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This purpose of this study is to compare the clinical performance and subjective acceptance of two different daily disposable limbal ring lenses.
This is a subject-masked, dispensing study designed to evaluate the clinical performance and subjective acceptance when comparing two different daily disposable limbal ring lenses. Limbal ring lenses, which as well as correcting vision, have a colored ring which enhance the wearer's iris and are particularly popular in East Asian countries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hema-copolymer Lens | Active Comparator | Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. |
|
| etafilcon A Lens | Active Comparator | Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hema-copolymer Lens | Device | contact lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity - Hema-copolymer and Etafilcon A | Visual acuity measured by logMAR of hema-copolymer and etafilcon A lenses assessed at baseline. | Baseline |
| Visual Acuity - Hema-copolymer and Etafilcon A | Visual acuity measured by logMAR for hema-copolymer and etafilcon A lenses assessed at 1 week. | 1 week |
| Biomicroscopy - Hema-copolymer and Etafilcon A | Biomicroscopy is analyzed for hema-copolymer and etafilcon A at 1 week. (Scale 0-4, 0=normal, 4=severe). | 1 week |
| Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits. | Baseline |
| Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits. | 1 week |
| Lens Surface - Debris - Hema-copolymer and Etafilcon A | Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens. |
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Inclusion Criteria:
Subjects will only be eligible for the study if:
Exclusion Criteria:
Subjects will not be able to take part in the study if:
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| Name | Affiliation | Role |
|---|---|---|
| Carole Maldonado-Codinal, PhD | Eurolens Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research - The University of Manchester | Manchester | M13 9PL | United Kingdom |
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Thirty subjects were dispensed lenses, and nineteen subjects successfully wore both study products.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hema-copolymer Lens, Then Etafilcon A Lens | Participants were randomized to wear the Hema-copolymer lens pair for one week then cross over to the etafilcon A lens pair. |
| FG001 | Etafilcon A Lens, Then Hema-copoloymer Lens | Participants were randomized to wear the etafilcon A lens pair for one week then cross over to the Hema-copolymer lens lens pair. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (7 Days) |
| |||||||||||||
| Second Intervention (7 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Baseline Characteristics | Randomized to wear the Hema-copolymer lens pair or the etafilcon A lens pair for one week then cross over to the alternate pair Hema-copolymer Lens: Hema-copolymer lens pair or the Etafilcon A lens pair etafilcon A Lens: Hema-copolymer lens pair or the Etafilcon A lens pair |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 - Hema-copolymer and Etafilcon A | Visual acuity measured by logMAR of hema-copolymer and etafilcon A lenses assessed at baseline. | All 30 subjects were dispensed lenses, and visual acuity measurements were obtained at baseline. | Posted | Mean | Standard Deviation | logMAR | Baseline |
|
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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 | Hema-copolymer Lens | Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Hema-copolymer: contact lens |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unilateral red eye | Eye disorders | Unilateral red eye on removal of the hema-copolymer lens. Symptoms resolved overnight and normal wear was resumed the next day. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Chamberlain, BSc Honors, Sr. Manager Clinical Research | Coopervision | (925) 730-6754 | pchamberlain@coopervision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| etafilcon A Lens |
| Device |
contact lens |
|
| Baseline |
| Lens Surface - Debris - Hema-copolymer and Etafilcon A | Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens. | 1 week |
| Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Lens surface of wettability for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas. | Baseline |
| Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Lens surface of wettability for hema-copolymer and etafilcon A pair lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas. | 1 week |
| Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal | Baseline |
| Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal | 1 week |
| Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior | Baseline |
| Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior | 1 week |
| Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive | Baseline |
| Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive | 1 week |
| Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive | Baseline |
| Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive | 1 week |
| Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective Assessment of comfort preference for hema-copolymer and etafilcon A assessed at baseline. Scale 0-100, 0=causes pain, 100= excellent. | Baseline |
| Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective Assessment of comfort preference after insertion and before removal for hema-copolymer and etafilcon A lenses is assessed at 1 week. Scale 0-100, 0=causes pain, 100= excellent. | 1 week |
| Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent. | Baseline |
| Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent. | 1 week |
| Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective Assessment of peripheral blur is assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent. | Baseline |
| Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective Assessment of peripheral blur assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent. | 1 week |
| Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective Assessment of ocular redness for hema-copolymer and etafilcon A lenses lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent. | 1 week |
| Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective Assessment of handling (ease of insertion and ease of removal) for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unmanageable, 100= excellent. | 1 week |
| Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent. | Baseline |
| Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent. | 1 week |
| Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent. | Baseline |
| Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent. | 1 week |
| NOT COMPLETED |
|
|
| years |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Visual Acuity - Hema-copolymer and Etafilcon A | Visual acuity measured by logMAR for hema-copolymer and etafilcon A lenses assessed at 1 week. | 11 subjects discontinued the study. Missing data of 1 subject for hema-copolymer group. | Posted | Mean | Standard Deviation | logMAR | 1 week |
|
|
|
