Comparative Study of Two Marketed Spherical Soft Contact Lenses
Study Details
Study Description
Brief Summary
The purpose of this study is to obtain objective and subjective clinical data to compare the performance of two soft contact lenses.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
The study will evaluate the daily wear performance of the Avaira (enfilcon A) spherical lens during two weeks of wear compared to Vistakon's Oasys (senofilcon A) spherical lens.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: enfilcon A/senofilcon A Subjects were randomized to wear enfilcon A then Senofilcon A for two weeks. |
Device: enfilcon A
enfilcon A daily wear soft contact lens
Device: senofilcon A
senofilcon A daily wear soft contact lens
|
Active Comparator: senofilcon A/enfilcon A Subjects were randomized to wear senofilcon A then enfilcon A for two weeks |
Device: enfilcon A
enfilcon A daily wear soft contact lens
Device: senofilcon A
senofilcon A daily wear soft contact lens
|
Outcome Measures
Primary Outcome Measures
- Comfort - First Intervention [Baseline]
Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt,
- Comfort - Second Intervention [Baseline]
Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt,
- Comfort - First Intervention [2 Weeks]
Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt).
- Comfort - Second Intervention [2 Weeks]
Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt).
- Comfortable Wearing Time - First Intervention [2 Weeks]
Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for first intervention at week two visit.
- Comfortable Wearing Time - Second Intervention [2 Weeks]
Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for second intervention at week two visit.
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects must satisfy the following conditions prior to inclusion in the study:
-
Based on his/her knowledge, must be in good general health.
-
Be 18 to 38 years old.
-
Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
-
Read, indicate understanding of, and sign Written Informed Consent.
-
Be existing or successfully adapted users of soft contact lenses, but not currently wearing either of the study lenses being evaluated in this trial.
-
Require a visual correction in both eyes.
-
Require a prescription between +8.00D and -12.00D and have less than -0.75D of astigmatism in both eyes.
-
Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription.
-
Must be able to wear their lenses at least 10 working days over the next 2-weeks; > 8 hours/day assuming there are no contraindications for doing so.
-
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: no amblyopia; no evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes); no clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection); no other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology); no aphakia
Exclusion Criteria:
Any of the following will render a subject ineligible for inclusion:
-
Greater than 0.50D of refractive astigmatism in either eye.
-
Presbyopic or current monovision contact lens wear.
-
Cannot be currently wearing of either lenses (Avaira or Oasys)
-
Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
-
Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear.
-
Slit lamp findings that would contraindicate contact lens wear such as: pathological dry eye or associated findings; pterygium, pinguecula or corneal scars within the visual axis; neovascularization > 0.75 mm in from the limbus, giant papillary conjunctivitis (GPC) worse than Grade 1; anterior uveitis or iritis (past or present), seborrheic eczema, seborrheic conjunctivitis, history of corneal ulcer or fungal infections; poor personal hygiene
-
A known history of corneal hypoesthesia (reduced corneal sensitivity).
-
Contact lens best corrected Snellen visual acuities (VA) worse than 20/30.
-
Aphakia, Keratoconus or a highly irregular cornea
To be eligible to enter the study, subjects must have ALL of the inclusion criteria and NONE of the exclusion criteria present.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Advanced Eyecare | Pismo Beach | California | United States | 93449 |
2 | Eric M. White, OD, Inc. | San Diego | California | United States | 92123 |
Sponsors and Collaborators
- Coopervision, Inc.
Investigators
- Study Director: Don Siegel, OD, Coopervision, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EX-MKTG-37
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Enfilcon A, Then Senofilcon A | Senofilcon A, Then Enfilcon A |
---|---|---|
Arm/Group Description | Subjects were randomized to wear enfilcon A then Senofilcon A for two weeks enfilcon A: enfilcon A daily wear soft contact lens senofilcon A: senofilcon A daily wear soft contact lens | Subjects were randomized to wear senofilcon A then enfilcon A for two weeks senofilcon A: senofilcon A daily wear soft contact lens enfilcon A: enfilcon A daily wear soft contact lens |
Period Title: First Intervention (14 Days) | ||
STARTED | 34 | 27 |
COMPLETED | 34 | 27 |
NOT COMPLETED | 0 | 0 |
Period Title: First Intervention (14 Days) | ||
STARTED | 34 | 27 |
COMPLETED | 33 | 27 |
NOT COMPLETED | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Overall Study Group Prior to Dispense |
---|---|
Arm/Group Description | All subjects prior to dispense of first set of study lenses |
Overall Participants | 61 |
