Status:
COMPLETED
Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels
Lead Sponsor:
Alcon Research
Conditions:
Contact Lenses
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study was to evaluate the effect of different contact lens edge designs on the circumlimbal conjunctiva.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00940459
Start Date
June 1 2009
End Date
September 1 2009
Last Update
November 16 2016
Active Locations (1)
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1
Optometric Technology Group Ltd
London, United Kingdom