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Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses

Primary Purpose

Astigmatism

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

enfilcon A

senofilcon A

About this trial

This is an interventional other trial for Astigmatism

Eligibility Criteria

18 Years - 38 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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 (Avaira or Oasys) 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 or equal to 0.75D of astigmatism in both eyes.
Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription.
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:

0.75D or greater of refractive astigmatism in either eye.
Presbyopic or current monovision contact lens wear.
Cannot be currently wearing either lenses (Avaira or Oasys).
Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammation 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.

Sites / Locations

Schaeffer Eye Associates
Beaches Family Eyecare
Todays Eyecare, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

enfilcon A

senofilcon A

Arm Description

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

Outcomes

Primary Outcome Measures

Comfort at Insertion

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

Comfort at Insertion

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

Comfort Preference

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

Comfort Preference

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02356692

First Posted

April 30, 2012

Last Updated

October 30, 2020

Sponsor

Coopervision, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02356692

Brief Title

Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses

Official Title

Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Coopervision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Astigmatism

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

enfilcon A

Arm Type

Experimental

Arm Description

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

Arm Title

senofilcon A

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

enfilcon A

Intervention Description

Test lens

Intervention Type

Device

Intervention Name(s)

senofilcon A

Intervention Description

Control lens

Primary Outcome Measure Information:

Title

Comfort at Insertion

Description

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

Time Frame

Baseline

Title

Comfort at Insertion

Description

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

Time Frame

15 minutes

Title

Comfort Preference

Description

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

Time Frame

Baseline

Title

Comfort Preference

Description

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

Time Frame

15 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

38 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 (Avaira or Oasys) 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 or equal to 0.75D of astigmatism in both eyes. Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription. 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: 0.75D or greater of refractive astigmatism in either eye. Presbyopic or current monovision contact lens wear. Cannot be currently wearing either lenses (Avaira or Oasys). Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammation 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donald Siegel, OD

Organizational Affiliation

Coopervision, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Schaeffer Eye Associates

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35216

Country

United States

Facility Name

Beaches Family Eyecare

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Todays Eyecare, LLC

City

Lafayette

State/Province

Louisiana

ZIP/Postal Code

70503

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses

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