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Trial record 10 of 19 for:    Nicox

Efficacy and Safety of Iota-Carrageenan Eye Drops (NCX-4240) (Goldeneye)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2017 by NicOx
Sponsor:
Collaborators:
Iris Pharma
Theradis pharma
Information provided by (Responsible Party):
NicOx
ClinicalTrials.gov Identifier:
NCT03009799
First received: December 12, 2016
Last updated: January 2, 2017
Last verified: January 2017
  Purpose
This clinical investigation aims at demonstrating that NCX-4240 is effective and safe in decreasing the number of days where adenoviral conjunctivis is detected in the eye and in reducing the duration and/or the severity of the signs and symptoms of adenoviral conjunctivis

Condition Intervention Phase
Adenoviral Conjunctivitis
Drug: Iota-Carrageenan
Drug: Carmellose
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of Iota-Carrageenan Eye Drops (NCX-4240) Versus Placebo in Patients With Adenoviral Conjunctivis

Resource links provided by NLM:


Further study details as provided by NicOx:

Primary Outcome Measures:
  • Viral eradication time NCX 4240 versus Placebo [ Time Frame: 21 days ]
    Comparison in time to viral eradication in NCX-4240 and the placebo groups (when virus load is 0 or BLD - below the limit of detection) from the tears as measured by Polymerase Chain Reaction (PCR) at each visit.


Secondary Outcome Measures:
  • Quantitative PCR [ Time Frame: 21 days ]
    1) Quantitative PCR (qPCR) results at all clinical investigation timepoints 4) Global patient discomfort with Likert 4 points scales: no discomfort - minimal - moderate - severe discomfort, assessed every day in the Patient's diary 5) Ocular signs as assessed by the investigators at each visit and for both eyes

  • Impact on daily activities [ Time Frame: 21 days ]

    Impact of the disease on daily activities as measured by the patient daily with a 4 points Likert scale (no - minimal - moderate - severe) 5) Ocular signs as assessed by the investigators at each visit and for both eyes:

    • Degree of bulbar conjunctival injection/hyperaemia will be graded using the Mc Monnies grading scale for conjunctival hyperaemia
    • Other signs will be assessed with Likert 5 points scales: none - traces - mild - moderate - severe for chemosis (conjunctival edema), follicles, petechiae, and keratitis. Presence/absence of loco-regional lymphadenopathies will also be recorded

  • Patient discomfort [ Time Frame: 21 days ]
    Global patient discomfort with Likert 4 points scales: no discomfort - minimal - moderate - severe discomfort, assessed every day in the Patient's diary

  • bulbar conjuntival infection [ Time Frame: 21 days ]
    Ocular signs as assessed by the investigators at each visit and for both eyes: degree of bulbar conjunctival infection/hyperaemia will be graded using the McMonnies grading scale for conjunctival hypereaemia.

  • Other signs to be assessed [ Time Frame: 21 days ]

    Ocular signs as assessed by the investigators at each visit and for both eyes:

    - Other signs will be assessed with Likert 5 points scales: none - traces - mild - moderate - severe for chemosis (conjunctival edema), follicles, petechiae, and keratitis.


  • loco-regional lymphadenopathies [ Time Frame: 21 days ]

    Ocular signs as assessed by the investigators at each visit and for both eyes:

    Presence/absence of loco-regional lymphadenopathies


  • Ocular symptoms assessed by patients [ Time Frame: 21 days ]
    Ocular symptoms as assessed by the patients in the patient diary: self-rated daily for 21 days: symptoms sum-score of pain, foreign body sensation, itchy eye(s), photophobia/light sensitivity, ocular secretions and eyelash matting. Assessments will be performed with Likert 5 points scales (none - traces - mild - moderate - severe).

  • Disease impact on daily activities [ Time Frame: 21 days ]
    Impact of the disease on daily activities as measured by the patient daily with a 4 points Likert scale (no - minimal - moderate - severe)

  • Global patient discomfort [ Time Frame: 21 days ]
    Global patient discomfort with Likert 4 points scales: no discomfort - minimal - moderate - severe discomfort, assessed every day in the Patient's diary

  • Adenoplus test results [ Time Frame: 21 days ]
    AdenoPlus® test results, testing the studied eye at each post baseline visits.

