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Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels

Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00940459
Enrollment
30
Registered
2009-07-16
Start date
2009-06-30
Completion date
2009-09-30
Last updated
2016-11-16

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

Conditions

Contact Lenses

Keywords

contact lenses, conjunctival staining, contact lens wear

Brief summary

The purpose of this study was to evaluate the effect of different contact lens edge designs on the circumlimbal conjunctiva.

Interventions

DEVICESenofilcon A contact lens (Acuvue Oasys)

Silicone hydrogel contact lens CE-marked for the intended usage.

DEVICEComfilcon A contact lens (Biofinity)

Silicone hydrogel contact lens CE-marked for the intended usage.

DEVICELotrafilcon B contact lens (Air Optix)

Silicone hydrogel contact lens CE-marked for the intended usage.

DEVICEBalafilcon A contact lens (PureVision)

Silicone hydrogel contact lens CE-marked for the intended usage.

DEVICEEtafilcon A contact lens (Acuvue 2)

Hydrogel contact lens CE-marked for the intended usage.

DEVICEContact lens care system (EasySept)

Contact lens care system CE-marked for the intended usage.

Sponsors

Alcon Research
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Minimum age of 18 years old * Adapted contact lens wearer * Sign informed consent * Normal eyes with the exception of the need for visual correction * Astigmatism less than or equal to -0.75 diopter * Spherical prescription range between -10.00 and +6.00 diopters * Other protocol-defined inclusion criteria may apply

Exclusion criteria

* Any known sensitivity to the test articles used in the study * Monocular vision * Lid or conjunctival infections or abnormalities * Conjunctival staining greater than Grade 1 * Corneal staining greater than Grade 2 * Corneal edema or opacifications * Aphakia * Any previous corneal surgery * Iritis * Recent significant changes in visual acuity * Ocular disease that contraindicates contact lens wear * Tarsal abnormalities greater than Grade 2 * Any ophthalmic medication * Any systemic medication or condition that might affect the subject's participation in the study * Chronic upper respiratory infections or colds * Pregnancy or planning to become pregnant * Lactation * Seasonal allergies * Known infections or immunosuppressive disease * Participation in other studies * Other protocol-defined

Design outcomes

Primary

MeasureTime frame
Circumlimbal Conjunctival Staining (CCS)After 10 days of wear

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026