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This study was a multi-site, prospective, randomized, non-masked, unilateral, non-dispensing study.
The purpose of this study was to to compare physiological response baseline data between 3 groups - habitual wearers of Daily Disposable Silicone Hydrogel (DDSH) contact lenses, habitual wearers of Daily Disposable Hydrogel (DDH) contact lenses, and non-lens wearers. The study then compared physiological response data following wear of a low Dk HEMA contact lens between habitual wearers of DDSH and habitual wearers of DDH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily Disposable Silicone Hydrogel Contact Lens Wearers | Experimental | Participants wore Test Lens for 3 hours |
|
| Daily Disposable Hydrogel Contact Lens Wearers | Experimental | Participants wore Test Lens for 3 hours |
|
| Non-lens Wearers | Active Comparator | Participants did not receive Test Lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Other | No lens |
| |
| Test Lens |
| Measure | Description | Time Frame |
|---|---|---|
| Limbal Redness - DDSH, DDH, Non-lens Groups | Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of limbal redness after 6-8 hours of habitual device wear. For each participant, measurements were taken for both eyes (OD - right eye, OS - left eye) at two locations (T - temporal, N - nasal). | 6-8 hours of habitual wear |
| Bulbar Redness DDSH, DDH, Non-lens Groups | Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of bulbar redness after 6-8 hours of habitual device wear. For each participant, measurements were taken for both eyes (OD - right eye, OS - left eye) at two locations (T - temporal, N - nasal). | 6-8 hours of habitual wear |
| Limbal Vessel Ingrowth - DDSH, DDH, Non-lens Groups | Number of participants with limbal vessel ingrowth longer than 0.50 mm at any of the 4 corneal quadrants (superior, inferior, nasal, temporal) after 6-8 hours of device wear. | 6-8 hours of habitual wear |
| Limbal Redness - DDSH, DDH Groups | Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of limbal redness by location (T - temporal, N - nasal) and time (t). Measurements were taken at baseline and over a 3 hour period of closed-eye Test Lens wear. | Immediately upon eye opening (t=baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removal |
| Bulbar Redness - DDSH, DDH Groups | Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of bulbar redness by location (T - temporal, N - nasal) and time (t). Measurements were taken at baseline and over a 3 hour period of closed-eye Test Lens wear. | Immediately upon eye opening (baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removal |
| Measure | Description | Time Frame |
|---|---|---|
| Central Corneal Swelling (%) - DDSH, DDH Groups | Difference in central corneal swelling (μm, Visante OCT) at baseline (before lens insertion) vs. measurements taken over a 3 hour period following Test Lens removal. Derived by the formula: corneal swelling % = (measured corneal thickness - baseline corneal thickness) x 100 /baseline corneal thickness. | Immediately upon eye opening and lens removal (t=0), 0.5 hours (t=0.5), 1 hour (t=1), 2 hours (t=2), and 3 hours (t=3) post lens removal |
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Inclusion Criteria:
Is between 17 and 60 years of age inclusive (age matching required between all 3 study groups), and has full legal capacity to volunteer;
Has had a self-reported oculo-visual examination in the last two years.
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
No previous history of overnight contact lens wear or PMMA (polymethylmethacrylate) lens wear.
Auto-refraction vertexed spherical equivalent between +4.00 and -8.00 (prescription matching required between groups 1 & 2). This criterion is non-applicable to participants in group 3.
Is found to be in one of the study groups matched by age (±5 years), ethnicity (Asian vs. non-Asian) and CL Rx (±2.00 D) according using the following criteria.
GROUP 1: For the past (minimum) 6 months has ONLY worn spherical DDSH lenses AND prior to wearing this lens they only wore SH material lenses in the past (minimum) 3 total years.
GROUP 2: For the past (minimum) 6 months has ONLY worn spherical DDH lenses AND prior to wearing this lens they only wore H material lenses in the past (minimum) 3 total years.
For groups 1 & 2, currently and for at least the previous 6 months has had habitual daily disposable wear schedule of at least 8 hrs a day, 5 days a week in only one material category - either silicone hydrogel or hydrogel material. This criterion is not-applicable to participants in group 3.
Is willing to wear the study contact lens in the randomized eye for 3 hours of eye closure on the second study day. This criterion is not-applicable to participants in group 3.
Has clear and healthy corneas and anterior eye and no active ocular disease;
Can achieve monocular HCVA of logMAR 0.10 or better in each eye with subjective refraction or pinhole.
Can achieve acceptable fit and comfort in the randomized eye with the study lens. This criterion will be confirmed at the baseline visit (V1). This criterion is not-applicable to participants in group 3.
