Dry EyeNCT01294956
A Clinical Evaluation of an Investigational Lubricant Eye Gel (FID 115958D)
A study testing Lubricant Eye Drop and Refresh Liquigel in people with Dry Eye, run by Alcon Research.
Trial summary
The purpose of this study is to estimate the change in sodium fluorescein staining, as a sign of dry eye, during six weeks of treatment with FID 115958D or Refresh Liquigel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Lubricant Eye Drop and Refresh Liquigel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Apr 2011
- 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
- Documented diagnosis of dry eye
- NaFl Corneal staining sum score ≥ 3 in either eye
- Current use of a lubricant eye gel or ointment at least once per week (over the previous month)
Who cannot join
- No contact lenses wear throughout the study period
- Must not have had punctal plugs inserted within 30 days preceding enrollment
About this study
The purpose of this study is to estimate the change in sodium fluorescein staining, as a sign of dry eye, during six weeks of treatment with FID 115958D or Refresh Liquigel.
- Conditions
- Dry Eye
- Being tested
- Lubricant Eye Drop, Refresh Liquigel
- Keywords
- Dry eye, artificial tears, corneal staining
- 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.
Lubricant Eye DropOther
1 drop in each eye, four times a day for 42 days
Refresh LiquigelOther
1 drop in each eye, four times a day for 42 days
| Study group | Role | What they receive |
|---|---|---|
| FID 115958D | Experimental | Lubricant Eye Drop Receives: Other: Lubricant Eye Drop |
| Refresh Liquigel | Active comparator | Lubricant Eye Drop Receives: Other: Refresh Liquigel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Staining
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2011
- Study completionApr 2011
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 147 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
- NCT01294956
- Sponsor's protocol ID
- C-10-043
- Status last verified
- Jan 2012
- First submitted
- 10 Feb 2011
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Cohen S, Martin A, Sall K. Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose. Clin Ophthalmol. 2014;8:157-64. doi: 10.2147/OPTH.S53822. Epub 2013 Dec 31.
PubMed 24403819
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of an Investigational Lubricant Eye Gel (FID 115958D)
- ClinicalTrials.gov ID
- NCT01294956
- Acronym / sponsor ID
- C-10-043
- Conditions
- Dry Eye
- Keywords
- Dry eye, artificial tears, corneal staining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 14 Feb 2011 (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 is to estimate the change in sodium fluorescein staining, as a sign of dry eye, during six weeks of treatment with FID 115958D or Refresh Liquigel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FID 115958D | Experimental | Other: Lubricant Eye DropLubricant Eye Drop |
| Refresh Liquigel | Active comparator | Other: Refresh LiquigelLubricant Eye Drop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented diagnosis of dry eye
- NaFl Corneal staining sum score ≥ 3 in either eye
- Current use of a lubricant eye gel or ointment at least once per week (over the previous month)
Key exclusion criteria (2 listed)
- No contact lenses wear throughout the study period
- Must not have had punctal plugs inserted within 30 days preceding enrollment
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 |
|---|---|---|
| Lubricant Eye Drop1 drop in each eye, four times a day for 42 days | Other | FID 115958D |
| Refresh Liquigel1 drop in each eye, four times a day for 42 days | Other | Refresh Liquigel |
Primary outcome
Corneal Staining
Time frame: Day 42
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 18 Nov 2016.
- Results publication: PubMed 24403819Cohen S, Martin A, Sall K. Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose. Clin Ophthalmol. 2014;8:157-64. doi: 10.2147/OPTH.S53822. Epub 2013 Dec 31.
Related trials for Dry Eye
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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 study testing Lubricant Eye Drop and Refresh Liquigel 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 3 inclusion and 2 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 18 Nov 2016. 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.
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 Staining (time frame: Day 42). 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 NCT01294956, 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 18 Nov 2016.