Contact Lenses, Extended-WearNCT00344643
A Comparison of 12 Month Daily Wear of Two Novel O2 Permeable Silicone Hydrogel CLs (HOP/SiH) and A Control, Standard O2 Lens
A study testing Silicone Hydrogel Soft Contact Lenses in people with Contact Lenses, Extended-Wear, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this research is to compare the on-eye performance of 12 month daily wear versus 6-night extended wear and 30-night extended wear of novel hyper-oxygen permeable contact lenses by studying its effects on human eyes. Usual and customary care will be given in the form of eyeglasses and/or contact lenses. Read more about this study
- Who is it for?
- Ages 18 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Contact Lenses, Extended-Wear
- What is being tested?
- Silicone Hydrogel Soft Contact Lenses
- Type of treatment
- Medical device
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria: The age requirement for this study is between 18-38 years old. The subject has to have nearsightedness in between -1.00D and -6.00D with regular astigmatism of an amount in both eyes that will not necessitate the need for toric lenses. No prior history of any lens wear within one month of entry into the contact lens phase of the study. Visual acuity of 20/30 or better during test lens wear. Normal anatomy and physiology of the eye. No eye cosmetic use on the day of study visits. Normal appearance of the cornea with slit lamp examination, stable tear film and sufficient tear production. Intraocular pressure less than or equal to 21 mmHg by Goldmann applanation. Absence of any intraocular inflammation. Normal appearance of optic nerve, macula and peripheral retina by direct fundus examination.
Exclusion Criteria: Patients with chronic ocular conditions are excluded from the study (i.e. dry eye, recurrent corneal epithelial erosion). History of allergic eye disease either seasonal or associated with previous contact lens wear. Use of any topically applied ocular medication or systemic medication specifically including but not limited to, antihistamines, aspirin-related drugs, or psychoactive or anti-depressant medication. Oral contraceptives are allowed. Currently suspected or actual pregnancy. Study terminates if pregnancy occurs. Patients will not be enrolled if they are currently in another ophthalmic research project.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center At Dallas
Dallas, Texas, 75390
About this study
Official title: A Comparison of 12 Month Daily Wear of Two Novel Hyper-Oxygen Permeable Silicone Hydrogel Contact Lenses (HOP/SiH) and A Control, Standard Oxygen Permeable Lens; and, 30-Night Versus 6-Night Immediate Extended Wear of Two HOP/SiH Lenses.
The purpose of this research is to compare the on-eye performance of 12 month daily wear versus 6-night extended wear and 30-night extended wear of novel hyper-oxygen permeable contact lenses by studying its effects on human eyes. Usual and customary care will be given in the form of eyeglasses and/or contact lenses.
Read the detailed description
The purpose of this research is to compare the on-eye performance of 12 month daily wear versus 6-night extended wear and 30-night extended wear of novel hyper-oxygen permeable contact lenses on bacterial binding to corneal cells and central epithelial thickness. Usual and customary care will be given in the form of eyeglasses and contact lenses. To compare long-term Daily wear vs. immediate Overnight wear (Extended wear) of a new hyper-oxygen permeable silicone hydrogel contact lens on binding of Pseudomonas Aeruginosa to exfoliated human surface corneal cells collected from the eyes of human patients and on central corneal thickness, as follows: 1) a hyper Dk/t lens for 12 months of daily wear, 2) a hyper Dk/t lens for 12 months of de novo 6 night extended wear, and 3) a hyper Dk/t lens for 12 months of de novo 30 night extended wear.
- Conditions
- Contact Lenses, Extended-Wear
- Being tested
- Silicone Hydrogel Soft Contact Lenses
- Keywords
- Comparison of Daily wear versus Extended wear in bacterial binding and corneal epithelial thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone Hydrogel Soft Contact LensesDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary - Bacterial binding rates between test articles in both manners of wear - Daily wear and extended wear.
Measured: 12 Months
Secondary outcomes (1)
Secondary - Corneal Epithelial thickness measures between test articles in both manners of wear - Daily wear and extended wear.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
- Study startOct 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contact Lenses, Extended-WearStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- CIBA VISION, National Eye Institute (NEI)
- Investigators
- Harrison D Cavanagh, M.D., PhD, Principal investigator, University of Texas, Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344643
- Sponsor's protocol ID
- 0202-112
- Status last verified
- Jun 2008
- First submitted
- 23 Jun 2006
- Last updated
- 23 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Robertson DM, Petroll WM, Cavanagh HD. The effect of nonpreserved care solutions on 12 months of daily and extended silicone hydrogel contact lens wear. Invest Ophthalmol Vis Sci. 2008 Jan;49(1):7-15. doi: 10.1167/iovs.07-0940.
PubMed 18172068
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of 12 Month Daily Wear of Two Novel Hyper-Oxygen Permeable Silicone Hydrogel Contact Lenses (HOP/SiH) and A Control, Standard Oxygen Permeable Lens; and, 30-Night Versus 6-Night Immediate Extended Wear of Two HOP/SiH Lenses.
- ClinicalTrials.gov ID
- NCT00344643
- Acronym / sponsor ID
- 0202-112
- Conditions
- Contact Lenses, Extended-Wear
- Keywords
- Comparison of Daily wear versus Extended wear in bacterial binding and corneal epithelial thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- CIBA VISION, National Eye Institute (NEI)
- Study start
- Oct 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 27 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to compare the on-eye performance of 12 month daily wear versus 6-night extended wear and 30-night extended wear of novel hyper-oxygen permeable contact lenses by studying its effects on human eyes. Usual and customary care will be given in the form of eyeglasses and/or contact lenses.
Detailed description
The purpose of this research is to compare the on-eye performance of 12 month daily wear versus 6-night extended wear and 30-night extended wear of novel hyper-oxygen permeable contact lenses on bacterial binding to corneal cells and central epithelial thickness. Usual and customary care will be given in the form of eyeglasses and contact lenses. To compare long-term Daily wear vs. immediate Overnight wear (Extended wear) of a new hyper-oxygen permeable silicone hydrogel contact lens on binding of Pseudomonas Aeruginosa to exfoliated human surface corneal cells collected from the eyes of human patients and on central corneal thickness, as follows: 1) a hyper Dk/t lens for 12 months of daily wear, 2) a hyper Dk/t lens for 12 months of de novo 6 night extended wear, and 3) a hyper Dk/t lens for 12 months of de novo 30 night extended wear.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silicone Hydrogel Soft Contact Lenses | Device | – |
Primary outcome
Primary - Bacterial binding rates between test articles in both manners of wear - Daily wear and extended wear.
Time frame: 12 Months
1 secondary outcome
Secondary - Corneal Epithelial thickness measures between test articles in both manners of wear - Daily wear and extended wear.
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2008.
- Derived from this study: PubMed 18172068Robertson DM, Petroll WM, Cavanagh HD. The effect of nonpreserved care solutions on 12 months of daily and extended silicone hydrogel contact lens wear. Invest Ophthalmol Vis Sci. 2008 Jan;49(1):7-15. doi: 10.1167/iovs.07-0940.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harrison D Cavanagh, M.D., PhD principal investigator
University of Texas, Southwestern Medical Center at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silicone Hydrogel Soft Contact Lenses in people with Contact Lenses, Extended-Wear, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary - Bacterial binding rates between test articles in both manners of wear - Daily wear and extended wear. (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00344643, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2008.