Study Stopped
Study stopped following management decision
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
1 other identifier
interventional
N/A
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2017
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedFirst Posted
Study publicly available on registry
January 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedMay 10, 2017
May 1, 2017
7 months
December 12, 2016
May 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (18)
Quantitative PCR
21 days
Impact on daily activities
21 days
Patient discomfort
21 days
bulbar conjuntival infection
21 days
Other signs to be assessed
21 days
- +13 more secondary outcomes
Study Arms (2)
Eye drops containing Iota-Carrageenan
ACTIVE COMPARATOREye drops 3.2mg/ml
Ocular Lubricant Eye Drops
PLACEBO COMPARATORCarmellose 0.5% sterile solution
Interventions
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
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- Negative results with adenoplus test in both eyes
- a suspected bacterial, fungal, herpes, chlamydia or acanthamoeba co-infection, based on clinical investigation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NicOxlead
- Iris Pharmacollaborator
- Theradis pharmacollaborator
Study Sites (1)
Hospital Clinico San Carlos
Madrid, 28040, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Brigitte Duquesroix
NicOx
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2016
First Posted
January 4, 2017
Study Start
January 1, 2017
Primary Completion
August 1, 2017
Study Completion
September 1, 2017
Last Updated
May 10, 2017
Record last verified: 2017-05