Clinical Comparison of Two Daily Disposable Lenses Among Daily Disposable Lens Wearers
1 other identifier
interventional
316
1 country
1
Brief Summary
The primary objective of this trial is to evaluate the subjective performance of two different daily disposable contact lenses in a population of daily disposable lens wearers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2010
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
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 27, 2010
CompletedFirst Posted
Study publicly available on registry
May 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedNovember 21, 2016
October 1, 2011
2 months
May 27, 2010
November 17, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
subjective ratings and preferences
2 weeks
Study Arms (2)
nelfilcon A / filcon II 3
OTHERNelfilcon A contact lenses worn first, with filcon II 3 contact lenses worn second. Both products worn in both eyes on a daily wear, daily disposable basis for one week each.
filcon II 3 / nelfilcon A
OTHERFilcon II 3 contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn in both eyes on a daily wear, daily disposable basis for one week each.
Interventions
Commercially marketed, single-vision, soft contact lens for daily disposable wear
Commercially marketed, single-vision, soft contact lens for daily disposable wear
Eligibility Criteria
You may qualify if:
- Currently wearing any spherical daily disposable lens in daily wear, daily disposable modality for at least 3 months prior to enrollment with the exception of the 2 study products
- Currently Wearing lenses at least 8 hrs/day and 5 days/week.
You may not qualify if:
- Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in any clinical trial.
- Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
- Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
- Prior history of corneal or refractive surgery.
- Requires monovision correction.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CIBA VISIONlead
Study Sites (1)
W.Hartwig - Qualität in jeder Hinsicht
Heikendorf, 24226, Germany
Related Publications (1)
OVS, Marx et al. Subjective Performance of hydrogel and silicone hydrogel daily disposable contact lenses). AAO poster presentation 2014.
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
May 27, 2010
First Posted
May 31, 2010
Study Start
May 1, 2010
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
November 21, 2016
Record last verified: 2011-10