Comparative Study of Two Marketed Spherical Soft Contact Lenses

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01582789
Collaborator
(none)
61
2
2
3.7
30.5
8.2

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
  • Device: enfilcon A
  • Device: senofilcon A
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

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of CooperVision's Avaira Spherical Daily Wear Soft Contact Lens Versus Vistakon's Oasys Spherical Daily Wear Soft Contact Lens
Study Start Date :
Apr 9, 2012
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
Jul 31, 2012

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

  1. 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,

  2. 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,

  3. 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).

  4. 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).

  5. 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.

  6. 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

Ages Eligible for Study:
18 Years to 38 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Responsible Party:
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01582789
Other Study ID Numbers:
  • EX-MKTG-37
First Posted:
Apr 23, 2012
Last Update Posted:
Oct 27, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

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

1. Primary Outcome
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)
2. Primary Outcome
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)
3. Primary Outcome
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)
4. Primary Outcome
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)
5. Primary Outcome
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)
6. Primary Outcome
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

[Not Specified]

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
Email dsiegel@coopervision.com
Responsible Party:
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01582789
Other Study ID Numbers:
  • EX-MKTG-37
First Posted:
Apr 23, 2012
Last Update Posted:
Oct 27, 2020
Last Verified:
Oct 1, 2020