Adenoviral ConjunctivitisPhase 2GoldeneyeNCT03009799
Efficacy and Safety of Iota-Carrageenan Eye Drops (NCX-4240)
A Phase 2 study testing Iota-Carrageenan and Carmellose in people with Adenoviral Conjunctivitis, run by NicOx at 1 site in Spain.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenoviral Conjunctivitis
- What is being tested?
- Iota-Carrageenan and Carmellose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2017to Sep 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Negative results with adenoplus test in both eyes
- a suspected bacterial, fungal, herpes, chlamydia or acanthamoeba co-infection, based on clinical investigation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Adenoviral Conjunctivitis
- Being tested
- Iota-Carrageenan, Carmellose
- Keywords
- adenoviral conjunctivis, iota-carrageenan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iota-CarrageenanDrug
Also called NCX-4240
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
CarmelloseDrug
Also called Placebo
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 group | Role | What they receive |
|---|---|---|
| Eye drops containing Iota-Carrageenan | Active comparator | Eye drops 3.2mg/ml Receives: Drug: Iota-Carrageenan |
| Ocular Lubricant Eye Drops | Placebo comparator | Carmellose 0.5% sterile solution Receives: Drug: Carmellose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 21 days
Secondary outcomes (18)
Quantitative PCR
- 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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)
Measured: 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
Measured: 21 days
Adenoplus test results
AdenoPlus® test results, testing the studied eye at each post baseline visits.
Measured: 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)
Measured: 21 days
Investigator's assessment of Membranes and pseudomembranes development
For both eyes: timing of occurrence if any
Measured: 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
Measured: 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
Measured: 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
Measured: 21 days
BCVA
Best corrected far Visual Acuity for both eyes (Day 1, 7, 14 and Day 21).
Measured: 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
Measured: 21 days
Adverse events
Safety parameters (Adverse Events/Serious Adverse Events)
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionAug 2017 (estimated)
- Study completionSep 2017 (estimated)
Why it stopped: Study stopped following management decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoviral ConjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NicOx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Iris Pharma, Theradis pharma
- Responsible party
- Sponsor
- Investigators
- Brigitte Duquesroix, Study director, NicOx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009799
- Sponsor's protocol ID
- NCX-4240-15001
- Acronym
- Goldeneye
- Status last verified
- May 2017
- First submitted
- 12 Dec 2016
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Iota-Carrageenan Eye Drops (NCX-4240) Versus Placebo in Patients With Adenoviral Conjunctivis
- ClinicalTrials.gov ID
- NCT03009799
- Acronym / sponsor ID
- Goldeneye / NCX-4240-15001
- Conditions
- Adenoviral Conjunctivitis
- Keywords
- adenoviral conjunctivis, iota-carrageenan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study stopped following management decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NicOxIndustry (pharma, biotech, devices)
- Collaborators
- Iris Pharma, Theradis pharma
- Study start
- Jan 2017
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 4 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eye drops containing Iota-Carrageenan | Active comparator | Drug: Iota-CarrageenanEye drops 3.2mg/ml |
| Ocular Lubricant Eye Drops | Placebo comparator | Drug: CarmelloseCarmellose 0.5% sterile solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Negative results with adenoplus test in both eyes
- a suspected bacterial, fungal, herpes, chlamydia or acanthamoeba co-infection, based on clinical investigation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iota-CarrageenanAlso: NCX-4240One 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 | Drug | Eye drops containing Iota-Carrageenan |
| CarmelloseAlso: Placebo1 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 | Drug | Ocular Lubricant Eye Drops |
Primary outcome
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.
18 secondary outcomes
Quantitative PCR
Time frame: 21 days
Impact on daily activities
Time frame: 21 days
Patient discomfort
Time frame: 21 days
bulbar conjuntival infection
Time frame: 21 days
Other signs to be assessed
Time frame: 21 days
loco-regional lymphadenopathies
Time frame: 21 days
Ocular symptoms assessed by patients
Time frame: 21 days
Disease impact on daily activities
Time frame: 21 days
Global patient discomfort
Time frame: 21 days
Adenoplus test results
Time frame: 21 days
Investigator's assessment of Membranes and pseudomembranes development
Time frame: 21 days
Investigator's assessment of Membranes and pseudomembranes development
Time frame: 21 days
Investigator's assessment of Subepithelial Corneal Infiltrates development
Time frame: 21 days
Investigator's assessment of Subepithelial Corneal Infiltrates development
Time frame: 21 days
Assessment of Incidence and severity of fellow eye signs and symptoms
Time frame: 21 days
BCVA
Time frame: 21 days
Global assessment of patient's satisfaction
Time frame: 21 days
Adverse events
Time frame: 21 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte Duquesroix study director
NicOx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iota-Carrageenan and Carmellose in people with Adenoviral Conjunctivitis, run by NicOx at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral eradication time NCX 4240 versus Placebo (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.