Dry Eye SyndromesPhase 4NCT02117687
A Safety and Efficacy Study of OPTIVE FUSION™ With VISMED® Multi for the Management of Dry Eye
A Phase 4 study testing carboxymethylcellulose 0.5%/glycerin 0.9% and sodium hyaluronate 0.18% in people with Dry Eye Syndromes and Keratoconjunctivitis Sicca, run by Allergan at 2 sites in 2 countries.
Trial summary
This study will evaluate the safety and efficacy of OPTIVE FUSION™ compared to VISMED® Multi for the management of dry eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
- What is being tested?
- carboxymethylcellulose 0.5%/glycerin 0.9% and sodium hyaluronate 0.18%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 May 2014to 17 Mar 2015
- Phase
- Phase 4
- 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
- Use of artificial tears for dry eye in both eyes for at least 3 months
- Use of preservative-free artificial tears at least twice daily for 2 weeks;
Who cannot join
- Cataract, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK) surgery in the last 12 months
- Use of punctal plugs or contact lenses in the last month
- Active ocular allergy within last 2 years
- Best corrected visual acuity (BCVA) less than 20/200 in either eye
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
This study will evaluate the safety and efficacy of OPTIVE FUSION™ compared to VISMED® Multi for the management of dry eye.
- Conditions
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
- Being tested
- carboxymethylcellulose 0.5%/glycerin 0.9%, sodium hyaluronate 0.18%
- Medical subject headings
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboxymethylcellulose 0.5%/glycerin 0.9%Drug
Also called OPTIVE FUSION™
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
sodium hyaluronate 0.18%Drug
Also called VISMED® Multi
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| OPTIVE FUSION™ | Active comparator | 1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months. Receives: Drug: carboxymethylcellulose 0.5%/glycerin 0.9% |
| VISMED® Multi | Active comparator | 1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months. Receives: Drug: sodium hyaluronate 0.18% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Global Ocular Staining Score in the Study Eye
Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal.
Measured: Baseline, Day 35
Secondary outcomes (13)
Change From Baseline in Global Ocular Staining Score in the Study Eye
Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal.
Measured: Baseline, Month 3
Change From Baseline in Ocular Surface Disease Index© (OSDI) Score
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms on a 5-point scale (0=none of the time and 4=all of the time). Higher scores represent greater disability. Scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement and a positive number change from baseline represents a worsening.
Measured: Baseline, Day 35
Change From Baseline in the Schirmer Test in the Study Eye
The Schirmer's Test measures the rate of secretion of tears produced by the study eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement) and a negative number change from baseline indicates a decrease in tears (worsening).
Measured: Baseline, Day 35
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Subjects assess dry eye symptoms on a 5-point scale (none, mild, moderate, severe, very severe).
Measured: Baseline, Day 35, Month 3
Subject Global Assessment of Treatment Efficacy on a 5-Point Scale
Subjects assess global treatment efficacy compared to baseline on a 5-point scale (much worse, worse, about the same, improved, much improved).
Measured: Baseline, Day 35, Month 3
Subject Assessment of Treatment Acceptability on a 5-Point Scale
Subjects assess treatment acceptability (likability and comfort) on a 5-point scale (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree).
Measured: Day 35
Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale
Investigators assess global treatment efficacy on a 4-point scale (very satisfactory, satisfactory, poor, very poor).
Measured: Day 35, Month 3
Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye
TBUT is the time required for dry spots to appear on the surface of the eye after blinking in the worse eye. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement) and a negative number change from baseline indicates a decrease in TBUT (worsening).
Measured: Baseline, Day 35
Work Productivity and Activity Impairment Questionnaire Score
The Work Productivity and Activity questionnaire assesses the effect of dry eye on the ability of subjects to work and perform regular activities on a scale from 0 to 10 during the past 7 days (0=dry eye had no effect on my work/daily activities to 10=dry eye completely prevented me from working/doing my daily activities). Since not all subjects were in full time employment during the study, not all items of the questionnaire were applicable to all subjects at each visit. Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Measured: Baseline, Day 35, Month 3
Change From Baseline in Corneal Staining in the Study Eye
The cornea is the transparent front part of the eye which covers the iris and pupil. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). A negative number change from baseline represents a decrease in corneal staining (improvement) and a positive number change from baseline represents an increase in corneal staining (worsening).
Measured: Baseline, Day 35, Month 3
Change From Baseline in Conjunctival Staining in the Study Eye
The conjunctiva is the clear membrane covering the white surface of the eye. Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining) in the temporal and nasal locations. A negative number change from baseline represents a decrease in corneal staining (improvement) and a positive number change from baseline represents an increase in corneal staining (worsening).
