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The aim of this non-dispensing fitting study is to evaluate the short term lens fit, vision performance of three monthly replacement sphere lenses.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omafilcon A | Active Comparator | Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study. |
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| Somofilcon A | Active Comparator | Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study. |
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| Omafilcon A - Proclear (PC) | Active Comparator | Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omafilcon A | Device | contact lens |
| |
| Somofilcon A |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (lens insertion), 1 hour |
| Comfort | Subjective comfort (Scale 0-100: 0=very uncomfortable, 100= very comfortable) | Insertion, 1hr |
| Lens Centration | Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable) | Insertion |
| Lens Centration | Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable) | 1 Hour |
| Post-blink Lens Movement | Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive) | Insertion |
| Post-blink Lens Movement | Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive) | 1 Hour |
| Lens Fit Acceptance | Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect) | Insertion |
| Lens Fit Acceptance |
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Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Ruben Velázquez Guerrero, MSc., FIACLE | National Autonomous University, School of Optometry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optometry Clinic, National Autonomous University | Mexico City | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omafilcon A, Omafilcon A - Proclear (PC), Somofilcon A | Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during this double masked nondispensing fitting study, then omafilcon A - Proclear (PC), then Somofilcon A lens pair bilaterally for 1 hour. |
| FG001 | Omafilcon A, Somofilcon A, Omafilcon A - Proclear (PC) | Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during this double masked nondispensing fitting study, then Somofilcon A, then omafilcon A - Proclear (PC) lens pair bilaterally for 1 hour. |
| FG002 | Somofilcon A, Omafilcon A - Proclear (PC), Omafilcon A | Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during this double masked nondispensing fitting study, then omafilcon A - Proclear (PC), then omafilcon A lens pair bilaterally for 1 hour. |
| FG003 | Somofilcon A, Omafilcon A, Omafilcon A- Proclear (PC) | Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during this double masked nondispensing fitting study, then omafilcon A, then omafilcon A - Proclear (PC) lens pair bilaterally for 1 hour. |
| FG004 | Omafilcon A - Proclear (PC), Omafilcon A, Somofilcon A | Participants are randomized to wear omafilcon A - Proclear (PC) lens pair bilaterally for 1 hour during this double masked nondispensing fitting study, then omafilcon A, then somofilcon A lens pair bilaterally for 1 hour. |
| FG005 | Omafilcon A - Proclear (PC), Somofilcon A, Omafilcon A | Participants are randomized to wear omafilcon A - Proclear (PC) lens pair bilaterally for 1 hour during this double masked nondispensing fitting study, then somofilcon A, then omafilcon A lens pair bilaterally for 1 hour. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1 |
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| Day 2 |
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| Day 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | logMAR | Baseline (lens insertion), 1 hour |
|
1 hour visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omafilcon A | Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study. Omafilcon A: contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Jose A.Vega O.D., MSc., FAAO | CooperVision Inc. | 9256213761 | javega@coopervision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 13, 2017 | Mar 27, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Device |
contact lens |
|
| Omafilcon A - Proclear (PC) | Device | contact lens |
|
Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect) |
| 1 Hour |
| Lens Fit Preference | Investigator lens fit preference (Scale: omafilcon A, somofilcon A, omafilcon A - Proclear (PC)) | 1 Hour |
| Limbal Redness | Redness of limbal area (Scale: 0-4, 0 = none, 4=severe) | 1 Hour |
| Bulbar Redness | Redness of bulbar conjunctiva (Scale: 0-4, 0 = none, 4=severe) | 1 Hour |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Omafilcon A - Proclear (PC) |
Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study. Omafilcon A - Proclear (PC): contact lens |
|
|
| Primary | Comfort | Subjective comfort (Scale 0-100: 0=very uncomfortable, 100= very comfortable) | Posted | Mean | Standard Deviation | units on a scale | Insertion, 1hr |
|
|
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| Primary | Lens Centration | Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable) | Posted | Count of Participants | Participants | Insertion |
|
|
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| Primary | Lens Centration | Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable) | Posted | Count of Participants | Participants | 1 Hour |
|
|
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| Primary | Post-blink Lens Movement | Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive) | Posted | Count of Participants | Participants | Insertion |
|
|
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| Primary | Post-blink Lens Movement | Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive) | Posted | Count of Participants | Participants | 1 Hour |
|
|
|
| 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) | Posted | Count of Participants | Participants | Insertion |
|
|
|
| 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) | Posted | Count of Participants | Participants | 1 Hour |
|
|
|
| Primary | Lens Fit Preference | Investigator lens fit preference (Scale: omafilcon A, somofilcon A, omafilcon A - Proclear (PC)) | Posted | Count of Participants | Participants | 1 Hour |
|
|
|
| Primary | Limbal Redness | Redness of limbal area (Scale: 0-4, 0 = none, 4=severe) | Posted | Mean | Standard Deviation | units on a scale | 1 Hour |
|
|
|
| Primary | Bulbar Redness | Redness of bulbar conjunctiva (Scale: 0-4, 0 = none, 4=severe) | Posted | Mean | Standard Deviation | units on a scale | 1 Hour |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Somofilcon A | Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study. Somofilcon A: contact lens | 0 | 40 | 0 | 40 | 0 | 40 |
| EG002 | Omafilcon A - Proclear (PC) | Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study. Omafilcon A - Proclear (PC): contact lens | 0 | 40 | 0 | 40 | 0 | 40 |
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| Decentration Unacceptable |
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| Decentration Unacceptable |
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| Optimum |
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| Moderate |
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| Excessive |
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| Optimum |
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| Moderate |
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| Excessive |
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| Min acceptable |
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| OK to dispense |
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| Perfect |
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| Min acceptable |
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| OK to dispense |
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| Perfect |
|