Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02356692
Collaborator
(none)
60
Enrollment
3
Locations
2
Arms
30
Duration (Days)
20
Patients Per Site
20.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to investigate the overall clinical comfort performance of enfilcon A (test) lens and senofilcon A (control) lens over 15-minutes of lens wear.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: enfilcon A
  • Device: senofilcon A
N/A

Detailed Description

This was a non-dispensing, single-masked, randomized, contralateral study comparing Enfilcon A (test) against Senofilcon A (control). Each subject was randomized to wear the test lens in one eye and the control lens in the other eye.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses
Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

ArmIntervention/Treatment
Experimental: enfilcon A

participants randomized to wear the Enfilcon A (test) lens in one eye and Senofilcon A (control) lens in the other eye.

Device: enfilcon A
Test lens

Device: senofilcon A
Control lens

Active Comparator: senofilcon A

participants randomized to wear the Enfilcon A (test) lens in one eye and Senofilcon A (control) lens in the other eye.

Device: enfilcon A
Test lens

Device: senofilcon A
Control lens

Outcome Measures

Primary Outcome Measures

  1. Comfort at Insertion [Baseline]

    Participant's response for comfort at insertion. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at baseline.

  2. Comfort at Insertion [15 minutes]

    Participant's response for comfort at 15 minutes. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at 15 minutes.

  3. Comfort Preference [Baseline]

    Participant's response for comfort preference of enfilcon A (test) lens, senofilcon A(control) lens at insertion.

  4. Comfort Preference [15 minutes]

    Participant's response for comfort of enfilcon A (test) lens, senofilcon A (control) lens at 15 minutes wear.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 38 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Based on his/her knowledge, must be in good general health.

  2. Be 18 to 38 years old.

  3. Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.

  4. Read, indicate understanding of, and sign Written Informed Consent.

  5. Be existing or successfully adapted users of soft contact lenses, but not currently wearing either of the study lenses (Avaira or Oasys) being evaluated in this trial.

  6. Require a visual correction in both eyes.

  7. Require a prescription between +8.00D and -12.00D and have less than or equal to 0.75D of astigmatism in both eyes.

  8. Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription.

  9. 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).

  • 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:
  1. 0.75D or greater of refractive astigmatism in either eye.

  2. Presbyopic or current monovision contact lens wear.

  3. Cannot be currently wearing either lenses (Avaira or Oasys).

  4. Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammation such as iritis; or any infection of the eye, lids, or associated structures.

  5. Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear.

  6. 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)

  1. Contact Lens best corrected Snellen visual acuities (VA) worse than 20/30.

  2. Aphakia, Keratoconus or a highly irregular cornea.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Schaeffer Eye AssociatesBirminghamAlabamaUnited States35216
2Beaches Family EyecareJacksonvilleFloridaUnited States32256
3Todays Eyecare, LLCLafayetteLouisianaUnited States70503

Sponsors and Collaborators

  • Coopervision, Inc.

Investigators

  • Study Chair: Donald Siegel, OD, Coopervision, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT02356692
Other Study ID Numbers:
  • EX-MKTG-38-MTF
First Posted:
Feb 5, 2015
Last Update Posted:
Nov 23, 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 TitleEnfilcon ASenofilcon A
Arm/Group Descriptionparticipants randomized to wear the (enfilcon A) test lens in one eye. Enfilcon A: contact lensparticipants randomized to wear the senofilcon A contact lens (control) in the one eye. Senofilcon A: contact lens
Period Title: Overall Study
STARTED6060
COMPLETED6060
NOT COMPLETED00

Baseline Characteristics

Arm/Group TitleOverall Study Group
Arm/Group Descriptionparticipants randomized to wear the (enfilcon A) test lens in one eye and the senofilcon A (control) in the other eye.
Overall Participants60
Age (Count of Participants)
<=18 years
0
0%
Between 18 and 65 years
60
100%
>=65 years
0
0%
Sex: Female, Male (Count of Participants)
Female
43
71.7%
Male
17
28.3%
Region of Enrollment (participants) [Number]
United States
60
100%

Outcome Measures

1. Primary Outcome
TitleComfort at Insertion
DescriptionParticipant's response for comfort at insertion. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at baseline.
Time FrameBaseline

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleEnfilcon ASenofilcon A
Arm/Group Descriptionparticipants randomized to wear the (enfilcon A) test lens in one eye. enfilcon A: contact lensparticipants randomized to wear the senofilcon A (control) lens in the one eye. senofilcon A: contact lens
Measure Participants6060
Measure eyes6060
Mean (Standard Deviation) [units on a scale]
8.7
(1.6)
8.5
(1.7)
2. Primary Outcome
TitleComfort at Insertion
DescriptionParticipant's response for comfort at 15 minutes. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at 15 minutes.
Time Frame15 minutes

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleEnfilcon ASenofilcon A
Arm/Group Descriptionparticipants randomized to wear the (enfilcon A) test lens in one eye. enfilcon A: contact lensparticipants randomized to wear the senofilcon A control lens in one eye. senofilcon A: contact lens
Measure Participants6060
Measure Eyes6060
Mean (Standard Deviation) [units on a scale]
8.1
(1.8)
8.7
(1.3)
3. Primary Outcome
TitleComfort Preference
DescriptionParticipant's response for comfort preference of enfilcon A (test) lens, senofilcon A(control) lens at insertion.
Time FrameBaseline

Outcome Measure Data

Analysis Population Description
n=59, one participant would not choose a preference at the initial insertion as both lenses were the same to them.
Arm/Group TitleOverall Study Group
Arm/Group Descriptionparticipants randomized to wear the (enfilcon A) test lens in one eye and the senofilcon A (control) in the other eye. Enfilcon A: contact lens Senofilcon A: contact lens
Measure Participants59
Prefer Enfilcon A
30
50%
Prefer Senofilcon A
29
48.3%
4. Primary Outcome
TitleComfort Preference
DescriptionParticipant's response for comfort of enfilcon A (test) lens, senofilcon A (control) lens at 15 minutes wear.
Time Frame15 minutes

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleOverall Study Group
Arm/Group Descriptionparticipants randomized to wear the (enfilcon A) test lens in one eye and the senofilcon A (control) in the other eye. Enfilcon A: contact lens Senofilcon A: contact lens
Measure Participants60
Preferred Enfilcon A
25
41.7%
Preferred Senofilcon A
35
58.3%

Adverse Events

Time FrameFrom dispense up to 15 minutes for both study lenses.
Adverse Event Reporting Description
Arm/Group TitleEnfilcon ASenofilcon A
Arm/Group Descriptionparticipants randomized to wear the test lens (enfilcon A) in one eye. Enfilcon A: contact lensparticipants randomized to wear the control lens (senofilcon A) in the one eye. Senofilcon A: contact lens
All Cause Mortality
Enfilcon ASenofilcon A
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/60 (0%) 0/60 (0%)
Serious Adverse Events
Enfilcon ASenofilcon A
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/60 (0%) 0/60 (0%)
Other (Not Including Serious) Adverse Events
Enfilcon ASenofilcon A
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/60 (0%) 0/60 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Recipient agress to maintain Confidential Information in strict confidence, not to disclose Confidential Information to any third parties and no to use Confidential Information for any purposes execpt for Business Purpose.

Results Point of Contact

Name/TitleDonald Siegel, OD
OrganizationCooperVision
Phone602 485 3414
Emaildsiegel@coopervision.com
Responsible Party:
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT02356692
Other Study ID Numbers:
  • EX-MKTG-38-MTF
First Posted:
Feb 5, 2015
Last Update Posted:
Nov 23, 2020
Last Verified:
Oct 1, 2020