Measured: Baseline, Day 35, Month 3
Conjunctival Hyperaemia in the Study Eye
Macroscopic conjunctival hyperemia (eye redness) is graded in the study eye on a 5-point scale (none, trace, mild, moderate, severe).
Measured: Baseline, Day 35, Month 3
Study Product Use
The number of times the study product is administered per day is recorded.
Measured: Day 8, Day 35, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study start14 May 2014
- Primary completion27 Jan 2015
- Study completion17 Mar 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 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
- NCT02117687
- Sponsor's protocol ID
- MAF-AGN-OPH-DE-016
- Status last verified
- Apr 2019
- First submitted
- 16 Apr 2014
- Last updated
- 18 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Labetoulle M, Chiambaretta F, Shirlaw A, Leaback R, Baudouin C. Osmoprotectants, carboxymethylcellulose and hyaluronic acid multi-ingredient eye drop: a randomised controlled trial in moderate to severe dry eye. Eye (Lond). 2017 Oct;31(10):1409-1416. doi: 10.1038/eye.2017.73. Epub 2017 Apr 28.
PubMed 28452989
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study of OPTIVE FUSION™ With VISMED® Multi for the Management of Dry Eye
- ClinicalTrials.gov ID
- NCT02117687
- Acronym / sponsor ID
- MAF-AGN-OPH-DE-016
- Conditions
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 14 May 2014 (actual)
- Primary completion
- 27 Jan 2015 (actual)
- Study completion
- 17 Mar 2015 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Posted 19 Feb 2016
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 OPTIVE FUSION™ compared to VISMED® Multi for the management of dry eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPTIVE FUSION™ | Active comparator | Drug: carboxymethylcellulose 0.5%/glycerin 0.9%1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months. |
| VISMED® Multi | Active comparator | Drug: sodium hyaluronate 0.18%1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Use of artificial tears for dry eye in both eyes for at least 3 months
- Use of preservative-free artificial tears at least twice daily for 2 weeks;
Key exclusion criteria (4 listed)
- Cataract, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK) surgery in the last 12 months
- Use of punctal plugs or contact lenses in the last month
- Active ocular allergy within last 2 years
- Best corrected visual acuity (BCVA) less than 20/200 in either eye
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 0.5%/glycerin 0.9%Also: OPTIVE FUSION™1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months. | Drug | OPTIVE FUSION™ |
| sodium hyaluronate 0.18%Also: VISMED® Multi1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months. | Drug | VISMED® Multi |
Primary outcome
Change From Baseline in Global Ocular Staining Score in the Study Eye
Time frame: Baseline, Day 35
Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal.
13 secondary outcomes
Change From Baseline in Global Ocular Staining Score in the Study Eye
Time frame: Baseline, Month 3
Change From Baseline in Ocular Surface Disease Index© (OSDI) Score
Time frame: Baseline, Day 35
Change From Baseline in the Schirmer Test in the Study Eye
Time frame: Baseline, Day 35
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Time frame: Baseline, Day 35, Month 3
Subject Global Assessment of Treatment Efficacy on a 5-Point Scale
Time frame: Baseline, Day 35, Month 3
Subject Assessment of Treatment Acceptability on a 5-Point Scale
Time frame: Day 35
Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale
Time frame: Day 35, Month 3
Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye
Time frame: Baseline, Day 35
Work Productivity and Activity Impairment Questionnaire Score
Time frame: Baseline, Day 35, Month 3
Change From Baseline in Corneal Staining in the Study Eye
Time frame: Baseline, Day 35, Month 3
Change From Baseline in Conjunctival Staining in the Study Eye
Time frame: Baseline, Day 35, Month 3
Conjunctival Hyperaemia in the Study Eye
Time frame: Baseline, Day 35, Month 3
Study Product Use
Time frame: Day 8, Day 35, Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28452989Labetoulle M, Chiambaretta F, Shirlaw A, Leaback R, Baudouin C. Osmoprotectants, carboxymethylcellulose and hyaluronic acid multi-ingredient eye drop: a randomised controlled trial in moderate to severe dry eye. Eye (Lond). 2017 Oct;31(10):1409-1416. doi: 10.1038/eye.2017.73. Epub 2017 Apr 28.
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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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing carboxymethylcellulose 0.5%/glycerin 0.9% and sodium hyaluronate 0.18% in people with Dry Eye Syndromes and Keratoconjunctivitis Sicca, run by Allergan at 2 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 4 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 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, United Kingdom. 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 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?
Yes. Results are posted in the registry (first posted 19 Feb 2016). 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 Global Ocular Staining Score in the Study Eye (time frame: Baseline, Day 35). 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 NCT02117687, 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 Apr 2019.