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This study aimed to compare the clinical performance of two daily disposable toric contact lenses.
This was a multi-center, randomized, participant-masked, bilateral study controlled by cross-comparison. Participants were assigned to either lens type in random sequence. Lenses were worn on a daily disposable wear schedule. Follow-up visits for each lens were performed after 1 week of wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens A, then Lens B | Experimental | Participants wore Lens A for one week, then crossed over to wear Lens B for one week. |
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| Lens B, then Lens A | Experimental | Participants wore Lens B for one week, then crossed over to wear Lens A for one week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens A (delefilcon A) | Device | Daily disposable for one week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Handling Rating on Lens Removal | Subjective handling rating on lens removal was measured on a scale of 0-100 where 0=Unmanageable and 100=Excellent removal. | One week |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Lens Fit at Follow-up | Lens fit was reported as either optimum, acceptable, or unacceptable. To determine this, lens fit parameters (horizontal centration, vertical centration, corneal coverage, and lens movement) were measured on a 5-point scale (-2 to +2), where -2=Extremely nasal, 0=Optimum, and +2=Extremely temporal. Scores between -1 and +1 were considered "Acceptable". For overall lens fit to be 'acceptable', no parameters could be extreme. For a score to be 'optimum', all parameters needed to be optimum. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Morgan | Eurolens Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cameron Optometry | Edinburgh | Edinburg | EH3 6SW | United Kingdom | ||
| Simon Falk Eyecare |
Five participants were initially ineligible, but were re-enrolled following a protocol amendment that expanded the age range and allowed the use of an increased range of lens axes for Lens A.
A total of 55 participants were dispensed study lenses, and 54 completed the study. Five participants discontinued the study prior to dispensing and were therefore not included in either the enrollment count or data analysis population. Nine participants were ineligible.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lens A (Delefilcon A), Then Lens B (Stenfilcon A) | Participants wore Lens A for one week, then crossed over to wear Lens B for one week. |
| FG001 | Lens B (Stenfilcon A), Then Lens A (Delefilcon A) | Participants wore Lens B for one week, then crossed over to wear Lens A for one week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (One Week) |
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| Period 2 (One Week) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All participants who were dispensed lenses and successfully completed the study. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Subjective Handling Rating on Lens Removal | Subjective handling rating on lens removal was measured on a scale of 0-100 where 0=Unmanageable and 100=Excellent removal. | Lens A: all data for one participant was discounted, as the follow-up visit took place significantly outside the date range for this visit. Lens B: all data for a different participant was discounted, as the follow-up visit took place significantly outside the date range for this visit. Another participant's subjective scores and symptoms were not collected at the correct study visit in error, and their data was subsequently excluded from analysis. | Posted | Mean | Standard Deviation | units on a scale | One week |
|
The duration of the study, approximately 2 weeks per participant.
There was 1 significant ocular adverse event and 1 non-significant ocular adverse event in 2 separate participants that occurred while wearing their habitual lens.
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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 | Lens A | Participants that received Lens A during either the first or second period of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Swelling of Eyelid | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Global Clinical Affairs | CooperVision Inc. | +19256213761 | jvega2@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 | Feb 3, 2023 | Nov 27, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Lens B (stenfilcon A) | Device | Daily disposable for one week |
|
| One Week |
| Biomicroscopy Score at Follow-up | Slit lamp biomicroscopy was used to assign grades to various biomicroscopic signs, as assessed by investigator, using Efron Grading Scales scored to the nearest 0.1 unit. Grading ranged from 0-4, where 0=None and 4=Severe. | One week |
| Oakwood |
| Leeds |
| LS8 2HU |
| United Kingdom |
| Phipps Opticians | Heckmondwike | WF16 0EZ | United Kingdom |
| NOT COMPLETED |
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| years |
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| 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 |
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| OG001 |
| Lens B |
Participants that received Lens B during either the first or second period of the study. |
|
|
| Secondary | Overall Lens Fit at Follow-up | Lens fit was reported as either optimum, acceptable, or unacceptable. To determine this, lens fit parameters (horizontal centration, vertical centration, corneal coverage, and lens movement) were measured on a 5-point scale (-2 to +2), where -2=Extremely nasal, 0=Optimum, and +2=Extremely temporal. Scores between -1 and +1 were considered "Acceptable". For overall lens fit to be 'acceptable', no parameters could be extreme. For a score to be 'optimum', all parameters needed to be optimum. | Lens A: all data for one participant was discounted, as the follow-up visit took place significantly outside the date range for this visit. Lens B: all data for a different participant was discounted, as the follow-up visit took place significantly outside the date range for this visit. | Posted | Count of Participants | Participants | One Week |
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|
|
| Secondary | Biomicroscopy Score at Follow-up | Slit lamp biomicroscopy was used to assign grades to various biomicroscopic signs, as assessed by investigator, using Efron Grading Scales scored to the nearest 0.1 unit. Grading ranged from 0-4, where 0=None and 4=Severe. | Lens A: all data for one participant was discounted, as the follow-up visit took place significantly outside the date range for this visit. Lens B: all data for a different participant was discounted, as the follow-up visit took place significantly outside the date range for this visit. For parameter 'mucin balls', data from an additional participant was not collected in error. | Posted | Mean | Standard Deviation | score on a scale | One week |
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| 5 |
| 54 |
| EG001 | Lens B | Participants that received Lens B during either the first or second period of the study. | 0 | 54 | 0 | 54 | 1 | 54 |
| Eye Redness | Eye disorders | Systematic Assessment |
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| Corneal Scar | Eye disorders | Systematic Assessment |
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| Corneal Abrasion | Eye disorders | Systematic Assessment |
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| Conjunctival Redness | Eye disorders | Systematic Assessment | Possibly due to mechanical irritation. |
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| Unacceptable |
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| Conjunctival hyperaemia |
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| Corneal vascularisation |
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| Corneal oedema |
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| Corneal staining |
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| Conjunctival staining |
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| Papillary conjunctivitis |
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| Blepharitis |
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| Meibomian gland dysfunction |
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| Mucin balls |
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