Contact Lens Solution ToxicityNCT01847105
Assessing Patient Comfort With Two Different Multi-Purpose Disinfecting Solutions
A study testing RevitaLens and OptiFree PureMoist in people with Contact Lens Solution Toxicity, run by Hom, Milton M., OD, FAAO at 3 sites in United States.
Trial summary
Tolerability is compared between two Multi-purpose disinfecting solutions (MPDS). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Contact Lens Solution Toxicity
- What is being tested?
- RevitaLens and OptiFree PureMoist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2013to May 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and over inclusive.
- Males or females
- Patient is in generally good \& stable overall health.
- Patient likely to comply with study guidelines \& study visits.
- Informed consent signed.
- Are willing/able to return for all required study visits.
- Are willing/able to follow instructions from the study investigator and his/her staff.
- Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee.
Who cannot join
- Corneal refractive surgery within 6 months of this study.
- Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
- Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Milton M. Hom, OD, FAAO
Azusa, California, 91702
Ian Ben Gaddie, OD, FAAO.
Louisville, Kentucky, 40222
Kirk L. Smick, OD, FAAO.
Morrow, Georgia, 30260
About this study
Official title: Assessing Patient Comfort in Silicone Hydrogel Contact Lenses When Cleaned and Stored in Two Different Multi-Purpose Disinfecting Solutions
Tolerability is compared between two Multi-purpose disinfecting solutions (MPDS).
Read the detailed description
According to recent surveys of contact lens fitters, the most prescribed treatments for contact lens dryness are: more frequent replacement schedule (24%), refit into different material (23%), rewetting drops (21%) and change care system (15%). Changing care systems has been a standard treatment for CL discomfort for many years. In the same survey, 30% of practitioners felt there is absolutely no difference among solutions with respect to reducing dryness and discomfort.
The investigators set out to compare the clinical performance of these two solutions: AMO's RevitaLens and Alcon's Opti-Free PureMoist.
- Conditions
- Contact Lens Solution Toxicity
- Being tested
- RevitaLens, OptiFree PureMoist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevitaLensOther
Also called AMO's RevitaLens
Multi-purpose disinfecting solution
OptiFree PureMoistOther
Also called Alcon's OptiFree PureMoist MPS
Multi-purpose disinfecting solution
| Study group | Role | What they receive |
|---|---|---|
| RevitaLens | Experimental | AMO's RevitaLens contact lens solution Receives: Other: RevitaLens; Other: OptiFree PureMoist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported comfort scores with contact lens care systems
Comfort measured by questionnaires covering positive and negative attributes of contact lens wear
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Lens Solution ToxicityStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hom, Milton M., OD, FAAO
- Collaborators
- Abbott Medical Optics
- Responsible party
- Principal investigator, Milton M. Hom, OD, FAAO., Hom, Milton M., OD, FAAO
- Investigators
- Milton M Hom, OD FAAO, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847105
- Sponsor's protocol ID
- 12-GHS Comfort Study
- Status last verified
- May 2013
- First submitted
- 24 Apr 2013
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Patient Comfort in Silicone Hydrogel Contact Lenses When Cleaned and Stored in Two Different Multi-Purpose Disinfecting Solutions
- ClinicalTrials.gov ID
- NCT01847105
- Acronym / sponsor ID
- 12-GHS Comfort Study
- Conditions
- Contact Lens Solution Toxicity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Hom, Milton M., OD, FAAO
- Collaborators
- Abbott Medical Optics
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 6 May 2013 (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.
Tolerability is compared between two Multi-purpose disinfecting solutions (MPDS).
Detailed description
According to recent surveys of contact lens fitters, the most prescribed treatments for contact lens dryness are: more frequent replacement schedule (24%), refit into different material (23%), rewetting drops (21%) and change care system (15%). Changing care systems has been a standard treatment for CL discomfort for many years. In the same survey, 30% of practitioners felt there is absolutely no difference among solutions with respect to reducing dryness and discomfort.
The investigators set out to compare the clinical performance of these two solutions: AMO's RevitaLens and Alcon's Opti-Free PureMoist.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RevitaLens | Experimental | Other: RevitaLens, Other: OptiFree PureMoistAMO's RevitaLens contact lens solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Between the ages of 18 and over inclusive.
- Males or females
- Patient is in generally good \& stable overall health.
- Patient likely to comply with study guidelines \& study visits.
- Informed consent signed.
Key exclusion criteria (3 listed)
- Corneal refractive surgery within 6 months of this study.
- Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
- Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
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 |
|---|---|---|
| RevitaLensAlso: AMO's RevitaLensMulti-purpose disinfecting solution | Other | RevitaLens |
| OptiFree PureMoistAlso: Alcon's OptiFree PureMoist MPSMulti-purpose disinfecting solution | Other | RevitaLens |
Primary outcome
Self-reported comfort scores with contact lens care systems
Time frame: 14 days
Comfort measured by questionnaires covering positive and negative attributes of contact lens wear
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
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.
Milton M Hom, OD FAAO principal investigator
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RevitaLens and OptiFree PureMoist in people with Contact Lens Solution Toxicity, run by Hom, Milton M., OD, FAAO at 3 sites 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?
The sponsor lists 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
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?
Self-reported comfort scores with contact lens care systems (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2013.