  • Investigator's assessment of Membranes and pseudomembranes development [ Time Frame: 21 days ]
    For both eyes: Development of membranes, pseudomembranes assessed by the investigator, incidence and severity (none - mild - moderate - severe)

  • Investigator's assessment of Membranes and pseudomembranes development [ Time Frame: 21 days ]
    For both eyes: timing of occurrence if any

  • Investigator's assessment of Subepithelial Corneal Infiltrates development [ Time Frame: 21 days ]
    For both eyes: Development of subepithelial corneal infiltrates (none - mild - moderate - severe) as assessed by the investigator

  • Investigator's assessment of Subepithelial Corneal Infiltrates development [ Time Frame: 21 days ]
    For both eyes: Development of subepithelial corneal infiltrates: timing of occurrence as assessed by the investigator examination

  • Assessment of Incidence and severity of fellow eye signs and symptoms [ Time Frame: 21 days ]
    If only one eye is affected (signs and symptoms) at baseline, assessment of the incidence and severity of the other eye signs and symptoms by the investigator

  • BCVA [ Time Frame: 21 days ]
    Best corrected far Visual Acuity for both eyes (Day 1, 7, 14 and Day 21).

  • Global assessment of patient's satisfaction [ Time Frame: 21 days ]
    Global assessment of the patient's satisfaction with the eye drops use with a 4 points Likert scale: poor, fair, good, excellent, will be performed at Day 7, 14 and 21

  • Adverse events [ Time Frame: 21 days ]
    Safety parameters (Adverse Events/Serious Adverse Events)


Estimated Enrollment: 148
Study Start Date: January 2017
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Eye drops containing Iota-Carrageenan
Eye drops 3.2mg/ml
Drug: Iota-Carrageenan
One drop in each eye 8 times per day for 7 days (mandatory), then 4 to 8 times/day for the next 14 days until Day 21
Other Name: NCX-4240
Placebo Comparator: Ocular Lubricant Eye Drops
Carmellose 0.5% sterile solution
Drug: Carmellose
1 drop in each eye 8 times/day for 7 days (mandatory), then 4 to 8 times/day for the next 14 days until day 21
Other Name: Placebo

Detailed Description:

A multicenter, double masked, parallel, randomized 1:1 ratio clinical investigation comparing carrageenan eye drops (NCX 4240) versus placebo up to 21 days.

Total expected number of patients: 148

Randomization: patients will be randomized 1:1 between:

  • Group A: eye drops containing iota-carrageenan (NCX 4240), 1 drop in each eye 8 times/day for 7 days (mandatory) then at least 4 to 8 times/day for the next 14 days until Day 21 or
  • Group B: ocular lubricant eye drop (carmellose 0.5% sterile solution) 1 drop in each eye 8 times/day for 7 days (Mandatory), then 4 to 8 times/day for the next 14 days until Day 21.
  Eligibility

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

Inclusion Criteria:

  • With uni-or bilateral acute adenoviral conjunctivis as diagnostised with adenoplus test
  • Conjunctivis signs and symptoms in at least one eye AND positive adenoplus test in at least one eye whatever signs/symptoms and positive adenoplus test are from the same eye or not

Exclusion Criteria:

  • Negative results with adenoplus test in both eyes
  • a suspected bacterial, fungal, herpes, chlamydia or acanthamoeba co-infection, based on clinical investigation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03009799

Contacts
Contact: Brigitte Duquesroix 3349724 ext 5366 duquesroix@nicox.com
Contact: Marina Marciano 3349724 ext 5371 marciano@nicox.com

Locations
Spain
Hospital Clinico San Carlos Not yet recruiting
Madrid, Spain, 28040
Contact: Benitez Del Castillo, Pr         
Sponsors and Collaborators
NicOx
Iris Pharma
Theradis pharma
Investigators
Study Director: Brigitte Duquesroix NicOx
  More Information

Responsible Party: NicOx
ClinicalTrials.gov Identifier: NCT03009799     History of Changes
Other Study ID Numbers: NCX-4240-15001
Study First Received: December 12, 2016
Last Updated: January 2, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by NicOx:
adenoviral conjunctivis
iota-carrageenan

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Inclusion
Conjunctival Diseases
Eye Diseases
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Infection
Ophthalmic Solutions
Tetrahydrozoline
Carboxymethylcellulose Sodium
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Laxatives
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 21, 2017