Myopia
Conditions
Brief summary
To determine if patients are unreactive to the lens care solution / Biofinity combination.
Detailed description
To determine if patients are unreactive to the lens care solution / Biofinity combination in this cross-over study.
Interventions
OTHERBioclean First Care EX / comfilcon A
Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the alternate combination.
OTHERAosept Clearcare / comfilcon A
Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the alternate combination.
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is over 18 years of age (inclusive) * Has had a self-reported visual exam in the last two years * Is currently an adapted spherical soft CL wearer * Has a CL spherical prescription between - 0.25 and - 12.00 (inclusive) * Has less than 1.00D spectacle cylinder in each eye. * Is correctable to a visual acuity of 20/20 or better in both eyes * Has clear corneas and no active ocular disease * Has read, understood and signed the information consent letter. * Is willing to comply with the wear schedule (at least 40 hrs per week) * Is willing to comply with the visit schedule
Exclusion criteria
* 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 - 0.25 to -12.00D * Has a spectacle cylinder greater than -0.75D of cylinder in either eye. * Has best corrected spectacle distance vision worse than 20/20 in either eye. * Has any systemic disease affecting ocular health. * Is using any systemic or topical medications that will affect ocular health. * Has any ocular pathology or severe insufficiency of lacrimal secretion * Has persistent, clinically significant corneal or conjunctival staining * Has active neovascularization or any central corneal scars. * Is aphakic. * Is pregnant or lactating. * Has undergone corneal refractive surgery. * Is participating in any other type of eye related clinical or research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Health - Corneal Staining | 1 week | Corneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe). |
| Ocular Health - Conjunctival Redness | 1 week | Conjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe). |
| Ocular Health - Limbal Redness | 1 week | Limbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe). |
| Ocular Health - Papillary Conjunctivitis | 1 week | Papillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stinging Sensation Right After Insertion (Subjective Rating) | Baseline | Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all). |
| Burning Sensation Right After Insertion (Subjective Rating) | Baseline | Subjective rating of burning sensation right after insertion for each combination assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all). |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bioclean First Care EX / Aosept Clearcare / Comfil Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Bioclean First Care EX / Aosept Clearcare / Comfil |
|---|---|
| Age, Continuous | 31 years STANDARD_DEVIATION 7.4 |
| Region of Enrollment Japan | 30 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Ocular Health - Conjunctival Redness
Conjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bioclean First Care EX / Comfilcon A | Ocular Health - Conjunctival Redness | Trace | 20 Eyes |
| Bioclean First Care EX / Comfilcon A | Ocular Health - Conjunctival Redness | Moderate | 0 Eyes |
| Bioclean First Care EX / Comfilcon A | Ocular Health - Conjunctival Redness | Mild | 0 Eyes |
| Bioclean First Care EX / Comfilcon A | Ocular Health - Conjunctival Redness | Severe | 0 Eyes |
| Bioclean First Care EX / Comfilcon A | Ocular Health - Conjunctival Redness | Normal | 40 Eyes |
| Aosept Clearcare / Comfilcon A | Ocular Health - Conjunctival Redness | Severe | 0 Eyes |
| Aosept Clearcare / Comfilcon A | Ocular Health - Conjunctival Redness | Normal | 40 Eyes |
| Aosept Clearcare / Comfilcon A | Ocular Health - Conjunctival Redness | Trace | 20 Eyes |
| Aosept Clearcare / Comfilcon A | Ocular Health - Conjunctival Redness | Mild | 0 Eyes |
