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Dry Eye Disease Study With Brimonidine

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ClinicalTrials.gov Identifier: NCT03418727
Recruitment Status : Completed
First Posted : February 1, 2018
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Ocugen

Tracking Information
First Submitted Date  ICMJE October 10, 2017
First Posted Date  ICMJE February 1, 2018
Last Update Posted Date July 10, 2018
Actual Study Start Date  ICMJE September 6, 2017
Actual Primary Completion Date March 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2018)
Main Objective (Tolerability) [ Time Frame: Baseline - Day 84 ]
Subjects will assess their tolerance to the administration of the study drug, utilizing a Visual Analogue Scale (VAS). The VAS is a 100-mm horizontal line with verbal descriptors at either end. The VAS ratings will be completed after administration of the study drug on Day 1 (post-dose), Day 28, Day 56, and Day 84,. Subjects will place a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03418727 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dry Eye Disease Study With Brimonidine
Official Title  ICMJE A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Proof-of-Concept Study of Brimonidine Eye Drops for the Treatment of Dry Eye Disease (DED)
Brief Summary To evaluate the tolerability and preliminary efficacy of Brimonidine eye drops (with and without corticosteroid eye drops) for the treatment of Dry Eye Disease (DED).
Detailed Description Subjects will assess their tolerance to the administration of the study drug, utilizing a Visual Analog Scale (VAS). The VAS is a 100-mm horizontal line with verbal descriptors at either end. The VAS ratings will be completed after administration of the study drug on Day 1 (post-dose), Day 28, Day 56, Day 84, and Day 105. Subjects will place a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye
Intervention  ICMJE
  • Drug: Brimonidine
    Two products delivered in sequence twice daily.
  • Drug: Brimonidine Mono Therapy
    Brimonidine given twice daily along with placebo drops
  • Drug: sodium carboxymethylcellulose
    Placebo given twice daily.
  • Drug: Corticosteroid Eye Drop
    Eye drop to be administered after Briomonidine in treatment arm 1
Study Arms  ICMJE
  • Experimental: Study Drug Arm #1
    Combination Therapy: brimonidine (0.2%) administered as eye drops, followed by corticosteroid eye drops, two times a day (BID) for 12 weeks
    Interventions:
    • Drug: Brimonidine
    • Drug: Corticosteroid Eye Drop
  • Experimental: Study Drug Arm #2
    Monotherapy: brimonidine (0.2%) administered as eye drops followed by placebo, two times a day (BID) for 12 weeks
    Intervention: Drug: Brimonidine Mono Therapy
  • Placebo Comparator: Control Arm
    Placebo: sodium carboxymethylcellulose (0.25%) administered as eye drops followed by a second application, two time a day (BID) for 12 weeks
    Intervention: Drug: sodium carboxymethylcellulose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2018)
84
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2018)
90
Actual Study Completion Date  ICMJE March 29, 2018
Actual Primary Completion Date March 29, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  4. Objective evidence of DED in at least one eye by having 2 or more of the following 4 signs in the same eye at Screening and Baseline (Day 1) visits:

    i. Conjunctival staining at >/= 1 (out of a possible score of 6 per eye) ii. Corneal staining at >/= 2 (out of a possible score of 15 per eye) iii. Noninvasive Tear Break-Up Time (NITBUT) at </= 7 seconds iv. Schirmer test at <10mm in 5 minutes

  5. Symptomatic evidence of DED by having a global symptom score (SANDE) >/= 25 mm at both Screening and Baseline (Day 1) visits
  6. Intraocular pressure (IOP) >/= 5 mmHg and </= 22 mmHg in each eye
  7. Women who satisfy one of the following:

    1. 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, OR
    2. Are post-menopausal or have undergone a sterilization procedure

Exclusion Criteria:

  1. Allergic to brimonidine, corticosteroids or any similar products, or excipients of brimonidine including benzalkonium chloride (BAK)
  2. Use of contact lenses
  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, institutionalized individuals, or others who may be considered vulnerable populations
  13. Received corticosteroid-containing eye drops within the past 7 days or systemic corticosteroids/immunosuppressives within the past 3 months
  14. Received cyclosporine ophthalmic emulsion 0.05% (Restasis®) or lifitegrast ophthalmic solution 5% (Xiidra™) within 30 days prior to Screening visit
  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03418727
Other Study ID Numbers  ICMJE OCU-310-DED-2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ocugen
Study Sponsor  ICMJE Ocugen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kevin Berth Ocugen
PRS Account Ocugen
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP