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Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses

NCT ID: NCT02356692

Last Updated: 2020-11-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-05-31

Brief Summary

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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

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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.

Conditions

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Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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enfilcon A

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

Group Type EXPERIMENTAL

enfilcon A

Intervention Type DEVICE

Test lens

senofilcon A

Intervention Type DEVICE

Control lens

senofilcon A

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

Group Type ACTIVE_COMPARATOR

enfilcon A

Intervention Type DEVICE

Test lens

senofilcon A

Intervention Type DEVICE

Control lens

Interventions

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enfilcon A

Test lens

Intervention Type DEVICE

senofilcon A

Control lens

Intervention Type DEVICE

Eligibility Criteria

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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)
7. Contact Lens best corrected Snellen visual acuities (VA) worse than 20/30.
8. Aphakia, Keratoconus or a highly irregular cornea.
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CooperVision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donald Siegel, OD

Role: STUDY_CHAIR

CooperVision, Inc.

Locations

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Schaeffer Eye Associates

Birmingham, Alabama, United States

Site Status

Beaches Family Eyecare

Jacksonville, Florida, United States

Site Status

Todays Eyecare, LLC

Lafayette, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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EX-MKTG-38-MTF

Identifier Type: -

Identifier Source: org_study_id