Dry EyePhase 4NCT00809198
Kynex Versus Refresh Plus Study in Subject With Dry Eye
A Phase 4 study testing Sodium Hyaluronate and Carboxymethylcellulose sodium in people with Dry Eye, run by Alcon Research.
Trial summary
The effect of Kynex versus Refresh Plus in subjects with mild to moderate dry eye. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Sodium Hyaluronate and Carboxymethylcellulose sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to May 2009
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 years of age or older, of any race and either sex.
- Able to understand and sign an informed consent that has been approved by an Institutional Review Board.
- Criteria for the diagnosis must include the following two characteristics at Visit 1 (Day 1):
- Subjects' assessment of dry eye status (answer of at least "Some of the time" to the question, "How often have your eyes felt dry enough to want to use eye drops?"
- Sodium fluorescein (NaFl) corneal staining score sum of ≥3 in either eye (NEI scoring system).
- Able and willing to follow study instructions.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from this study:
- History or evidence of ocular or intraocular surgery in either eye within the past three months.
- History of intolerance or hypersensitivity to any component of the study medications.
- History or evidence of epithelial herpes simplex keratitis (dendrictic keratitis); vaccine, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
- Use of topical ocular medications during the study period.
- Subjects using systemic medications that may contribute to dry eye (e.g. cold and allergy medications, tricyclic antidepressants, hormone replacement therapies) may not be enrolled in the study unless they have been on a stable dosing regimen for a minimum of 30 days prior to Visit 1. In addition, the dosing regimen must remain stable throughout the study.
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- Presence of ocular conditions such as active acute blepharitis, conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of the test article.
- Subjects unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued at least one week prior to Visit 1.
- Current punctal occlusion of any type (e.g. collagen plugs, silicone plugs).
- Enrollment of the investigator or his or her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.
- Participation in any investigational drug or device study within 30 days of entering this study.
About this study
Official title: The Effect of Kynex Versus Refresh Plus in Subjects With Mild to Moderate Dry Eye - A Parallel Group, Randomized, Masked Study
The effect of Kynex versus Refresh Plus in subjects with mild to moderate dry eye.
- Conditions
- Dry Eye
- Being tested
- Sodium Hyaluronate, Carboxymethylcellulose sodium
- Keywords
- Sodium Hyaluronate, Kynex, Carboxymethylcellulose sodium, Refresh Plus, Dry Eye, Cornea Staining, TBUT
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium HyaluronateOther
Also called Kynex
Carboxymethylcellulose sodiumOther
Also called Refresh Plus
| Study group | Role | What they receive |
|---|---|---|
| Sodium Hyaluronate | Experimental | Sodium Hyaluronate (Kynex) Receives: Other: Sodium Hyaluronate |
| Carboxymethylcellulose sodium | Active comparator | Carboxymethylcellulose sodium (Refresh Plus) Receives: Other: Carboxymethylcellulose sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cornea Staining Score
Measured: 8 weeks
Secondary outcomes (1)
Dry Eye and symptoms
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 67 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
- NCT00809198
- Sponsor's protocol ID
- RM-08-06
- Status last verified
- Feb 2012
- First submitted
- 16 Dec 2008
- Last updated
- 3 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kynex Versus Refresh Plus in Subjects With Mild to Moderate Dry Eye - A Parallel Group, Randomized, Masked Study
- ClinicalTrials.gov ID
- NCT00809198
- Acronym / sponsor ID
- RM-08-06
- Conditions
- Dry Eye
- Keywords
- Sodium Hyaluronate, Kynex, Carboxymethylcellulose sodium, Refresh Plus, Dry Eye, Cornea Staining, TBUT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 17 Dec 2008 (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 effect of Kynex versus Refresh Plus in subjects with mild to moderate dry eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Hyaluronate | Experimental | Other: Sodium HyaluronateSodium Hyaluronate (Kynex) |
| Carboxymethylcellulose sodium | Active comparator | Other: Carboxymethylcellulose sodiumCarboxymethylcellulose sodium (Refresh Plus) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 20 years of age or older, of any race and either sex.
- Able to understand and sign an informed consent that has been approved by an Institutional Review Board.
- Criteria for the diagnosis must include the following two characteristics at Visit 1 (Day 1):
- Subjects' assessment of dry eye status (answer of at least "Some of the time" to the question, "How often have your eyes felt dry enough to want to use eye drops?"
- Sodium fluorescein (NaFl) corneal staining score sum of ≥3 in either eye (NEI scoring system).
Key exclusion criteria (11 listed)
- Subjects who meet any of the following criteria will be excluded from this study:
- History or evidence of ocular or intraocular surgery in either eye within the past three months.
- History of intolerance or hypersensitivity to any component of the study medications.
- History or evidence of epithelial herpes simplex keratitis (dendrictic keratitis); vaccine, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
- Use of topical ocular medications during the study period.
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 |
|---|---|---|
| Sodium HyaluronateAlso: Kynex | Other | Sodium Hyaluronate |
| Carboxymethylcellulose sodiumAlso: Refresh Plus | Other | Carboxymethylcellulose sodium |
Primary outcome
Cornea Staining Score
Time frame: 8 weeks
1 secondary outcome
Dry Eye and symptoms
Time frame: 8 weeks
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 3 Feb 2012.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium Hyaluronate and Carboxymethylcellulose sodium in people with Dry Eye, run by Alcon Research.
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 6 inclusion and 11 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 3 Feb 2012. 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?
Cornea Staining Score (time frame: 8 weeks). 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 3 Feb 2012.