Dry EyePhase 2NCT00607776
Artificial Tears Study in Mild to Moderate Dry Eye Patients
A Phase 2 study testing (9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400 and Systane in people with Dry Eye, run by Abbott Medical Optics.
Trial summary
The mean change in the subjective comfort score from baseline of the test group is at least 2.0 units less than that of the control group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- (9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400 and Systane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Apr 2007
- Phase
- Phase 2
- 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
- Mild to moderate dry eye
- over 18
Who cannot join
- No concurrent ocular disease or meds
About this study
The mean change in the subjective comfort score from baseline of the test group is at least 2.0 units less than that of the control group.
- Conditions
- Dry Eye
- Being tested
- (9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400, Systane
- Keywords
- dry, eyes, Amelioration of dry eye symptoms
- Medical subject headings
- Dry Eye Syndromes, Xerophthalmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400Drug
Drops
SystaneDrug
Drops
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Systane Receives: Drug: Systane |
| 2 | Experimental | Blink tears Receives: Drug: (9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective ocular comfort
Measured: 1 Month
Secondary outcomes (1)
Vision quality
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startJan 2007
- Study completionApr 2007
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Optics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eric Donnenfeld, M.D., Principal investigator, Ophthalmic Consultants of Long Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607776
- Sponsor's protocol ID
- PEGT-104-9582
- Status last verified
- Jan 2025
- First submitted
- 19 Dec 2007
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Tears Study in Mild to Moderate Dry Eye Patients
- ClinicalTrials.gov ID
- NCT00607776
- Acronym / sponsor ID
- PEGT-104-9582
- Conditions
- Dry Eye
- Keywords
- dry, eyes, Amelioration of dry eye symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Abbott Medical OpticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Study completion
- Apr 2007 (actual)
- First posted
- 6 Feb 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 mean change in the subjective comfort score from baseline of the test group is at least 2.0 units less than that of the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: SystaneSystane |
| 2 | Experimental | Drug: (9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400Blink tears |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mild to moderate dry eye
- over 18
Key exclusion criteria (1 listed)
- No concurrent ocular disease or meds
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 |
|---|---|---|
| (9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400Drops | Drug | 2 |
| SystaneDrops | Drug | 1 |
Primary outcome
Subjective ocular comfort
Time frame: 1 Month
1 secondary outcome
Vision quality
Time frame: 1 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 3 Feb 2025.
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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.
Eric Donnenfeld, M.D. principal investigator
Ophthalmic Consultants of Long Island
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing (9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400 and Systane in people with Dry Eye, run by Abbott Medical Optics.
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 2 inclusion and 1 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 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Subjective ocular comfort (time frame: 1 Month). 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 2025.