Has a wearable pair of spectacles.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones, PhD FCOptom | Centre for Ocular Research & Education | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CORE, University of Waterloo | Waterloo | Canada | ||||
| Eurolens Research |
Twenty-six participants were screened, with 3 of these not meeting all eligibility criteria and were considered screen failures. One participant withdrew for reasons unrelated to the study. These participants were not included in the total number of participants enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | DDSH Lens Wearers | Participants wore habitual DDSH Lens in both eyes for 6-8 hours (Period 1, observational). Afterwards, participants wore the Test Lens in one randomized eye that was kept closed and patched for 3 hours (Period 2, interventional). |
| FG001 | DDH Lens Wearers | Participants wore habitual DDH Lens in both eyes for 6-8 hours (Period 1, observational). Afterwards, participants wore the Test Lens in one randomized eye that was kept closed and patched for 3 hours (Period 2, interventional). |
| FG002 | Non-lens Wearers | Participants had no previous history of contact lens wear. Participants wore habitual spectacles, if any, for 6-8 hours (Period 1, observational). They did not receive the Test Lens and were not involved in Period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Habitual Device, 6-8 Hours |
| |||||||||||||
| Period 2: Test Lens, 3 Hours |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DDSH Lens Wearers | Participants who habitually wear DDSH lenses |
| BG001 | DDH Lens Wearers | Participants who habitually wear DDH lenses |
| 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 | Limbal Redness - DDSH, DDH, Non-lens Groups | Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of limbal redness after 6-8 hours of habitual device wear. For each participant, measurements were taken for both eyes (OD - right eye, OS - left eye) at two locations (T - temporal, N - nasal). | Posted | Mean | 95% Confidence Interval | score on a scale | 6-8 hours of habitual wear | Eyes (single) | Eyes (single) |
|
Through study exit, up to 30 days from the first 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 | DDSH Lens Wearers | Participants that wore DDSH Lens in Period 1 and Test Lens in Period 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lightheadedness | Eye disorders | Systematic Assessment | Transitional feeling of light-headedness during confocal microscopy. Unrelated to study, as neither DDH Lens nor DDSH Lens were worn at time of event. |
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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 | Nov 28, 2020 | Oct 5, 2023 | 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 |
Low Dk HEMA contact lens worn for 3 hours |
|
| Manchester |
| United Kingdom |
| NOT COMPLETED |
|
| BG002 | Non-lens Wearers | Participants that do not wear either DDSH or DDH Lens. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Ethnicity was measured due to possible differences in physiological response to corneal hypoxia in Asian and non-Asian participants. All subjects in this study were of non-Asian ethnicity, due to difficulty in finding and recruiting Asian candidates at the study site. | Count of Participants | Participants |
|
| OG002 |
| Non-lens Wearers |
Participants did not wear either DDSH or DDH Lens |
|
|
| Primary | Bulbar Redness DDSH, DDH, Non-lens Groups | Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of bulbar redness after 6-8 hours of habitual device wear. For each participant, measurements were taken for both eyes (OD - right eye, OS - left eye) at two locations (T - temporal, N - nasal). | Posted | Mean | 95% Confidence Interval | score on a scale | 6-8 hours of habitual wear | Eyes (single) | Eyes (single) |
|
|
|
| Primary | Limbal Vessel Ingrowth - DDSH, DDH, Non-lens Groups | Number of participants with limbal vessel ingrowth longer than 0.50 mm at any of the 4 corneal quadrants (superior, inferior, nasal, temporal) after 6-8 hours of device wear. | Posted | Count of Participants | Participants | 6-8 hours of habitual wear |
|
|
|
| Primary | Limbal Redness - DDSH, DDH Groups | Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of limbal redness by location (T - temporal, N - nasal) and time (t). Measurements were taken at baseline and over a 3 hour period of closed-eye Test Lens wear. | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately upon eye opening (t=baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removal | Eyes (single) | Eyes (single) |
|
|
|
| Primary | Bulbar Redness - DDSH, DDH Groups | Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of bulbar redness by location (T - temporal, N - nasal) and time (t). Measurements were taken at baseline and over a 3 hour period of closed-eye Test Lens wear. | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately upon eye opening (baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removal | Eyes (single) | Eyes (single) |
|
|
|
| Secondary | Central Corneal Swelling (%) - DDSH, DDH Groups | Difference in central corneal swelling (μm, Visante OCT) at baseline (before lens insertion) vs. measurements taken over a 3 hour period following Test Lens removal. Derived by the formula: corneal swelling % = (measured corneal thickness - baseline corneal thickness) x 100 /baseline corneal thickness. | Posted | Mean | 95% Confidence Interval | Percent change in corneal swelling (%) | Immediately upon eye opening and lens removal (t=0), 0.5 hours (t=0.5), 1 hour (t=1), 2 hours (t=2), and 3 hours (t=3) post lens removal | Eyes (single) | Eyes (single) |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | DDH Lens Wearers | Participants that wore DDH Lens in Period 1 and Test Lens in Period 2 | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | Non-lens Wearers | Participants that did not wear DDSH or DDH Lenses in Period 1 | 0 | 9 | 0 | 9 | 1 | 9 |
|
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| OS, T |
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| OS, N |
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| T, t=1 hours |
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| T, t=3 hours |
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| N, t=baseline |
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| N, t=0 hour |
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| N, t=1 hours |
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| N, t=3 hours |
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| T, t=1 hours |
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| T, t=3 hours |
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| N, t=baseline |
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| N, t=0 hour |
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| N, t=1 hours |
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| N, t=3 hours |
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| t=1 hour |
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| t=2 hours |
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| t=3 hours |
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