The Clinical Evaluation of Two Daily Disposable Contact Lenses
This study has been completed.
Sponsor:
Vistakon
Collaborator:
Eurolens Research
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00762996
First received: September 26, 2008
Last updated: November 14, 2011
Last verified: November 2011
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Purpose
The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.
| Condition | Intervention |
|---|---|
|
Myopia |
Device: etafilcon A Device: omafilcon A |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Vistakon:
Primary Outcome Measures:
- Distance Visual Acuity [ Time Frame: 1 week ] [ Designated as safety issue: No ]logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Secondary Outcome Measures:
- Lens Comfort [ Time Frame: 1 week ] [ Designated as safety issue: No ]A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.>0 = comfortable, <0 = uncomfortable
| Enrollment: | 65 |
| Study Start Date: | August 2007 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: etafilcon A/etafilcon A
Period 1: etafilcon A, Period 2: etafilcon A
|
Device: etafilcon A
contact lens
|
|
Active Comparator: etafilcon A/omafilcon A
Period 1: etafilcon A, Period 2: omafilcon A
|
Device: etafilcon A
contact lens
Device: omafilcon A
contact lens
|
|
Active Comparator: omafilcon A/etafilcon A
Period 1: omafilcon A, Period 2: etafilcon A
|
Device: etafilcon A
contact lens
Device: omafilcon A
contact lens
|
|
Active Comparator: omafilcon A/omafilcon A
Period 1: omafilcon A, Period 2: omafilcon A
|
Device: omafilcon A
contact lens
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- They are of legal age (18 years) and capacity to volunteer.
- They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They would be expected to attain at least 6.9 (20/30) in each eye with the study lenses.
- They are able to wear contact lenses which have a back vertex power of -1.00 to -6.00DS.
- They have a maximum of 1.00D of refractive astigmatism (i.e. < 1.00 DC).
- They have worn soft contact lenses within six months of starting the study.
Exclusion Criteria:
- They have an ocular disorder which would normally contra-indicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are using any topical medication such as eye drops or ointment.
- They are aphakic.
- They have had corneal refractive surgery.
- They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
- They are pregnant or lactating.
- They have grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
- They have any infectious disease (e.g., hepatitis) or any immunosuppressive disease (e.g., HIV).
- They have diabetes.
- They are currently taking part in any other clinical study or research.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Vistakon |
| ClinicalTrials.gov Identifier: | NCT00762996 History of Changes |
| Other Study ID Numbers: | CR-0707 |
| Study First Received: | September 26, 2008 |
| Results First Received: | October 24, 2008 |
| Last Updated: | November 14, 2011 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Myopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on May 21, 2013