Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels

Contact Lenses Clinical Trial

Official title:

Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940459
• Other study ID #: M-09-11
• Status: Completed
• Phase: N/A
• First received: July 14, 2009
• Last updated: November 15, 2016
• Start date: June 2009
• Est. completion date: September 2009

Study information

• Verified date: July 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Contact Lenses

Intervention

Device:
• Senofilcon A contact lens (Acuvue Oasys)
Silicone hydrogel contact lens CE-marked for the intended usage.
• Comfilcon A contact lens (Biofinity)
Silicone hydrogel contact lens CE-marked for the intended usage.
• Lotrafilcon B contact lens (Air Optix)
Silicone hydrogel contact lens CE-marked for the intended usage.
• Balafilcon A contact lens (PureVision)
Silicone hydrogel contact lens CE-marked for the intended usage.
• Etafilcon A contact lens (Acuvue 2)
Hydrogel contact lens CE-marked for the intended usage.
• Contact lens care system (EasySept)
Contact lens care system CE-marked for the intended usage.

Locations

Country	Name	City	State
United Kingdom	Optometric Technology Group Ltd	London

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Maïssa C, Guillon M, Garofalo RJ. Contact lens-induced circumlimbal staining in silicone hydrogel contact lenses worn on a daily wear basis. Eye Contact Lens. 2012 Jan;38(1):16-26. doi: 10.1097/ICL.0b013e31823bad46. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circumlimbal Conjunctival Staining (CCS)		After 10 days of wear	No