Dry Eye SyndromesPhase 3NCT02553772
A Safety and Efficacy Study of a New Eye Drop Formulation in Patients With Dry Eye Disease.
A Phase 3 study testing Carboxymethylcellulose Based Eye Drop and Carboxymethylcellulose Sodium 0.5% in people with Dry Eye Syndromes, run by Allergan at 13 sites in 2 countries.
Trial summary
This study will evaluate the safety and efficacy of a new eye drop formulation in patients with dry eye disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Carboxymethylcellulose Based Eye Drop and Carboxymethylcellulose Sodium 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 6 Jan 2016to 9 Sep 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Used artificial tears for dry eye
- Visual acuity of at least 20/32 (while wearing glasses, if necessary).
Who cannot join
- Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
- Herpes keratitis in the last 6 months
- Cataract surgery, laser-assisted in situ keratomileusis [LASIK], or photorefractive keratectomy, within the last 6 months
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States10 sites
Texan Eye
Austin, Texas, 78731
The Private Practice of Milton Hom, OD
Azusa, California, 91702
Havana Research Institute LLC
Burbank, California, 91506
Charlotte Eye Ear Nose
Charlotte, North Carolina, 28210
Scott and Christie and Associate
Cranberry Township, Pennsylvania, 16066
Lugene Eye Institute
Glendale, California, 91204
Moyes Eye Center, PC
Kansas City, Missouri, 64154
Rochester Ophthalmological Group, PC
Rochester, New York, 14618
Eric M. White, OD, INC
San Diego, California, 92123
Ophthalmology Associates
St Louis, Missouri, 63131
Australia3 sites
Department of Optometry & Vision Sciences, The University of Melbourne
Parkville, VIC 3010
Prof. M.T. Coroneo Pty. Ltd.
Randwick, NSW 2031
The University of New South Wales School of Optometry and Vision Science
Sydney, NSW 2052
About this study
Official title: A Multicenter, Double-masked, Randomized Study to Compare the Safety and Efficacy of the OM3 Tear Formulation With REFRESH OPTIVE® ADVANCED Unit Dose for 3 Months in Patients With Dry Eye Disease
This study will evaluate the safety and efficacy of a new eye drop formulation in patients with dry eye disease.
- Conditions
- Dry Eye Syndromes
- Being tested
- Carboxymethylcellulose Based Eye Drop, Carboxymethylcellulose Sodium 0.5%
- 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.
Carboxymethylcellulose Based Eye DropDrug
Carboxymethylcellulose based eye drop (OM3 Tear) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Carboxymethylcellulose Sodium 0.5%Drug
Also called REFRESH OPTIVE® ADVANCED
Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| OM3 Tear | Experimental | Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. Receives: Drug: Carboxymethylcellulose Based Eye Drop |
| REFRESH OPTIVE® ADVANCED | Active comparator | Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. Receives: Drug: Carboxymethylcellulose Sodium 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
The OSDI© consists of 12 questions the patient is asked measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale where 0=none of the time and 4=all of the time. The score is converted to a 0 to 100-point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement.
Measured: Baseline, Day 90
Secondary outcomes (4)
Change From Baseline in Tear Break-up Time (TBUT)
TBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. The worse eye is used for the calculations and is defined as the eye with the shortest average TBUT at Baseline. A positive number change from Baseline indicates improvement and a negative number change from Baseline indicates a worsening.
Measured: Baseline, Day 90
Change From Baseline in Corneal Staining Score
Total corneal staining with fluorescein was measured in the worse eye using a 6-point scale where 0= none, no staining (best) to 5=severe staining (worst). The total score is calculated as the sum of 5 regions of the cornea, resulting in a possible minimum score of 0 and a maximum possible score of 25 (severe staining score of 5 in all 5 regions). The worse eye is defined as the eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Measured: Baseline, Day 90
Change From Baseline in Conjunctival Staining Score
Total conjunctival staining with lissamine green was measured in the worse eye using a 6-point scale where 0= none (best), no staining to 5=severe staining (worst). The total score is calculated as the sum of the 6 regions of the conjunctiva, resulting in a minimum possible score of 0 maximum possible score of 30 (severe staining score of 5 in 6 regions). The worse eye is defined as eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Measured: Baseline, Day 90
Change From Baseline in the Schirmer Test
The Schirmer Test measures tears produced by the eye over 5 minutes using a paper strip inserted into the eye. The results indicate the presence of dry eye (Normal = greater than 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. The worse eye defined as the eye with the lowest score at baseline is used to calculate the change at Day 90. A positive number change from baseline indicates an increase in tears (improvement).
Measured: Baseline, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study start6 Jan 2016
- Primary completion9 Sep 2016
- Study completion9 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry Eye SyndromesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553772
- Sponsor's protocol ID
- 11182X-001
- Status last verified
- Oct 2017
- First submitted
- 16 Sep 2015
- Last updated
- 17 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-masked, Randomized Study to Compare the Safety and Efficacy of the OM3 Tear Formulation With REFRESH OPTIVE® ADVANCED Unit Dose for 3 Months in Patients With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT02553772
- Acronym / sponsor ID
- 11182X-001
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2016 (actual)
- Primary completion
- 9 Sep 2016 (actual)
- Study completion
- 9 Sep 2016 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Posted 17 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of a new eye drop formulation in patients with dry eye disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OM3 Tear | Experimental | Drug: Carboxymethylcellulose Based Eye DropCarboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. |
| REFRESH OPTIVE® ADVANCED | Active comparator | Drug: Carboxymethylcellulose Sodium 0.5%Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Used artificial tears for dry eye
- Visual acuity of at least 20/32 (while wearing glasses, if necessary).
Key exclusion criteria (3 listed)
- Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
- Herpes keratitis in the last 6 months
- Cataract surgery, laser-assisted in situ keratomileusis [LASIK], or photorefractive keratectomy, within the last 6 months
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 |
|---|---|---|
| Carboxymethylcellulose Based Eye DropCarboxymethylcellulose based eye drop (OM3 Tear) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. | Drug | OM3 Tear |
| Carboxymethylcellulose Sodium 0.5%Also: REFRESH OPTIVE® ADVANCEDCarboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. | Drug | REFRESH OPTIVE® ADVANCED |
Primary outcome
Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
Time frame: Baseline, Day 90
The OSDI© consists of 12 questions the patient is asked measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale where 0=none of the time and 4=all of the time. The score is converted to a 0 to 100-point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement.
4 secondary outcomes
Change From Baseline in Tear Break-up Time (TBUT)
Time frame: Baseline, Day 90
Change From Baseline in Corneal Staining Score
Time frame: Baseline, Day 90
Change From Baseline in Conjunctival Staining Score
Time frame: Baseline, Day 90
Change From Baseline in the Schirmer Test
Time frame: Baseline, Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director study director
Allergan
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Carboxymethylcellulose Based Eye Drop and Carboxymethylcellulose Sodium 0.5% in people with Dry Eye Syndromes, run by Allergan at 13 sites in 2 countries.
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 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: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Australia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score (time frame: Baseline, Day 90). 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 17 Nov 2017.