| Aosept Clearcare / Comfilcon A | Ocular Health - Conjunctival Redness | Moderate | 0 Eyes |
Primary
Ocular Health - Corneal Staining
Corneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bioclean First Care EX / Comfilcon A | Ocular Health - Corneal Staining | Trace | 18 Eyes |
| Bioclean First Care EX / Comfilcon A | Ocular Health - Corneal Staining | Moderate | 0 Eyes |
| Bioclean First Care EX / Comfilcon A | Ocular Health - Corneal Staining | Mild | 4 Eyes |
| Bioclean First Care EX / Comfilcon A | Ocular Health - Corneal Staining | Severe | 0 Eyes |
| Bioclean First Care EX / Comfilcon A | Ocular Health - Corneal Staining | Normal | 38 Eyes |
| Aosept Clearcare / Comfilcon A | Ocular Health - Corneal Staining | Severe | 0 Eyes |
| Aosept Clearcare / Comfilcon A | Ocular Health - Corneal Staining | Normal | 35 Eyes |
| Aosept Clearcare / Comfilcon A | Ocular Health - Corneal Staining | Trace | 20 Eyes |
| Aosept Clearcare / Comfilcon A | Ocular Health - Corneal Staining | Mild | 5 Eyes |
| Aosept Clearcare / Comfilcon A | Ocular Health - Corneal Staining | Moderate | 0 Eyes |
Primary
Ocular Health - Limbal Redness
Limbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bioclean First Care EX / Comfilcon A | Ocular Health - Limbal Redness | Normal | 49 Eyes |
| Bioclean First Care EX / Comfilcon A | Ocular Health - Limbal Redness | Mild | 0 Eyes |
| Bioclean First Care EX / Comfilcon A | Ocular Health - Limbal Redness | Trace | 11 Eyes |
| Bioclean First Care EX / Comfilcon A | Ocular Health - Limbal Redness | Severe | 0 Eyes |
| Bioclean First Care EX / Comfilcon A | Ocular Health - Limbal Redness | Moderate | 0 Eyes |
| Aosept Clearcare / Comfilcon A | Ocular Health - Limbal Redness | Severe | 0 Eyes |
| Aosept Clearcare / Comfilcon A | Ocular Health - Limbal Redness | Moderate | 0 Eyes |
| Aosept Clearcare / Comfilcon A | Ocular Health - Limbal Redness | Normal | 47 Eyes |
| Aosept Clearcare / Comfilcon A | Ocular Health - Limbal Redness | Trace | 12 Eyes |
| Aosept Clearcare / Comfilcon A | Ocular Health - Limbal Redness | Mild | 1 Eyes |
Primary
Ocular Health - Papillary Conjunctivitis
Papillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bioclean First Care EX / Comfilcon A | Ocular Health - Papillary Conjunctivitis | Trace | 7 Eyes |
| Bioclean First Care EX / Comfilcon A | Ocular Health - Papillary Conjunctivitis | Moderate | 0 Eyes |
| Bioclean First Care EX / Comfilcon A | Ocular Health - Papillary Conjunctivitis | Mild | 1 Eyes |
| Bioclean First Care EX / Comfilcon A | Ocular Health - Papillary Conjunctivitis | Severe | 0 Eyes |
| Bioclean First Care EX / Comfilcon A | Ocular Health - Papillary Conjunctivitis | Normal | 52 Eyes |
| Aosept Clearcare / Comfilcon A | Ocular Health - Papillary Conjunctivitis | Severe | 0 Eyes |
| Aosept Clearcare / Comfilcon A | Ocular Health - Papillary Conjunctivitis | Normal | 51 Eyes |
| Aosept Clearcare / Comfilcon A | Ocular Health - Papillary Conjunctivitis | Trace | 8 Eyes |
| Aosept Clearcare / Comfilcon A | Ocular Health - Papillary Conjunctivitis | Mild | 1 Eyes |
| Aosept Clearcare / Comfilcon A | Ocular Health - Papillary Conjunctivitis | Moderate | 0 Eyes |
Secondary
Burning Sensation Right After Insertion (Subjective Rating)
Subjective rating of burning sensation right after insertion for each combination assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bioclean First Care EX / Comfilcon A | Burning Sensation Right After Insertion (Subjective Rating) | 9.5 units on a scale | Standard Deviation 1.1 |
| Aosept Clearcare / Comfilcon A | Burning Sensation Right After Insertion (Subjective Rating) | 9.4 units on a scale | Standard Deviation 1.2 |
Secondary
Stinging Sensation Right After Insertion (Subjective Rating)
Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bioclean First Care EX / Comfilcon A | Stinging Sensation Right After Insertion (Subjective Rating) | 9.5 units on a scale | Standard Deviation 1.1 |
| Aosept Clearcare / Comfilcon A | Stinging Sensation Right After Insertion (Subjective Rating) | 9.4 units on a scale | Standard Deviation 1.2 |