Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
The purpose of this trial was to compare the performance of an investigational daily disposable contact lens to a commercially available daily disposable contact lens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2011
Shorter than P25 for not_applicable
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, 2011
CompletedFirst Submitted
Initial submission to the registry
May 27, 2011
CompletedFirst Posted
Study publicly available on registry
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
August 3, 2012
CompletedAugust 3, 2012
June 1, 2012
1 month
May 27, 2011
June 28, 2012
June 28, 2012
Conditions
Outcome Measures
Primary Outcomes (4)
Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)
As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity.
1 week of wear, replacing lenses daily
Overall Comfort
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
1 week of wear, replacing lenses daily
Overall Vision Quality
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
1 week of wear, replacing lenses daily
Overall Handling
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy.
1 week of wear, replacing lenses daily
Secondary Outcomes (1)
Overall Lens Fit
1 week of wear, replacing lenses daily
Study Arms (2)
Delefilcon A / etafilcon A
OTHERDelefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Etafilcon A / delefilcon A
OTHEREtafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Interventions
Investigational, silicone hydrogel, single vision, soft contact lens for daily disposable wear
Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear
Eligibility Criteria
You may qualify if:
- Normal eyes with no use of ocular medications.
- Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
- Willing and able to wear spherical contact lenses for protocol-specified timeframe within the available range of powers (-1.00 D to -6.00D in 0.25D steps).
- Visual acuity with study lenses 20/25 or better.
- Cylinder less than or equal to 0.75 D.
- Currently wearing daily disposable lenses.
You may not qualify if:
- Anterior segment infection, inflammation, or abnormality.
- Any active anterior segment ocular disease that would contraindicate contact lens wear.
- Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
- History of refractive surgery or irregular cornea.
- Eye injury within twelve weeks immediately prior to enrollment for this trial.
- Currently enrolled in any clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CIBA VISIONlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joachim Nick, Dipl. Ing. (FH)
- Organization
- Alcon Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2011
First Posted
June 1, 2011
Study Start
May 1, 2011
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
August 3, 2012
Results First Posted
August 3, 2012
Record last verified: 2012-06