Comparative Study of Two Marketed Spherical Soft Contact Lenses

Clinical Evaluation of CooperVision's Avaira Spherical Daily Wear Soft Contact Lens Versus Vistakon's Oasys Spherical Daily Wear Soft Contact Lens

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01582789

Enrollment

Registered

2012-04-23

Start date

2012-04-09

Completion date

2012-07-31

Last updated

2020-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractive Error

Brief summary

The purpose of this study is to obtain objective and subjective clinical data to compare the performance of two soft contact lenses.

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.

Interventions

DEVICEenfilcon A

enfilcon A daily wear soft contact lens

DEVICEsenofilcon A

senofilcon A daily wear soft contact lens

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 38 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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,
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Overall Study Group Prior to Dispense All subjects prior to dispense of first set of study lenses	61
Total	61

Withdrawals & dropouts

Period	Reason	FG000	FG001
Second Intervention (14 Days)	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Overall Study Group Prior to Dispense
Age, Continuous	30 years
Region of Enrollment United States	61 participants
Sex: Female, Male Female	45 Participants
Sex: Female, Male Male	16 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 34	0 / 27
serious Total, serious adverse events	0 / 34	0 / 27

Outcome results

Primary

Comfortable Wearing Time - First Intervention

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