Dry Eye SyndromesPhase 3NCT01459588
Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease
A Phase 3 study testing Carboxymethylcellulose Based Eye Drop Formulation A, Carboxymethylcellulose Based Eye Drop Formulation B and Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops in people with Dry Eye Syndromes, run by Allergan at 1 site in United States.
Trial summary
This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects 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 Formulation A, Carboxymethylcellulose Based Eye Drop Formulation B and Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2011to 15 Feb 2012
- 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
- Dry eyes
- Current use of eye drops for dry eye at least twice daily, on average for at least 3 months
Who cannot join
- Cataract, laser-assisted in situ keratomileusis (LASIK), or photorefractive keratectomy (PRK) surgery in the last 12 months
- Need to wear contact lenses during the study, or has worn contact lenses in the last 6 months
- Active ocular allergy
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects with dry eye disease.
- Conditions
- Dry Eye Syndromes
- Being tested
- Carboxymethylcellulose Based Eye Drop Formulation A, Carboxymethylcellulose Based Eye Drop Formulation B, Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops, Carboxymethylcellulose Based Lubricant Eye Drops
- 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 Drop Formulation ADrug
Also called Refresh Optive® Advanced Sensitive Eye Drops
Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
Carboxymethylcellulose Based Eye Drop Formulation BDrug
Also called Refresh Optive® Advanced Eye Drops
Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Carboxymethylcellulose Based Preservative-Free Lubricant Eye DropsDrug
Also called Optive® Sensitive Preservative-Free Lubricant Eye Drops
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Carboxymethylcellulose Based Lubricant Eye DropsDrug
Also called Optive® Lubricant Eye Drops
Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Carboxymethylcellulose Based Eye Drop Formulation A | Experimental | Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. Receives: Drug: Carboxymethylcellulose Based Eye Drop Formulation A |
| Carboxymethylcellulose Based Eye Drop Formulation B | Experimental | Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. Receives: Drug: Carboxymethylcellulose Based Eye Drop Formulation B |
| Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Active comparator | Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. Receives: Drug: Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops |
| Carboxymethylcellulose Based Lubricant Eye Drops | Active comparator | Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. Receives: Drug: Carboxymethylcellulose Based Lubricant Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Ocular Surface Disease Index© Questionnaire Score
The Ocular Surface Disease Index© Questionnaire is a 12-item survey assessing the overall severity of dry eye disease per patient. Each question is rated on a 5-point scale ranging from 0=none of the time to 4=all of the time for a total possible score of 0=No disease to 100=Maximum severity of disease. A negative change from baseline indicates improvement.
Measured: Baseline, Day 30
Secondary outcomes (4)
Change From Baseline in Tear Break-up Time
Tear Break-up Time (TBUT) was assessed at Baseline and Day 30. TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The shorter the tear break-up time, the worse the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive change from baseline indicates improvement.
Measured: Baseline, Day 30
Change From Baseline in Corneal Staining
The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0= no staining, 5 = severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in corneal staining (improvement).
Measured: Baseline, Day 30
Change From Baseline in Conjunctival Staining
The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement).
Measured: Baseline, Day 30
Change From Baseline in Schirmer Test Results
The Schirmer Test measures the rate of the secretion of tears produced by the 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. The worse eye at baseline is used to calculate the change at Day 30. A positive number change from baseline indicates an increase in tears (improvement).
Measured: Baseline, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study start1 Oct 2011
- Primary completion15 Feb 2012
- Study completion15 Feb 2012
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 315 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
- NCT01459588
- Sponsor's protocol ID
- 10146X-001
- Status last verified
- Apr 2019
- First submitted
- 24 Oct 2011
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Simmons PA, Carlisle-Wilcox C, Vehige JG. Comparison of novel lipid-based eye drops with aqueous eye drops for dry eye: a multicenter, randomized controlled trial. Clin Ophthalmol. 2015 Apr 15;9:657-64. doi: 10.2147/OPTH.S74849. eCollection 2015.
PubMed 25931806
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT01459588
- Acronym / sponsor ID
- 10146X-001
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2011 (actual)
- Primary completion
- 15 Feb 2012 (actual)
- Study completion
- 15 Feb 2012 (actual)
- First posted
- 25 Oct 2011 (estimated)
- Results
- Posted 14 Mar 2013
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, efficacy, and acceptability of an eye drop formulation in subjects with dry eye disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Carboxymethylcellulose Based Eye Drop Formulation A | Experimental | Drug: Carboxymethylcellulose Based Eye Drop Formulation ACarboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. |
| Carboxymethylcellulose Based Eye Drop Formulation B | Experimental | Drug: Carboxymethylcellulose Based Eye Drop Formulation BCarboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
| Carboxymethylcellulose Preservative-Free Lubricant Eye Drops | Active comparator | Drug: Carboxymethylcellulose Based Preservative-Free Lubricant Eye DropsCarboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
| Carboxymethylcellulose Based Lubricant Eye Drops | Active comparator | Drug: Carboxymethylcellulose Based Lubricant Eye DropsCarboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 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)
- Dry eyes
- Current use of eye drops for dry eye at least twice daily, on average for at least 3 months
Key exclusion criteria (3 listed)
- Cataract, laser-assisted in situ keratomileusis (LASIK), or photorefractive keratectomy (PRK) surgery in the last 12 months
- Need to wear contact lenses during the study, or has worn contact lenses in the last 6 months
- Active ocular allergy
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 Drop Formulation AAlso: Refresh Optive® Advanced Sensitive Eye DropsCarboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. | Drug | Carboxymethylcellulose Based Eye Drop Formulation A |
| Carboxymethylcellulose Based Eye Drop Formulation BAlso: Refresh Optive® Advanced Eye DropsCarboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. | Drug | Carboxymethylcellulose Based Eye Drop Formulation B |
| Carboxymethylcellulose Based Preservative-Free Lubricant Eye DropsAlso: Optive® Sensitive Preservative-Free Lubricant Eye DropsCarboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days. | Drug | Carboxymethylcellulose Preservative-Free Lubricant Eye Drops |
| Carboxymethylcellulose Based Lubricant Eye DropsAlso: Optive® Lubricant Eye DropsCarboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days. | Drug | Carboxymethylcellulose Based Lubricant Eye Drops |
Primary outcome
Change From Baseline in Ocular Surface Disease Index© Questionnaire Score
Time frame: Baseline, Day 30
The Ocular Surface Disease Index© Questionnaire is a 12-item survey assessing the overall severity of dry eye disease per patient. Each question is rated on a 5-point scale ranging from 0=none of the time to 4=all of the time for a total possible score of 0=No disease to 100=Maximum severity of disease. A negative change from baseline indicates improvement.
4 secondary outcomes
Change From Baseline in Tear Break-up Time
Time frame: Baseline, Day 30
Change From Baseline in Corneal Staining
Time frame: Baseline, Day 30
Change From Baseline in Conjunctival Staining
Time frame: Baseline, Day 30
Change From Baseline in Schirmer Test Results
Time frame: Baseline, Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25931806Simmons PA, Carlisle-Wilcox C, Vehige JG. Comparison of novel lipid-based eye drops with aqueous eye drops for dry eye: a multicenter, randomized controlled trial. Clin Ophthalmol. 2015 Apr 15;9:657-64. doi: 10.2147/OPTH.S74849. eCollection 2015.
Related trials for Dry Eye Syndromes
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Recruiting
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
Dry Eye Disease
Not yet recruiting
TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
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
1 site in 1 country: 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 Formulation A, Carboxymethylcellulose Based Eye Drop Formulation B and Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops in people with Dry Eye Syndromes, run by Allergan at 1 site in United States.
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 16 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 1 site in United States. 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 14 Mar 2013). 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 Ocular Surface Disease Index© Questionnaire Score (time frame: Baseline, Day 30). 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 NCT01459588, 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 16 Apr 2019.