Myopia
Conditions
Brief summary
This study was a multi-site, prospective, randomized, non-masked, unilateral, non-dispensing study.
Detailed description
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.
Interventions
OTHERControl
No lens
DEVICETest Lens
Low Dk HEMA contact lens worn for 3 hours
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Is between 17 and 60 years of age inclusive (age matching required between all 3 study groups), and has full legal capacity to volunteer; 2. Has had a self-reported oculo-visual examination in the last two years. 3. Has read and signed an information consent letter; 4. Is willing and able to follow instructions and maintain the appointment schedule; 5. No previous history of overnight contact lens wear or PMMA (polymethylmethacrylate) lens wear. 6. 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. 7. 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. 8. 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. 9. 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. 10. Has clear and healthy corneas and anterior eye and no active ocular disease; 11. Can achieve monocular HCVA of logMAR 0.10 or better in each eye with subjective refraction or pinhole. 12. 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. 13. Has a wearable pair of spectacles.
Exclusion criteria
1. Is participating in any concurrent clinical trial; 2. Is unable/unwilling to provide permission for the study site to seek CL history from their eye care practitioner 3. Has any known active ocular disease and/or infection; 4. Has a systemic condition that in the opinion of the investigator may affect a study measure or interfere with contact lens wear; this may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, Stevens-Johnson syndromes, and systemic connective tissue disorders e.g. rheumatoid arthritis. 5. Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure; 6. Has known sensitivity to fluorescein dye, topical anesthetic, or products to be used in the study; 7. Appears to have any active ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses; 8. Appears to have any signs of corneal inflammation or previous infection or corneal opacity/scar; 9. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit), due to potential ocular physiological changes, such as changes in the corneal shape and cell types; 10. Is aphakic; 11. Has undergone refractive error surgery, or has a history of any ocular surgery or injury. 12. Is a toric or multifocal contact lens wearer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Limbal Redness - DDSH, DDH, Non-lens Groups | 6-8 hours of habitual wear | 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). |
| Bulbar Redness DDSH, DDH, Non-lens Groups | 6-8 hours of habitual wear | 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). |
| Limbal Vessel Ingrowth - DDSH, DDH, Non-lens Groups | 6-8 hours of habitual wear | 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. |
| Limbal Redness - DDSH, DDH Groups | Immediately upon eye opening (t=baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removal | 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. |
| Bulbar Redness - DDSH, DDH Groups | Immediately upon eye opening (baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removal | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central Corneal Swelling (%) - DDSH, DDH Groups | 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 | 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. |
Countries
Canada, United Kingdom
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| DDSH Lens Wearers Participants who habitually wear DDSH lenses | 10 |
| DDH Lens Wearers Participants who habitually wear DDH lenses | 3 |
| Non-lens Wearers Participants that do not wear either DDSH or DDH Lens. | 9 |
| Total | 22 |
Baseline characteristics
| Characteristic | DDSH Lens Wearers | DDH Lens Wearers | Non-lens Wearers | Total |
|---|---|---|---|---|
| Age, Continuous | 32.7 years STANDARD_DEVIATION 13.2 | 30.0 years STANDARD_DEVIATION 7.5 | 31.7 years STANDARD_DEVIATION 13.2 | 31.9 years STANDARD_DEVIATION 12.2 |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Non-Asian | 10 Participants | 3 Participants | 9 Participants | 22 Participants |
| Sex: Female, Male Female | 5 Participants | 2 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 5 Participants | 1 Participants | 3 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 3 | 0 / 9 |
| other Total, other adverse events | 0 / 10 | 0 / 3 | 1 / 9 |
| serious Total, serious adverse events | 0 / 10 | 0 / 3 | 0 / 9 |
Outcome results
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.
Time frame: Immediately upon eye opening (baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removal
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DDSH Lens Wearers | Bulbar Redness - DDSH, DDH Groups | T, t=baseline | 0.87 score on a scale |
| DDSH Lens Wearers | Bulbar Redness - DDSH, DDH Groups | T, t=0 hour | 1.00 score on a scale |
| DDSH Lens Wearers | Bulbar Redness - DDSH, DDH Groups | T, t=1 hours | 0.89 score on a scale |
| DDSH Lens Wearers | Bulbar Redness - DDSH, DDH Groups | T, t=3 hours | 1.03 score on a scale |
| DDSH Lens Wearers | Bulbar Redness - DDSH, DDH Groups | N, t=baseline | 0.78 score on a scale |
| DDSH Lens Wearers | Bulbar Redness - DDSH, DDH Groups | N, t=0 hour | 1.14 score on a scale |
| DDSH Lens Wearers | Bulbar Redness - DDSH, DDH Groups | N, t=1 hours | 1.00 score on a scale |
| DDSH Lens Wearers | Bulbar Redness - DDSH, DDH Groups | N, t=3 hours | 1.21 score on a scale |
| DDH Lens Wearers | Bulbar Redness - DDSH, DDH Groups | N, t=3 hours | 0.77 score on a scale |
| DDH Lens Wearers | Bulbar Redness - DDSH, DDH Groups | T, t=baseline | 0.60 score on a scale |
| DDH Lens Wearers | Bulbar Redness - DDSH, DDH Groups | N, t=baseline | 0.80 score on a scale |
| DDH Lens Wearers | Bulbar Redness - DDSH, DDH Groups | T, t=0 hour | 0.63 score on a scale |
| DDH Lens Wearers | Bulbar Redness - DDSH, DDH Groups | N, t=1 hours | 0.73 score on a scale |
| DDH Lens Wearers | Bulbar Redness - DDSH, DDH Groups | T, t=1 hours | 0.57 score on a scale |
| DDH Lens Wearers | Bulbar Redness - DDSH, DDH Groups | N, t=0 hour | 0.87 score on a scale |
| DDH Lens Wearers | Bulbar Redness - DDSH, DDH Groups | T, t=3 hours | 0.60 score on a scale |
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).
Time frame: 6-8 hours of habitual wear
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DDSH Lens Wearers | Bulbar Redness DDSH, DDH, Non-lens Groups | OD, T | 0.76 score on a scale |
| DDSH Lens Wearers | Bulbar Redness DDSH, DDH, Non-lens Groups | OD, N | 0.86 score on a scale |
| DDSH Lens Wearers | Bulbar Redness DDSH, DDH, Non-lens Groups | OS, T | 0.93 score on a scale |
| DDSH Lens Wearers | Bulbar Redness DDSH, DDH, Non-lens Groups | OS, N | 0.86 score on a scale |
| DDH Lens Wearers | Bulbar Redness DDSH, DDH, Non-lens Groups | OS, N | 0.60 score on a scale |
| DDH Lens Wearers | Bulbar Redness DDSH, DDH, Non-lens Groups | OD, T | 0.67 score on a scale |
| DDH Lens Wearers | Bulbar Redness DDSH, DDH, Non-lens Groups | OS, T | 0.73 score on a scale |
| DDH Lens Wearers | Bulbar Redness DDSH, DDH, Non-lens Groups | OD, N | 0.83 score on a scale |
| Non-lens Wearers | Bulbar Redness DDSH, DDH, Non-lens Groups | OS, N | 0.67 score on a scale |
| Non-lens Wearers | Bulbar Redness DDSH, DDH, Non-lens Groups | OD, N | 0.71 score on a scale |
| Non-lens Wearers | Bulbar Redness DDSH, DDH, Non-lens Groups | OS, T | 0.80 score on a scale |
| Non-lens Wearers | Bulbar Redness DDSH, DDH, Non-lens Groups | OD, T | 0.79 score on a scale |
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.
Time frame: Immediately upon eye opening (t=baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removal
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DDSH Lens Wearers | Limbal Redness - DDSH, DDH Groups | T, t=baseline | 0.48 score on a scale |
| DDSH Lens Wearers | Limbal Redness - DDSH, DDH Groups | T, t=0 hour | 0.70 score on a scale |
| DDSH Lens Wearers | Limbal Redness - DDSH, DDH Groups | T, t=1 hours | 0.61 score on a scale |
| DDSH Lens Wearers | Limbal Redness - DDSH, DDH Groups | T, t=3 hours | 0.71 score on a scale |
| DDSH Lens Wearers | Limbal Redness - DDSH, DDH Groups | N, t=baseline | 0.36 score on a scale |
| DDSH Lens Wearers | Limbal Redness - DDSH, DDH Groups | N, t=0 hour | 0.72 score on a scale |
| DDSH Lens Wearers | Limbal Redness - DDSH, DDH Groups | N, t=1 hours | 0.57 score on a scale |
| DDSH Lens Wearers | Limbal Redness - DDSH, DDH Groups | N, t=3 hours | 0.63 score on a scale |
| DDH Lens Wearers | Limbal Redness - DDSH, DDH Groups | N, t=3 hours | 0.43 score on a scale |
| DDH Lens Wearers | Limbal Redness - DDSH, DDH Groups | T, t=baseline | 0.33 score on a scale |
| DDH Lens Wearers | Limbal Redness - DDSH, DDH Groups | N, t=baseline | 0.50 score on a scale |
| DDH Lens Wearers | Limbal Redness - DDSH, DDH Groups | T, t=0 hour | 0.43 score on a scale |
| DDH Lens Wearers | Limbal Redness - DDSH, DDH Groups | N, t=1 hours | 0.57 score on a scale |
| DDH Lens Wearers | Limbal Redness - DDSH, DDH Groups | T, t=1 hours | 0.43 score on a scale |
| DDH Lens Wearers | Limbal Redness - DDSH, DDH Groups | N, t=0 hour | 0.63 score on a scale |
| DDH Lens Wearers | Limbal Redness - DDSH, DDH Groups | T, t=3 hours | 0.30 score on a scale |
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).
