Corneal Epithelial PermeabilityPhase 4EW23NCT03139812
Daily Irrigation With Silicone Hydrogel Contact Lens Continuous Wear
A Phase 4 study testing Daily irrigation and 30-day SiH CW in people with Corneal Epithelial Permeability, run by University of California, Berkeley.
Trial summary
This study sought to determine whether daily irrigation with sterile saline solution during silicone hydrogel (SiH) contact lens continuous wear (CW) could improve ocular surface integrity and reduce the risk of adverse events. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Epithelial Permeability
- What is being tested?
- Daily irrigation and 30-day SiH CW
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2012to 15 Oct 2012
- Phase
- Phase 4
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- spectacle prescriptions between -1.00 diopter sphere (DS) and -10.00 DS;
- less than 0.75 diopters (D) of astigmatism;
- free of any ocular disease or systemic disease with ocular manifestation;
Who cannot join
- history of contact lens wear within the past year;
- history of ocular surgery or serious injury;
- presence of corneal scarring;
- frequent swimming, smoking, or use of medications w/ ocular side effects;
About this study
Official title: Effects of Daily Irrigation on Corneal Epithelial Permeability and Adverse Events With Silicone Hydrogel Contact Lens Continuous Wear
This study sought to determine whether daily irrigation with sterile saline solution during silicone hydrogel (SiH) contact lens continuous wear (CW) could improve ocular surface integrity and reduce the risk of adverse events.
Read the detailed description
The purpose of this study was to determine whether daily irrigation with sterile saline solution during silicone hydrogel (SiH) contact lens 30-day continuous wear (CW) can mitigate increases in corneal epithelial permeability (Pdc) and reduce the risk of mechanical, contact lens-induced, inflammatory, and overall adverse events. 161 non-contact lens wearers were fit with SiH contact lenses and randomized to either a treatment (n = 81) or control (n = 80) group for 30-day CW. Subjects in the treatment group irrigated every morning and whenever dryness symptoms occurred; subjects in the control group did not.
- Conditions
- Corneal Epithelial Permeability
- Being tested
- Daily irrigation, 30-day SiH CW
- Keywords
- continuous contact lens wear, silicone hydrogel contact lenses, irrigation, corneal epithelial permeability, contact lens-related adverse events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily irrigationDrug
Also called Unisol 4 (Alcon Laboratories, Inc., Fort Worth, TX)
Daily morning irrigation of the eye with sterile, borate-buffered, saline solution (Unisol 4) and gentle nudging of the lens to promote solution flow beneath the lens
30-day SiH CWDevice
30-day continuous wear of silicone hydrogel contact lenses
| Study group | Role | What they receive |
|---|---|---|
| 30-day SiH CW, No Daily Irrigation | Other | Control group subjects wore SiH lenses for 30-day CW under normal clinical practice guidelines with no daily morning irrigation of the eyes with sterile saline solution Receives: Device: 30-day SiH CW |
| 30-day SiH CW, Daily Irrigation | Other | Treatment group subjects wore SiH lenses for 30-day CW under normal clinical practice guidelines, and also irrigated the eyes with sterile saline solution every morning upon awakening Receives: Drug: Daily irrigation; Device: 30-day SiH CW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal epithelial permeability (Pdc) at Baseline
Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec at baseline with no contact lenses
Measured: Baseline
Corneal epithelial permeability (Pdc) Post-1-Day CW
Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec after 1 night of contact lens CW
Measured: Post-1-Day CW of SiH contact lenses
Corneal epithelial permeability (Pdc) Post-30-Day CW
Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec after 30 nights of contact lens CW
Measured: Post-30-Day CW of SiH contact lenses
Risk of adverse events
Odds ratios (OR) for adverse events: contact lens-induced, mechanically-induced, inflammatory, and overall
Measured: Post-30-day CW of SiH contact lenses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start15 Jan 2012
- Primary completion15 Oct 2012
- Study completion15 Oct 2012
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 Corneal Epithelial PermeabilityStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 161 non-contact lens wearers were fit with silicone hydrogel (SiH) contact lenses and randomized to either a treatment (n = 81) or control (n = 80) group for 30-day continuous wear (CW). Subjects in the treatment group irrigated every morning and whenever dryness symptoms occurred; subjects in the control group did not.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meng C. Lin, University of California, Berkeley
- Investigators
- Meng C Lin, OD, PhD, FAAO, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139812
- Sponsor's protocol ID
- UCBCRCEW23
- Acronym
- EW23
- Status last verified
- May 2017
- First submitted
- 17 Apr 2017
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin MC, French HM, Graham AD, Sanders TL. Effects of daily irrigation on corneal epithelial permeability and adverse events with silicone hydrogel contact lens continuous wear. Invest Ophthalmol Vis Sci. 2014 Feb 10;55(2):776-83. doi: 10.1167/iovs.13-13508.
