Dry Eye DiseasePhase 3OPUS-3NCT02284516
A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)
A Phase 3 study testing Lifitegrast in people with Dry Eye Disease, run by Shire at 41 sites in United States.
Trial summary
Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Lifitegrast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 711 participants
- Where
- 41 sitesUnited States
- Study dates
- 6 Nov 2014to 5 Oct 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
- Patient-reported history of Dry Eye Disease in both eyes.
- Use of over the counter artificial tears within the past 30 days.
- A negative urine pregnancy test for females and willingness to use adequate birth control throughout the study.
- Able and willing to comply with all study procedures.
Who cannot join
- Presence of an ocular condition that could affect the study parameters such as active ocular infections, ocular inflammation, glaucoma, or diabetic retinopathy;.
- Unwilling to stop wearing contact lenses during the study.
- LASIK or other ocular surgical procedures within 12 months prior to or during the study.
- Use of prohibited medications
- Significant medical conditions that could affect the study parameters.
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
United States41 sites
Sall Research Medical Center
Artesia, California, 90701
University of Alabama at Birmingham, UAB School of Optometry
Birmingham, Alabama, 35294
Arizona Eye Center
Chandler, Arizona, 85225
Lifelong Vision Foundation
Chesterfield, Missouri, 63017
Abrams Eye Center
Cleveland, Ohio, 44115
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066
Matossian Eye Associates
Doylestown, Pennsylvania, 18902
The Cataract & Glaucoma Center
El Paso, Texas, 79902
Chicago Cornea Consultants, Ltd.
Hoffman Estates, Illinois, 60169
Advanced Laser Vision and Surgical Institute
Houston, Texas, 77034
Whitsett Vision Group
Houston, Texas, 77056
University of Houston College of Optometry
Houston, Texas, 77204
Price Vision Group
Indianapolis, Indiana, 46260
United Medical Research Institute
Inglewood, California, 90301
Tauber Eye Center
Kansas City, Missouri, 64111
Jackson Eye, SC
Lake Villa, Illinois, 60046
Wellish Vision Institute
Las Vegas, Nevada, 89119
Abrams Eye Institute
Las Vegas, Nevada, 89148
The Eye Clinic of Texas (Houston Eye Associates)
League City, Texas, 77573
Koffler Vision Group
Lexington, Kentucky, 40509
The Eye Care Institute
Louisville, Kentucky, 40206
See Clearly Vision
McLean, Virginia, 22012
North Valley Eye Medical Group, Inc
Mission Hills, California, 91345
Montebello Medical Eye Center, Inc.
Montebello, California, 90640
Toyos Clinic
Nashville, Tennessee, 37203
John-Kenyon American Eye Institute
New Albany, Indiana, 47150
Clinical Vision Research Center at SUNY
New York, New York, 10036
Eye Research Foundation
Newport Beach, California, 92663
Arch Health Partners
Poway, California, 92064
Martel Eye Medical Group
Rancho Cordova, California, 95670
Shasta Eye Medical Group, Inc.
Redding, California, 96001
Ophthalmic Consultants Of Long Island
Rockville Centre, New York, 11570
Eye Clinics of South Texas, P.A.
San Antonio, Texas, 78209
R and R Eye Research, LLC.
San Antonio, Texas, 78229
West Coast Eye Care Associates
San Diego, California, 92115
Tekwani Vision Center
St Louis, Missouri, 63128
Ophthalmology Consultants, Ltd.
St Louis, Missouri, 63131
Holpro Vision, Ltd.
Union, Kentucky, 41091
South Shore Eye Care, LLP
Wantagh, New York, 11793
Comprehensive Eye Care, Ltd.
Washington, Missouri, 63090
Clinical Eye Research of Boston
Winchester, Massachusetts, 01890
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-masked, and Placebo-controlled Study Evaluating the Efficacy and Safety of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease and History of Recent Artificial Tear Use
Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.
- Conditions
- Dry Eye Disease
- Being tested
- Lifitegrast, Placebo
- 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.
LifitegrastDrug
Lifitegrast Ophthalmic Solution 5%, BID for 84 days
PlaceboDrug
Placebo to match active treatment, BID for 84 days
| Study group | Role | What they receive |
|---|---|---|
| Lifitegrast | Experimental | Lifitegrast Ophthalmic Solution 5%, BID for 84 days Receives: Drug: Lifitegrast |
| Placebo | Placebo comparator | Placebo to match active treatment, BID for 84 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Patient-Reported Eye Dryness Score to Day 84
Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).
Measured: Baseline to Day 84
Secondary outcomes (1)
Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42
Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).
Measured: Baseline to Day 14 and Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study start6 Nov 2014
- Primary completion5 Oct 2015
- Study completion5 Oct 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 (2)Papers the sponsor has linked to this study.
- Other trials for Dry Eye DiseaseStudies 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
- 711 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284516
- Sponsor's protocol ID
- SHP606-304
- Acronym
- OPUS-3
- Status last verified
- Jun 2021
- First submitted
- 30 Oct 2014
- Last updated
- 11 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Holland EJ, Jackson MA, Donnenfeld E, Piccolo R, Cohen A, Barabino S, Rolando M, Figueiredo FC. Efficacy of Lifitegrast Ophthalmic Solution, 5.0%, in Patients With Moderate to Severe Dry Eye Disease: A Post Hoc Analysis of 2 Randomized Clinical Trials. JAMA Ophthalmol. 2021 Nov 1;139(11):1200-1208. doi: 10.1001/jamaophthalmol.2021.3943.
PubMed 34617974Holland EJ, Luchs J, Karpecki PM, Nichols KK, Jackson MA, Sall K, Tauber J, Roy M, Raychaudhuri A, Shojaei A. Lifitegrast for the Treatment of Dry Eye Disease: Results of a Phase III, Randomized, Double-Masked, Placebo-Controlled Trial (OPUS-3). Ophthalmology. 2017 Jan;124(1):53-60. doi: 10.1016/j.ophtha.2016.09.025. Epub 2016 Oct 27.
PubMed 28079022
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-masked, and Placebo-controlled Study Evaluating the Efficacy and Safety of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease and History of Recent Artificial Tear Use
- ClinicalTrials.gov ID
- NCT02284516
- Acronym / sponsor ID
- OPUS-3 / SHP606-304
- Conditions
- Dry Eye Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 711 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2014 (actual)
- Primary completion
- 5 Oct 2015 (actual)
- Study completion
- 5 Oct 2015 (actual)
- First posted
- 6 Nov 2014 (estimated)
- Results
- Posted 15 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifitegrast | Experimental | Drug: LifitegrastLifitegrast Ophthalmic Solution 5%, BID for 84 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo to match active treatment, BID for 84 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient-reported history of Dry Eye Disease in both eyes.
- Use of over the counter artificial tears within the past 30 days.
- A negative urine pregnancy test for females and willingness to use adequate birth control throughout the study.
- Able and willing to comply with all study procedures.
Key exclusion criteria (5 listed)
- Presence of an ocular condition that could affect the study parameters such as active ocular infections, ocular inflammation, glaucoma, or diabetic retinopathy;.
- Unwilling to stop wearing contact lenses during the study.
- LASIK or other ocular surgical procedures within 12 months prior to or during the study.
- Use of prohibited medications
- Significant medical conditions that could affect the study parameters.
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 |
|---|---|---|
| LifitegrastLifitegrast Ophthalmic Solution 5%, BID for 84 days | Drug | Lifitegrast |
| PlaceboPlacebo to match active treatment, BID for 84 days | Drug | Placebo |
Primary outcome
Change From Baseline in Patient-Reported Eye Dryness Score to Day 84
Time frame: Baseline to Day 84
Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).
1 secondary outcome
Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42
Time frame: Baseline to Day 14 and Day 42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34617974Holland EJ, Jackson MA, Donnenfeld E, Piccolo R, Cohen A, Barabino S, Rolando M, Figueiredo FC. Efficacy of Lifitegrast Ophthalmic Solution, 5.0%, in Patients With Moderate to Severe Dry Eye Disease: A Post Hoc Analysis of 2 Randomized Clinical Trials. JAMA Ophthalmol. 2021 Nov 1;139(11):1200-1208. doi: 10.1001/jamaophthalmol.2021.3943.
- Derived from this study: PubMed 28079022Holland EJ, Luchs J, Karpecki PM, Nichols KK, Jackson MA, Sall K, Tauber J, Roy M, Raychaudhuri A, Shojaei A. Lifitegrast for the Treatment of Dry Eye Disease: Results of a Phase III, Randomized, Double-Masked, Placebo-Controlled Trial (OPUS-3). Ophthalmology. 2017 Jan;124(1):53-60. doi: 10.1016/j.ophtha.2016.09.025. Epub 2016 Oct 27.
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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.
Study Director study director
Takeda
41 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 Lifitegrast in people with Dry Eye Disease, run by Shire at 41 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 4 inclusion and 5 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 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 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. Some participants in this study may receive a placebo. 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 15 Mar 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 Patient-Reported Eye Dryness Score to Day 84 (time frame: Baseline to Day 84). 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 NCT02284516, which also lists 2 linked publications.
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 11 Jun 2021.