A Clinical Comparison of Two Daily Disposable Contact Lenses.
2 other identifiers
interventional
123
1 country
1
Brief Summary
The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 15, 2008
CompletedFirst Posted
Study publicly available on registry
October 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedResults Posted
Study results publicly available
March 3, 2011
CompletedJune 19, 2018
May 1, 2015
5 months
October 15, 2008
February 7, 2011
June 18, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Comfort
Subjects rated study contact lens for overall comfort using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
1 week
Secondary Outcomes (4)
Inferior Region Corneal Staining
1 week
End of the Day Comfort
1 week
Initial Comfort
1 Week
Overall Lens Handling
1 week
Study Arms (2)
etafilcon A/nelfilcon A
ACTIVE COMPARATORetafilcon A contact lens worn first and nelfilcon A contact lens worn second
nelfilcon A/etafilcon A
ACTIVE COMPARATORnelfilcon A contact lens worn first and etafilcon A contact lens second.
Interventions
Eligibility Criteria
You may qualify if:
- Age: 18 years to 45 years
- Current daily soft contact lens as habitual optical correction:
- Refraction:
- Best sphere (corrected for back vertex distance) -1.00 to -6.00D
- Cylinder 0.00 to - 0.75D
- Best spectacle corrected visual acuity of 6/9 or better in each eye
- Willingness to adhere to the instructions set in the clinical protocol
- Signature of the subject on the informed consent form
You may not qualify if:
- Systemic or ocular allergies which might interfere with contact lens wear
- Systemic disease which might interfere with contact lens wear
- Ocular disease which might interfere with contact lens wear (e.g. hypoesthesia, insufficient lacrimal secretion)
- Use of medication which might interfere with contact lens wear
- Active ocular infection
- Use of ocular medication
- Significant ocular anomaly
- Presence of two or more corneal scars in either eye
- Pregnancy or lactation
- Any medical condition that might be prejudicial to the study
- Participated in any other clinical studies in the past month
- Currently wears monovision
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Otometry Technology Group, Ltd.
London, SW1E 6AU, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kurt Moody, Director Design R&D
- Organization
- Vistakon
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2008
First Posted
October 17, 2008
Study Start
August 1, 2008
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
June 19, 2018
Results First Posted
March 3, 2011
Record last verified: 2015-05