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

Adenoviral Conjunctivitis Clinical Trial

— Goldeneye  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03009799
• Other study ID #: NCX-4240-15001
• Status: Withdrawn
• Phase: Phase 2
• First received: December 12, 2016
• Last updated: May 9, 2017
• Start date: January 2017
• Est. completion date: September 2017

Study information

• Verified date: May 2017
• Source: NicOx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoviral Conjunctivitis
• Conjunctivitis

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	Hospital Clinico San Carlos	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
NicOx	Iris Pharma, Theradis pharma

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adenoplus test results	AdenoPlus® test results, testing the studied eye at each post baseline visits.	21 days
Secondary	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
Secondary	Investigator's assessment of Membranes and pseudomembranes development	For both eyes: timing of occurrence if any	21 days
Secondary	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
Secondary	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
Secondary	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
Secondary	BCVA	Best corrected far Visual Acuity for both eyes (Day 1, 7, 14 and Day 21).	21 days
Secondary	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
Secondary	Adverse events	Safety parameters (Adverse Events/Serious Adverse Events)	21 days