| Primary | Biomicroscopy - Hema-copolymer and Etafilcon A | Biomicroscopy is analyzed for hema-copolymer and etafilcon A at 1 week. (Scale 0-4, 0=normal, 4=severe). | 11 subjects discontinued the study. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Primary | Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits. | All 30 subjects were dispensed lenses, and lens surface of deposition measurements were obtained at baseline. | Posted | Number | participants | Baseline |
|
|
|
| Primary | Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits. | 11 subjects discontinued the study. | Posted | Number | participants | 1 week |
|
|
|
| Primary | Lens Surface - Debris - Hema-copolymer and Etafilcon A | Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens. | All 30 subjects were dispensed lenses, and lens surface of debris measurements were obtained at baseline. | Posted | Number | participants | Baseline |
|
|
|
| Primary | Lens Surface - Debris - Hema-copolymer and Etafilcon A | Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens. | 11 subjects discontinued the study. | Posted | Number | participants | 1 week |
|
|
|
| Primary | Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Lens surface of wettability for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas. | All 30 subjects were dispensed lenses, and lens surface of wettability measurements were obtained at baseline. | Posted | Number | participants | Baseline |
|
|
|
| Primary | Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Lens surface of wettability for hema-copolymer and etafilcon A pair lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas. | 11 subjects discontinued the study. | Posted | Number | participants | 1 week |
|
|
|
| Primary | Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal | All 30 subjects were dispensed lenses, and lens fit of horizontal centration measurements were obtained at baseline. | Posted | Number | Eyes | Baseline | Eyes | Eyes |
|
|
|
| Primary | Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal | 11 subjects discontinued the study. | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
|
|
| Primary | Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior | All 30 subjects were dispensed lenses, and lens fit of vertical centration measurements were obtained at baseline. | Posted | Number | Eyes | Baseline | Eyes | Eyes |
|
|
|
| Primary | Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior | 11 subjects discontinued the study. | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
|
|
| Primary | Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive | All 30 subjects were dispensed lenses, and lens fit of corneal centration measurements were obtained at baseline. | Posted | Number | Eyes | Baseline | Eyes | Eyes |
|
|
|
| Primary | Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive | 11 subjects discontinued the study. | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
|
|
| Primary | Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive | All 30 subjects were dispensed lenses, and lens movement measurements were obtained at baseline. | Posted | Number | Eyes | Baseline | Eyes | Eyes |
|
|
|
| Primary | Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive | 11 subjects discontinued the study. | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
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| Primary | Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective Assessment of comfort preference for hema-copolymer and etafilcon A assessed at baseline. Scale 0-100, 0=causes pain, 100= excellent. | 7 subjects discontinued the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective Assessment of comfort preference after insertion and before removal for hema-copolymer and etafilcon A lenses is assessed at 1 week. Scale 0-100, 0=causes pain, 100= excellent. | 11 subjects discontinued the study. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Primary | Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent. | 8 subjects discontinued the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent. | 11 subjects discontinued the study. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
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|
| Primary | Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective Assessment of peripheral blur is assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent. | 8 subjects discontinued the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective Assessment of peripheral blur assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent. | 11 subjects discontinued the study. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Primary | Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective Assessment of ocular redness for hema-copolymer and etafilcon A lenses lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent. | 11 subjects discontinued the study. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Primary | Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective Assessment of handling (ease of insertion and ease of removal) for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unmanageable, 100= excellent. | 11 subjects discontinued the study. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Primary | Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent. | 8 subjects discontinued the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent. | 11 subjects discontinued the study. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Primary | Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent. | 8 subjects discontinued the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A | Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent. | 11 subjects discontinued the study. Missing data of 1 subject for hema-copolymer group. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| 0 |
| 19 |
| 1 |
| 19 |
| EG001 | Etafilcon A Lens | Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. etafilcon A lens: contact lens | 0 | 19 | 0 | 19 |
|
There IS an agreement between the Principal Investigator and the Sponsor that restricts the PI's right to discuss or publish trial results after the trial is completed without prior approval of Sponsor.
The investigator will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
| Limbal hyperameia |
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| Corneal vascularisation |
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| Microcysts |
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| Oedema |
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| Corenal Staining |
|
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| Conjunctival Staining |
|
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| Papillary Conjunctivitis |
|
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Optimum |
|
| Slightly Temporal |
|
| Extremely Temporal |
|
| Optimum |
|
| Slightly Temporal |
|
| Extremely Temporal |
|
| Optimum |
|
| Slightly Superior |
|
| Extremely Superior |
|
| Optimum |
|
| Slightly Superior |
|
| Extremely Superior |
|
| Optimum |
|
| Slightly Excessive |
|
| Extremely Excessive |
|
| Optimum |
|
| Slightly Excessive |
|
| Extremely Excessive |
|
| Optimum |
|
| Slightly Excessive |
|
| Extremely Excessive |
|
| Optimum |
|
| Slightly Excessive |
|
| Extremely Excessive |
|
| Overall comfort |
|
| Variable vision |
|