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

Evaluation of the Efficacy and Safety of Iota-Carrageenan Eye Drops (NCX-4240) Versus Placebo in Patients With Adenoviral Conjunctivis

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

Study Overview

• Status: Withdrawn
• Conditions: Adenoviral Conjunctivitis
• Intervention / Treatment: Drug: Iota-Carrageenan; Drug: Carmellose

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viral eradication time NCX 4240 versus Placebo	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.	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative PCR	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	21 days
Impact on daily activities	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	21 days
Patient discomfort	Global patient discomfort with Likert 4 points scales: no discomfort - minimal - moderate - severe discomfort, assessed every day in the Patient's diary	21 days
bulbar conjuntival infection	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.	21 days
Other signs to be assessed	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.	21 days
loco-regional lymphadenopathies	Ocular signs as assessed by the investigators at each visit and for both eyes: Presence/absence of loco-regional lymphadenopathies	21 days
Ocular symptoms assessed by patients	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).	21 days
Disease impact on daily activities	Impact of the disease on daily activities as measured by the patient daily with a 4 points Likert scale (no - minimal - moderate - severe)	21 days
Global patient discomfort	Global patient discomfort with Likert 4 points scales: no discomfort - minimal - moderate - severe discomfort, assessed every day in the Patient's diary	21 days
Adenoplus test results	AdenoPlus® test results, testing the studied eye at each post baseline visits.	21 days
Investigator's assessment of Membranes and pseudomembranes development	For both eyes: Development of membranes, pseudomembranes assessed by the investigator, incidence and severity (none - mild - moderate - severe)	21 days
Investigator's assessment of Membranes and pseudomembranes development	For both eyes: timing of occurrence if any	21 days
Investigator's assessment of Subepithelial Corneal Infiltrates development	For both eyes: Development of subepithelial corneal infiltrates (none - mild - moderate - severe) as assessed by the investigator	21 days
Investigator's assessment of Subepithelial Corneal Infiltrates development	For both eyes: Development of subepithelial corneal infiltrates: timing of occurrence as assessed by the investigator examination	21 days
Assessment of Incidence and severity of fellow eye signs and symptoms	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	21 days
BCVA	Best corrected far Visual Acuity for both eyes (Day 1, 7, 14 and Day 21).	21 days
Global assessment of patient's satisfaction	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	21 days
Adverse events	Safety parameters (Adverse Events/Serious Adverse Events)	21 days

Collaborators and Investigators

• Sponsor: NicOx
• Collaborators: Theradis pharma; Iris Pharma
• Investigators: Study Director: Brigitte Duquesroix, nicox

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: January 2, 2017
• First Posted (Estimate): January 4, 2017

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: adenoviral conjunctivis; iota-carrageenan
• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Conjunctivitis; Gastrointestinal Agents; Laxatives; Carboxymethylcellulose Sodium
• Other Study ID Numbers: NCX-4240-15001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided