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Trial record 23 of 152 for:    Brimonidine

Study of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED)

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ClinicalTrials.gov Identifier: NCT03785340
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Ocugen

Brief Summary:
This study evaluates the use of Brimonidine tartrate nanoemulsion eye drop solution in the treatment of Dry Eye Disease (DED). Half of participants will receive Brimonidine and half will receive ophthalmic buffered saline (placebo).

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Brimonidine Tartrate Drug: Placebos Phase 3

Detailed Description:

Dry eye disease (DED) is a common ocular disorder involving the aberrant production and instability of tear film, which results in damage to the ocular surface and is correlated with symptoms of ocular discomfort.

This study will be a randomized, placebo-controlled, double-masked, multicenter phase 3 study in the United States conducted at approximately 25 centers. Upon meeting the eligibility criteria, enrolled subjects will be randomly assigned in a 1:1 (test:control) fashion to receive either Brimonidine Nanoemulsion Eye Drops 0.20% investigational product (test) or ophthalmic buffered saline (placebo).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Placebo-Controlled, Double-Masked, Multicenter, Safety and Efficacy Study of Brimonidine Tartrate 0.2% Nanoemulsion Eye Drops in Patients With Dry Eye Disease (DED)
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: OCU-310
Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks
Drug: Brimonidine Tartrate
Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks.
Other Name: OCU-310

Placebo Comparator: Placebos
Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks
Drug: Placebos
Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks.
Other Name: Ophthalmic buffered saline solution




Primary Outcome Measures :
  1. Symptom Assessment iN Dry Eye (SANDE) Questionnaire [ Time Frame: Change from baseline to 4 weeks (Day 28) ]
    Change in Symptom Assessment scores

  2. Lissamine Green Conjunctival Staining Score [ Time Frame: Change from baseline to 4 weeks (Day 28) ]
    Change from baseline


Secondary Outcome Measures :
  1. Symptom Assessment iN Dry Eye (SANDE) [ Time Frame: Change from baseline to 2 weeks (Day 14) ]
    Change in Symptom Assessment scores

  2. Lissamine Green Conjunctival Staining [ Time Frame: Change from baseline to 2 weeks (Day 14) ]
    Change from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 18 years or older.
  2. Sign and date informed consent form approved by the IRB
  3. History of Dry Eye Disease for ≥6 months
  4. Demonstrate the following 2 signs of DED in the same eye at Screening and Baseline (Day 1):

    1. Conjunctival staining at ≥3 (out of a possible score of 6 per eye), and
    2. Schirmer test (with anesthesia) at ≥1 to ≤7mm in 5 minutes
  5. Symptomatic evidence of DED by having a global symptom score (Overall SANDE) ≥40 mm at Screening and Baseline (Day 1) visit
  6. Intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in each eye
  7. Women who satisfy one of the following:

8a. Are of child-bearing potential (WOCP) who are not pregnant or lactating and who are either abstinent or sexually active on an acceptable method of birth control for at least 4 weeks prior to Visit 1 and throughout the study (i.e., until Day 28), OR 8b. Are post-menopausal or have undergone a sterilization procedure

Exclusion Criteria:

  1. Allergic to brimonidine or any similar products, or excipients of brimonidine
  2. Use of contact lenses within 14 days prior to Screening visit or planned use during study
  3. Currently receiving brimonidine or other treatment for glaucoma or ocular hypertension or history of glaucoma surgery.
  4. Receiving or have received any experimental or investigational drug or device within 30 days prior to Screening visit
  5. Intraocular pressure <5 mmHg or >22 mmHg in either eye
  6. Active ocular infection or history of ocular herpetic keratitis
  7. History of neurotrophic keratitis or ocular neuropathic pain
  8. Any history of eyelid surgery or intraocular/ocular surgery within the past 3 months
  9. Punctal occlusion within 3 months prior to Screening visit or during study
  10. Corneal epithelial defect larger than 1 mm2 in either eye
  11. Have active drug/alcohol dependence or abuse history
  12. Are neonates, pregnant/lactating women, children, or others who may be considered vulnerable populations
  13. Received corticosteroid-containing eye drops within 14 days prior to Screening visit or planned use during study
  14. Any change in systemic corticosteroids/immunosuppressives, cyclosporine ophthalmic emulsion 0.05% (Restasis®), cyclosporine ophthalmic solution 0.09% (Cequa™), or lifitegrast ophthalmic solution 5% (Xiidra®) within 30 days prior to Screening visit or planned change during study
  15. In the opinion of Investigator or Study Coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops
  16. Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03785340


Contacts
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Contact: Kevin Berth 484-237-3398 kevin.berth@ocugen.com

Locations
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United States, California
Aesthetic Eye Care Institute/David Wirta, MD and Associates Recruiting
Newport Beach, California, United States, 92663
Contact: Kimberly Abbascia    949-650-1863    kimberly.abbascia@drwirta.com   
Martel Medical Eye Group Recruiting
Rancho Cordova, California, United States, 95670
Contact: Unsa Anwar    916-631-7860    unsa.marteleye@gmail.com   
United States, Florida
Rand Eye Institute Recruiting
Pompano Beach, Florida, United States, 33064
Contact: Gabreil Velazquez    561-756-2835    gv@randeye.com   
United States, Illinois
Chicago Cornea Consultants Recruiting
Hoffman Estates, Illinois, United States, 60169
Contact: Jim Nykaza    847-748-3553      
United States, Kansas
Heart of America Eye Care, P. A. Recruiting
Mission, Kansas, United States, 66204
Contact: Brandy Sage    913-362-3210    bsage@hoaeyes.com   
United States, Missouri
Ophthalmology Associates Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Debi Gravemann    314-966-3377    debi.gravemann@youreyedoc.com   
United States, Ohio
Apex Eye- Kenwood Recruiting
Cincinnati, Ohio, United States, 45236
Contact: Misty Bruser    513-745-9787    Misty.Bruser@apexeye.com   
Apex Eye-Montgomery Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Candace Hayes    513-561-5655    Candace.Hayes@apexeye.com   
Abrams Eye Center Recruiting
Cleveland, Ohio, United States, 44115
Contact: Margaret Smith    216-937-2020    psmith213@att.net   
United States, Pennsylvania
Scott and Christie Eyecare Associates Recruiting
Cranberry Township, Pennsylvania, United States, 16066
Contact: Nastasha Hidman    724-772-5420    nhindman@scottandchristie.com   
United States, Tennessee
Total Eye Care Recruiting
Memphis, Tennessee, United States, 38119
Contact: Daniel Ashe    901-761-4620    dashe6060tec@gmail.com   
Toyos Clinic Recruiting
Nashville, Tennessee, United States, 37215
Contact: Patricia Mathey    615-327-4015    pmathey@toyosclinic.com   
United States, Texas
Midtown Eye Physicans & Associates Recruiting
Houston, Texas, United States, 77004
Contact: Teresa Solis    281-338-0425    tmsolis@intouchcrc.com   
Advanced Laser Vision & Surgical Institute Recruiting
Houston, Texas, United States, 77034
Contact: Teresa Solis    281-338-0425    tmsolis@intouchcrc.com   
Revolution Research, Inc; Lake Travis Eye and Laser Center Recruiting
Lakeway, Texas, United States, 78734
Contact: Thomas Dykes    415-420-4650    tdykes@revolutionresearch.net   
United States, Utah
The Eye Institute of Utah Recruiting
Salt Lake City, Utah, United States, 84107
Contact: Laurie Admans    801-263-5735    ladams@theeyeinstitute.com   
Sponsors and Collaborators
Ocugen

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Responsible Party: Ocugen
ClinicalTrials.gov Identifier: NCT03785340     History of Changes
Other Study ID Numbers: OCU-310-301
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ocugen:
Dry Eye Disease

Additional relevant MeSH terms:
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Brimonidine Tartrate
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs