Contact Lens Related Dry EyeNCT00995189
Clinical Evaluation of the Causes of Contact Lens Related Dry Eye
A study testing Opti-Free RepleniSH, ReNu MultiPlus and Contact lenses in people with Contact Lens Related Dry Eye, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study was to clinically evaluate the potential causes of contact lens-related dry eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Related Dry Eye
- What is being tested?
- Opti-Free RepleniSH, ReNu MultiPlus and Contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Apr 2010
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reports late-day dryness symptoms with contact lens wear on questionnaire.
- Wears FDA Group 2 hydrogel, FDA Group 4 hydrogel, or silicone hydrogel lenses.
- Consistently uses either polyhexamethylene biguanide (PHMB) or polyquaternium-1 (PQT) contact lens care products (i.e. >6 months including 1 month immediately before enrollment).
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Wears daily disposable contact lenses.
- Has significant symptoms related to lens fit or lens deposits.
- Requires concurrent ocular medication (rewetting drops allowed).
- Has used Restasis® in the last 3 months.
- Wears punctal plugs fitted in the last 30 days.
- Has any current systemic or ocular abnormality, infection or disease.
Show all 9Show fewer
- Uses any current systemic medication likely to affect tear film, e.g. antihistamines, betaadrenergic blockers, steroids.
- Has a history of refractive surgery.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, 76134
About this study
Official title: A Clinical Evaluation of the Causes of Soft Contact Lens Related Dry Eye
The purpose of this study was to clinically evaluate the potential causes of contact lens-related dry eye.
Read the detailed description
Daily wear soft contact lens wearers reporting significant contact lens-related dryness symptoms were enrolled. Late day dryness with contact lenses, intensity grade 3-5, frequency "sometimes / frequently / constantly" as evaluated by a questionnaire was considered significant.
- Conditions
- Contact Lens Related Dry Eye
- Being tested
- Opti-Free RepleniSH, ReNu MultiPlus, Contact lenses
- Keywords
- contact lens wear, multi-purpose solution, corneal staining
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opti-Free RepleniSHDevice
Contact lens care solution containing polyquaternium-1 (PQT)
ReNu MultiPlusDevice
Contact lens care solution containing polyhexamethylene biguanide (PHMB)
Contact lensesDevice
Daily wear, frequent replacement contact lenses per participant's habitual brand and power.
| Study group | Role | What they receive |
|---|---|---|
| OFR | Experimental | Opti-Free RepleniSH contact lens care solution used for 30 days Receives: Device: Opti-Free RepleniSH; Device: Contact lenses |
| RNM | Active comparator | ReNu MultiPlus contact lens care solution used for 30 days Receives: Device: ReNu MultiPlus; Device: Contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Dryness
Measured: 2 weeks, one month
Secondary outcomes (2)
corneal staining
Measured: 2 weeks, one month
conjunctival staining
Measured: two weeks, one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionApr 2010
- Study completionApr 2010
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 Lens Related Dry EyeStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe 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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995189
- Sponsor's protocol ID
- M-09-03 / DRYS 1302 / IBIS
- Status last verified
- Mar 2012
- First submitted
- 14 Oct 2009
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Chalmers RL, Young G, Kern J, Napier L, Hunt C. Soft Contact Lens-Related Symptoms in North America and the United Kingdom. Optom Vis Sci. 2016 Aug;93(8):836-47. doi: 10.1097/OPX.0000000000000927.
PubMed 27391535
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the Causes of Soft Contact Lens Related Dry Eye
- ClinicalTrials.gov ID
- NCT00995189
- Acronym / sponsor ID
- M-09-03 / DRYS 1302 / IBIS
- Conditions
- Contact Lens Related Dry Eye
- Keywords
- contact lens wear, multi-purpose solution, corneal staining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 15 Oct 2009 (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 study was to clinically evaluate the potential causes of contact lens-related dry eye.
Detailed description
Daily wear soft contact lens wearers reporting significant contact lens-related dryness symptoms were enrolled. Late day dryness with contact lenses, intensity grade 3-5, frequency "sometimes / frequently / constantly" as evaluated by a questionnaire was considered significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OFR | Experimental | Device: Opti-Free RepleniSH, Device: Contact lensesOpti-Free RepleniSH contact lens care solution used for 30 days |
| RNM | Active comparator | Device: ReNu MultiPlus, Device: Contact lensesReNu MultiPlus contact lens care solution used for 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Reports late-day dryness symptoms with contact lens wear on questionnaire.
- Wears FDA Group 2 hydrogel, FDA Group 4 hydrogel, or silicone hydrogel lenses.
- Consistently uses either polyhexamethylene biguanide (PHMB) or polyquaternium-1 (PQT) contact lens care products (i.e. >6 months including 1 month immediately before enrollment).
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (9 listed)
- Wears daily disposable contact lenses.
- Has significant symptoms related to lens fit or lens deposits.
- Requires concurrent ocular medication (rewetting drops allowed).
- Has used Restasis® in the last 3 months.
- Wears punctal plugs fitted in the last 30 days.
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 |
|---|---|---|
| Opti-Free RepleniSHContact lens care solution containing polyquaternium-1 (PQT) | Device | OFR |
| ReNu MultiPlusContact lens care solution containing polyhexamethylene biguanide (PHMB) | Device | RNM |
| Contact lensesDaily wear, frequent replacement contact lenses per participant's habitual brand and power. | Device | OFR, RNM |
Primary outcome
Subjective Dryness
Time frame: 2 weeks, one month
2 secondary outcomes
corneal staining
Time frame: 2 weeks, one month
conjunctival staining
Time frame: two weeks, one month
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 17 Nov 2016.
- Results publication: PubMed 27391535Chalmers RL, Young G, Kern J, Napier L, Hunt C. Soft Contact Lens-Related Symptoms in North America and the United Kingdom. Optom Vis Sci. 2016 Aug;93(8):836-47. doi: 10.1097/OPX.0000000000000927.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opti-Free RepleniSH, ReNu MultiPlus and Contact lenses in people with Contact Lens Related Dry Eye, run by Alcon Research 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?
The sponsor lists 4 inclusion and 9 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 17 Nov 2016. 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?
Subjective Dryness (time frame: 2 weeks, one month). 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 NCT00995189, 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 17 Nov 2016.