 Participants |
| Omafilcon A - Proclear (PC) | Lens Fit Acceptance | Perfect | 22 Participants |
| Omafilcon A - Proclear (PC) | Lens Fit Acceptance | OK to dispense | 10 Participants |
| Omafilcon A - Proclear (PC) | Lens Fit Acceptance | Shouldn't be worn | 1 Participants |
| Omafilcon A - Proclear (PC) | Lens Fit Acceptance | Min acceptable | 3 Participants |
| Omafilcon A - Proclear (PC) | Lens Fit Acceptance | Borderline | 4 Participants |
Primary
Lens Fit Preference
Investigator lens fit preference (Scale: omafilcon A, somofilcon A, omafilcon A - Proclear (PC))
Time frame: 1 Hour
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Omafilcon A | Lens Fit Preference | omafilcon A | 5 Participants |
| Omafilcon A | Lens Fit Preference | somofilcon A | 2 Participants |
| Omafilcon A | Lens Fit Preference | omafilcon A - Proclear (PC) | 6 Participants |
| Omafilcon A | Lens Fit Preference | No Preference | 27 Participants |
Primary
Limbal Redness
Redness of limbal area (Scale: 0-4, 0 = none, 4=severe)
Time frame: 1 Hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omafilcon A | Limbal Redness | 0.41 units on a scale | Standard Deviation 0.3 |
| Somofilcon A | Limbal Redness | 0.39 units on a scale | Standard Deviation 0.3 |
| Omafilcon A - Proclear (PC) | Limbal Redness | 0.39 units on a scale | Standard Deviation 0.3 |
Primary
Post-blink Lens Movement
Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)
Time frame: 1 Hour
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Omafilcon A | Post-blink Lens Movement | Excessive | 0 Participants |
| Omafilcon A | Post-blink Lens Movement | Optimum | 31 Participants |
| Omafilcon A | Post-blink Lens Movement | Minimum | 7 Participants |
| Omafilcon A | Post-blink Lens Movement | Moderate | 2 Participants |
| Omafilcon A | Post-blink Lens Movement | Insufficient | 0 Participants |
| Somofilcon A | Post-blink Lens Movement | Optimum | 37 Participants |
| Somofilcon A | Post-blink Lens Movement | Minimum | 1 Participants |
| Somofilcon A | Post-blink Lens Movement | Insufficient | 1 Participants |
| Somofilcon A | Post-blink Lens Movement | Moderate | 1 Participants |
| Somofilcon A | Post-blink Lens Movement | Excessive | 0 Participants |
| Omafilcon A - Proclear (PC) | Post-blink Lens Movement | Excessive | 0 Participants |
| Omafilcon A - Proclear (PC) | Post-blink Lens Movement | Moderate | 2 Participants |
| Omafilcon A - Proclear (PC) | Post-blink Lens Movement | Minimum | 4 Participants |
| Omafilcon A - Proclear (PC) | Post-blink Lens Movement | Optimum | 34 Participants |
| Omafilcon A - Proclear (PC) | Post-blink Lens Movement | Insufficient | 0 Participants |
Primary
Post-blink Lens Movement
Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)
Time frame: Insertion
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Omafilcon A | Post-blink Lens Movement | Moderate | 3 Participants |
| Omafilcon A | Post-blink Lens Movement | Optimum | 27 Participants |
| Omafilcon A | Post-blink Lens Movement | Insufficient | 1 Participants |
| Omafilcon A | Post-blink Lens Movement | Excessive | 0 Participants |
| Omafilcon A | Post-blink Lens Movement | Minimum | 9 Participants |
| Somofilcon A | Post-blink Lens Movement | Minimum | 1 Participants |
| Somofilcon A | Post-blink Lens Movement | Insufficient | 0 Participants |
| Somofilcon A | Post-blink Lens Movement | Optimum | 31 Participants |
| Somofilcon A | Post-blink Lens Movement | Moderate | 8 Participants |
| Somofilcon A | Post-blink Lens Movement | Excessive | 0 Participants |
| Omafilcon A - Proclear (PC) | Post-blink Lens Movement | Excessive | 0 Participants |
| Omafilcon A - Proclear (PC) | Post-blink Lens Movement | Moderate | 13 Participants |
| Omafilcon A - Proclear (PC) | Post-blink Lens Movement | Insufficient | 1 Participants |
| Omafilcon A - Proclear (PC) | Post-blink Lens Movement | Optimum | 19 Participants |
| Omafilcon A - Proclear (PC) | Post-blink Lens Movement | Minimum | 7 Participants |
Primary
Visual Acuity
High contrast distance visual acuity assessed for each lens pair using LogMAR chart at time of lens insertion, then assessing again 1 hour later with spectacles after lenses are removed.
Time frame: Baseline (lens insertion), 1 hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Visual Acuity | Lens Insertion (CL) | -0.04 logMAR | Standard Deviation 0.05 |
| Omafilcon A | Visual Acuity | 1 Hour (Specs) | -0.01 logMAR | Standard Deviation 0.03 |
| Somofilcon A | Visual Acuity | Lens Insertion (CL) | -0.05 logMAR | Standard Deviation 0.05 |
| Somofilcon A | Visual Acuity | 1 Hour (Specs) | -0.01 logMAR | Standard Deviation 0.03 |
| Omafilcon A - Proclear (PC) | Visual Acuity | Lens Insertion (CL) | -0.03 logMAR | Standard Deviation 0.04 |
| Omafilcon A - Proclear (PC) | Visual Acuity | 1 Hour (Specs) | -0.01 logMAR | Standard Deviation 0.02 |