Dry Eye SyndromesPhase 3NCT02280473
A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease
A Phase 3 study testing Refresh Optive® Gel Drops and REFRESH LIQUIGEL® in people with Dry Eye Syndromes, run by Allergan at 10 sites in United States.
Trial summary
This study will evaluate the safety and efficacy o fRefresh Optive® Gel Drops 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?
- Refresh Optive® Gel Drops and REFRESH LIQUIGEL®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 10 sitesUnited States
- Study dates
- 13 Nov 2014to 16 Mar 2015
- 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
- Current use of an artificial tear product
- 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
- Cataract surgery, laser-assisted in situ keratomileusis [LASIK], or photorefractive keratectomy, within the last 6 months
- Current eye infection or inflammation
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Eye Center Northeast
Bangor, Maine, 04401
Primary Eyecare Group, PC
Brentwood, Tennessee, 37027
Moyes Eye Center, PC
Kansas City, Missouri, 64154
The Eye Center at Southern College of Optometry
Memphis, Tennessee, 38104
North Bay Eye Associates
Petaluma, California, 94954
Rochester Ophthalmological Group, PC
Rochester, New York, 14618
Eric M. White, OD, Inc.
San Diego, California, 92123
Ophthalmology Associates
St Louis, Missouri, 63131
David W. Ferris & Associates, Inc.
Warwick, Rhode Island, 02888
Comprehensive Eye Care, Ltd.
Washington, Missouri, 63090
About this study
This study will evaluate the safety and efficacy o fRefresh Optive® Gel Drops in patients with dry eye disease.
- Conditions
- Dry Eye Syndromes
- Being tested
- Refresh Optive® Gel Drops, REFRESH LIQUIGEL®
- 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.
Refresh Optive® Gel DropsDrug
Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
REFRESH LIQUIGEL®Drug
REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Refresh Optive® Gel Drops | Experimental | Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days. Receives: Drug: Refresh Optive® Gel Drops |
| REFRESH LIQUIGEL® | Active comparator | REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days. Receives: Drug: REFRESH LIQUIGEL® |
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 is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The 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.
Measured: Baseline, Day 30
Secondary outcomes (4)
Change From Baseline in the OSDI© Score
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The 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.
Measured: Baseline, Day 7
Change From Baseline in Tear Break-up Time (TBUT)
TBUT is 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. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement). The eye with shorter average TBUT at baseline is reported for each patient.
Measured: Baseline, Day 30
Change From Baseline in the Combined Corneal and Conjunctival Staining Scores
The cornea is the transparent front part of the eye which covers the iris and pupil. The conjunctiva is the clear membrane covering the white surface of the eye. The cornea is divided into 5 zones and the nasal and temporal conjunctiva is divided into 6 zones. The combined staining score is based on the sum of the five zones on the cornea and the six zones on the conjunctiva. Each zone is graded on a 0-5 scale (0=None; 1=trace; 2=mild; 3=moderate; 4=severe; 5=very severe), for a total score ranging from 0-55. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of staining (improvement). The eye with higher score at baseline is reported for each subject.
Measured: Baseline, Day 30
Change From Baseline in the Schirmer Test
The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears.. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates improvement. The eye with the lower value at baseline is used for each subject.
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 posted31 Oct 2014 (estimated)
- Study start13 Nov 2014
- Primary completion16 Mar 2015
- Study completion16 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 188 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
- NCT02280473
- Sponsor's protocol ID
- 11193X-001
- Status last verified
- Apr 2019
- First submitted
- 29 Oct 2014
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lievens C, Berdy G, Douglass D, Montaquila S, Lin H, Simmons P, Carlisle-Wilcox C, Vehige J, Haque S. Evaluation of an enhanced viscosity artificial tear for moderate to severe dry eye disease: A multicenter, double-masked, randomized 30-day study. Cont Lens Anterior Eye. 2019 Aug;42(4):443-449. doi: 10.1016/j.clae.2018.12.003. Epub 2018 Dec 17.
PubMed 30573298
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
- A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT02280473
- Acronym / sponsor ID
- 11193X-001
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2014 (actual)
- Primary completion
- 16 Mar 2015 (actual)
- Study completion
- 16 Mar 2015 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Posted 7 Jun 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 o fRefresh Optive® Gel Drops 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 |
|---|---|---|
| Refresh Optive® Gel Drops | Experimental | Drug: Refresh Optive® Gel DropsRefresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
| REFRESH LIQUIGEL® | Active comparator | Drug: REFRESH LIQUIGEL®REFRESH LIQUIGEL®; 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)
- Current use of an artificial tear product
- 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
- Cataract surgery, laser-assisted in situ keratomileusis [LASIK], or photorefractive keratectomy, within the last 6 months
- Current eye infection or inflammation
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 |
|---|---|---|
| Refresh Optive® Gel DropsRefresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days. | Drug | Refresh Optive® Gel Drops |
| REFRESH LIQUIGEL®REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days. | Drug | REFRESH LIQUIGEL® |
Primary outcome
Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
Time frame: Baseline, Day 30
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The 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.
4 secondary outcomes
Change From Baseline in the OSDI© Score
Time frame: Baseline, Day 7
Change From Baseline in Tear Break-up Time (TBUT)
Time frame: Baseline, Day 30
Change From Baseline in the Combined Corneal and Conjunctival Staining Scores
Time frame: Baseline, Day 30
Change From Baseline in the Schirmer Test
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 30573298Lievens C, Berdy G, Douglass D, Montaquila S, Lin H, Simmons P, Carlisle-Wilcox C, Vehige J, Haque S. Evaluation of an enhanced viscosity artificial tear for moderate to severe dry eye disease: A multicenter, double-masked, randomized 30-day study. Cont Lens Anterior Eye. 2019 Aug;42(4):443-449. doi: 10.1016/j.clae.2018.12.003. Epub 2018 Dec 17.
- Individual participant dataSharing planned: No
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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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Refresh Optive® Gel Drops and REFRESH LIQUIGEL® in people with Dry Eye Syndromes, run by Allergan at 10 sites 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 10 sites 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 7 Jun 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 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 NCT02280473, 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.