Time frame: 6-8 hours of habitual wear
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DDSH Lens Wearers | Limbal Redness - DDSH, DDH, Non-lens Groups | OD, T | 0.41 score on a scale |
| DDSH Lens Wearers | Limbal Redness - DDSH, DDH, Non-lens Groups | OD, N | 0.49 score on a scale |
| DDSH Lens Wearers | Limbal Redness - DDSH, DDH, Non-lens Groups | OS, T | 0.54 score on a scale |
| DDSH Lens Wearers | Limbal Redness - DDSH, DDH, Non-lens Groups | OS, N | 0.32 score on a scale |
| DDH Lens Wearers | Limbal Redness - DDSH, DDH, Non-lens Groups | OS, N | 0.37 score on a scale |
| DDH Lens Wearers | Limbal Redness - DDSH, DDH, Non-lens Groups | OD, T | 0.37 score on a scale |
| DDH Lens Wearers | Limbal Redness - DDSH, DDH, Non-lens Groups | OS, T | 0.30 score on a scale |
| DDH Lens Wearers | Limbal Redness - DDSH, DDH, Non-lens Groups | OD, N | 0.40 score on a scale |
| Non-lens Wearers | Limbal Redness - DDSH, DDH, Non-lens Groups | OS, N | 0.41 score on a scale |
| Non-lens Wearers | Limbal Redness - DDSH, DDH, Non-lens Groups | OD, N | 0.44 score on a scale |
| Non-lens Wearers | Limbal Redness - DDSH, DDH, Non-lens Groups | OS, T | 0.46 score on a scale |
| Non-lens Wearers | Limbal Redness - DDSH, DDH, Non-lens Groups | OD, T | 0.44 score on a scale |
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.
Time frame: 6-8 hours of habitual wear
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DDSH Lens Wearers | Limbal Vessel Ingrowth - DDSH, DDH, Non-lens Groups | 2 Participants |
| DDH Lens Wearers | Limbal Vessel Ingrowth - DDSH, DDH, Non-lens Groups | 2 Participants |
| Non-lens Wearers | Limbal Vessel Ingrowth - DDSH, DDH, Non-lens Groups | 0 Participants |
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DDSH Lens Wearers | Central Corneal Swelling (%) - DDSH, DDH Groups | t=0.5 hours | 7.68 Percent change in corneal swelling (%) |
| DDSH Lens Wearers | Central Corneal Swelling (%) - DDSH, DDH Groups | t=2 hours | 0.98 Percent change in corneal swelling (%) |
| DDSH Lens Wearers | Central Corneal Swelling (%) - DDSH, DDH Groups | t=1 hour | 5.17 Percent change in corneal swelling (%) |
| DDSH Lens Wearers | Central Corneal Swelling (%) - DDSH, DDH Groups | t=3 hours | -0.41 Percent change in corneal swelling (%) |
| DDSH Lens Wearers | Central Corneal Swelling (%) - DDSH, DDH Groups | t=0 hours | 9.67 Percent change in corneal swelling (%) |
| DDH Lens Wearers | Central Corneal Swelling (%) - DDSH, DDH Groups | t=3 hours | -0.45 Percent change in corneal swelling (%) |
| DDH Lens Wearers | Central Corneal Swelling (%) - DDSH, DDH Groups | t=0 hours | 9.34 Percent change in corneal swelling (%) |
| DDH Lens Wearers | Central Corneal Swelling (%) - DDSH, DDH Groups | t=0.5 hours | 6.82 Percent change in corneal swelling (%) |
| DDH Lens Wearers | Central Corneal Swelling (%) - DDSH, DDH Groups | t=1 hour | 4.26 Percent change in corneal swelling (%) |
| DDH Lens Wearers | Central Corneal Swelling (%) - DDSH, DDH Groups | t=2 hours | 0.45 Percent change in corneal swelling (%) |