Age (years) [Median (Full Range) ] | |
Median (Full Range) [years] |
30
|
Sex: Female, Male (Count of Participants) | |
Female |
45
73.8%
|
Male |
16
26.2%
|
Region of Enrollment (participants) [Number] | |
United States |
61
100%
|
Outcome Measures
Title | Comfort - First Intervention |
---|---|
Description | Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt, |
Time Frame | Baseline |
Outcome Measure Data
Analysis Population Description |
---|
one drop out at first 2 week follow up |
Arm/Group Title | Enfilcon A | Senofilcon A |
---|---|---|
Arm/Group Description | Subject wears enfilcon A daily wear soft contact lens as first pair | Subject wears senofilcon A daily wear soft contact lens as first pair |
Measure Participants | 34 | 27 |
Insertion |
9.3
(1.1)
|
9.3
(1.1)
|
Overall |
9.4
(0.9)
|
9.3
(0.9)
|
Title | Comfort - Second Intervention |
---|---|
Description | Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt, |
Time Frame | Baseline |
Outcome Measure Data
Analysis Population Description |
---|
one drop out at first 2 week follow up |
Arm/Group Title | Enfilcon A | Senofilcon A |
---|---|---|
Arm/Group Description | Subject wears enfilcon A daily wear soft contact lens as second pair | Subject wears senofilcon A daily wear soft contact lens as second pair |
Measure Participants | 27 | 33 |
Insertion |
9.1
(1.1)
|
9.1
(1.3)
|
Overall |
9.1
(1.0)
|
9.1
(0.9)
|
Title | Comfort - First Intervention |
---|---|
Description | Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt). |
Time Frame | 2 Weeks |
Outcome Measure Data
Analysis Population Description |
---|
one drop out at first 2 week follow up |
Arm/Group Title | Enfilcon A | Senofilcon A |
---|---|---|
Arm/Group Description | Subject wears enfilcon A daily wear soft contact lens as first pair | Subject wears senofilcon A daily wear soft contact lens as first pair |
Measure Participants | 34 | 27 |
Insertion |
8.5
(1.8)
|
8.3
(2.0)
|
End of day |
7.2
(2.1)
|
7.7
(1.7)
|
2 weeks wear |
7.7
(2.0)
|
7.7
(2.1)
|
Overall |
7.9
(1.7)
|
8.2
(1.8)
|
Title | Comfort - Second Intervention |
---|---|
Description | Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt). |
Time Frame | 2 Weeks |
Outcome Measure Data
Analysis Population Description |
---|
1 subject withdrew from study. |
Arm/Group Title | Enfilcon A | Senofilcon A |
---|---|---|
Arm/Group Description | Subject wears enfilcon A daily wear soft contact lens as second pair | Subject wears senofilcon A daily wear soft contact lens as second pair |
Measure Participants | 27 | 33 |
Insertion |
8.5
(1.1)
|
8.4
(1.6)
|
End of day |
6.3
(2.2)
|
7.1
(2.3)
|
2 weeks wear |
7.4
(1.8)
|
7.3
(2.4)
|
Overall |
7.2
(1.8)
|
7.6
(2.4)
|
Title | Comfortable Wearing Time - First Intervention |
---|---|
Description | Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for first intervention at week two visit. |
Time Frame | 2 Weeks |
Outcome Measure Data
Analysis Population Description |
---|
one drop out at first 2 week follow up |
Arm/Group Title | Enfilcon A | Senofilcon A |
---|---|---|
Arm/Group Description | Subject wears enfilcon A daily wear soft contact lens as first pair | Subject wears senofilcon A daily wear soft contact lens as first pair |
Measure Participants | 33 | 27 |
Mean (Standard Deviation) [hours] |
11.5
(3.5)
|
10.7
(3.2)
|
Title | Comfortable Wearing Time - Second Intervention |
---|---|
Description | Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for second intervention at week two visit. |
Time Frame | 2 Weeks |
Outcome Measure Data
Analysis Population Description |
---|
one drop out at first 2 week follow up |
Arm/Group Title | Enfilcon A | Senofilcon A |
---|---|---|
Arm/Group Description | Subject wears enfilcon A daily wear soft contact lens as second pair | Subject wears senofilcon A daily wear soft contact lens as second pair |
Measure Participants | 27 | 33 |
Mean (Standard Deviation) [hours] |
10.1
(3.0)
|
11
(3.9)
|
Adverse Events
Time Frame | From dispense up to 2 weeks for each intervention | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Enfilcon A/Senofilcon A | Senofilcon A/Enfilcon A | ||
Arm/Group Description | enfilcon A daily wear soft contact lens 1st then cross over and subject wears the senofilcon A daily wear soft contact lens 2nd enfilcon A: enfilcon A daily wear soft contact lens senofilcon A: senofilcon A daily wear soft contact lens | senofilcon A daily wear soft contact lens 1st then cross over and subject wears the enfilcon A daily wear soft contact lens 2nd enfilcon A: enfilcon A daily wear soft contact lens senofilcon A: senofilcon A daily wear soft contact lens | ||
All Cause Mortality |
||||
Enfilcon A/Senofilcon A | Senofilcon A/Enfilcon A | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Enfilcon A/Senofilcon A | Senofilcon A/Enfilcon A | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/34 (0%) | 0/27 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Enfilcon A/Senofilcon A | Senofilcon A/Enfilcon A | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/34 (0%) | 0/27 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor. Assuming that the product is marketed, it is the intention of the sponsor to publish the results of the study.
Results Point of Contact
Name/Title | Don Siegel, OD |
---|---|
Organization | CooperVision, US |
Phone | 623-544-3877 |
dsiegel@coopervision.com |
- EX-MKTG-37