PubMed 24425854
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Daily Irrigation on Corneal Epithelial Permeability and Adverse Events With Silicone Hydrogel Contact Lens Continuous Wear
- ClinicalTrials.gov ID
- NCT03139812
- Acronym / sponsor ID
- EW23 / UCBCRCEW23
- Conditions
- Corneal Epithelial Permeability
- Keywords
- continuous contact lens wear, silicone hydrogel contact lenses, irrigation, corneal epithelial permeability, contact lens-related adverse events
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Study start
- 15 Jan 2012 (actual)
- Primary completion
- 15 Oct 2012 (actual)
- Study completion
- 15 Oct 2012 (actual)
- First posted
- 4 May 2017 (actual)
- 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.
This study sought to determine whether daily irrigation with sterile saline solution during silicone hydrogel (SiH) contact lens continuous wear (CW) could improve ocular surface integrity and reduce the risk of adverse events.
Detailed description
The purpose of this study was to determine whether daily irrigation with sterile saline solution during silicone hydrogel (SiH) contact lens 30-day continuous wear (CW) can mitigate increases in corneal epithelial permeability (Pdc) and reduce the risk of mechanical, contact lens-induced, inflammatory, and overall adverse events. 161 non-contact lens wearers were fit with SiH contact lenses and randomized to either a treatment (n = 81) or control (n = 80) group for 30-day CW. Subjects in the treatment group irrigated every morning and whenever dryness symptoms occurred; subjects in the control group did not.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 161 non-contact lens wearers were fit with silicone hydrogel (SiH) contact lenses and randomized to either a treatment (n = 81) or control (n = 80) group for 30-day continuous wear (CW). Subjects in the treatment group irrigated every morning and whenever dryness symptoms occurred; subjects in the control group did not.
| Arm | Type | Receives |
|---|---|---|
| 30-day SiH CW, No Daily Irrigation | Other | Device: 30-day SiH CWControl group subjects wore SiH lenses for 30-day CW under normal clinical practice guidelines with no daily morning irrigation of the eyes with sterile saline solution |
| 30-day SiH CW, Daily Irrigation | Other | Drug: Daily irrigation, Device: 30-day SiH CWTreatment group subjects wore SiH lenses for 30-day CW under normal clinical practice guidelines, and also irrigated the eyes with sterile saline solution every morning upon awakening |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- spectacle prescriptions between -1.00 diopter sphere (DS) and -10.00 DS;
- less than 0.75 diopters (D) of astigmatism;
- free of any ocular disease or systemic disease with ocular manifestation;
Key exclusion criteria (4 listed)
- history of contact lens wear within the past year;
- history of ocular surgery or serious injury;
- presence of corneal scarring;
- frequent swimming, smoking, or use of medications w/ ocular side effects;
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 |
|---|---|---|
| Daily irrigationAlso: Unisol 4 (Alcon Laboratories, Inc., Fort Worth, TX)Daily morning irrigation of the eye with sterile, borate-buffered, saline solution (Unisol 4) and gentle nudging of the lens to promote solution flow beneath the lens | Drug | 30-day SiH CW, Daily Irrigation |
| 30-day SiH CW30-day continuous wear of silicone hydrogel contact lenses | Device | 30-day SiH CW, Daily Irrigation, 30-day SiH CW, No Daily Irrigation |
Primary outcome
Corneal epithelial permeability (Pdc) at Baseline
Time frame: Baseline
Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec at baseline with no contact lenses
Corneal epithelial permeability (Pdc) Post-1-Day CW
Time frame: Post-1-Day CW of SiH contact lenses
Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec after 1 night of contact lens CW
Corneal epithelial permeability (Pdc) Post-30-Day CW
Time frame: Post-30-Day CW of SiH contact lenses
Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec after 30 nights of contact lens CW
Risk of adverse events
Time frame: Post-30-day CW of SiH contact lenses
Odds ratios (OR) for adverse events: contact lens-induced, mechanically-induced, inflammatory, and overall
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 4 May 2017.
- Background: PubMed 24425854Lin MC, French HM, Graham AD, Sanders TL. Effects of daily irrigation on corneal epithelial permeability and adverse events with silicone hydrogel contact lens continuous wear. Invest Ophthalmol Vis Sci. 2014 Feb 10;55(2):776-83. doi: 10.1167/iovs.13-13508.
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.
Meng C Lin, OD, PhD, FAAO principal investigator
University of California, Berkeley
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Daily irrigation and 30-day SiH CW in people with Corneal Epithelial Permeability, run by University of California, Berkeley.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. 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 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Corneal epithelial permeability (Pdc) at Baseline (time frame: Baseline). The study lists 4 primary outcomes in all. 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 NCT03139812, 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 4 May 2017.