Trial · NCT02855450

Study to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution Versus Vehicle in Patients With Glaucoma

NCT02855450, Phase 1, Completed, Dompé Farmaceutici S.p.A; results first posted 2020-11-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution Versus Vehicle in Patients With Glaucoma. Trials, record NCT02855450. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02855450

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution Versus Vehicle in Patients With Glaucoma
NCT number: NCT02855450
Status: Completed
Phases: Phase 1
Enrollment: 60 participants, actual
Lead sponsor: Dompé Farmaceutici S.p.A
Conditions: Glaucoma
Interventions: rhNGF, Vehicle
First posted: 2016-08-04
Last updated: 2020-11-25
Results first posted: 2020-11-25

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Incidence of Events as of Primary Safety Outcomes	At day 56/end of treatment	Unexpected Severe Progression Of Optic Neuropathy (USPON) is a composed parameter which required at least 28 single evaluations; it occurred if the subject answered Yes to any of the following 4 questions on unexpected severe progression: * Best Corrected Distance Visual Acuity (BCDVA): 'Yes' for at least one treated eye at any Follow-Up Visit after first study drug dose * Humphrey Visual Field (HVF): 'Yes' for at least one treated eye in at least one assessment during treatment or follow-up period * Electroretinography (ERG): 'Yes' for at least one treated eye at any Follow-Up Visit after first study drug dose * Optical Coherence tomography (OCT): 'Yes' for at least one treated eye at any Follow-Up Visit after first study drug dose Intolerance and allergy to the drug was identified based on preferred term of treatment-emergent adverse events. URAEs are unexpected related AE affecting ocular function. Local/systemic toxicities were identified via the AE form
Primary	Change From Baseline in Visual Analogue Scale (VAS) Ocular Tolerability Score	Change from baseline to days 7, 28 and 56 (Treatment period), and Day 84 (Follow up)	A ocular tolerability score was determined using a 100 mm VAS on which 0 meant No symptoms and 100 meant the Worst possible discomfort. The patients subjectively evaluated their ocular symptoms (foreign body sensation, burning or stinging, itching, pain, sticky feeling, blurred vision and photophobia) using the VAS giving the value they were feeling from none to an extreme value. The ocular symptoms were evaluated by the patients through the scale. Only "overall" values for primary eye and secondary eye are reported here under. An eye was considered as Primary eye, if * the eye was treated and * the investigator considered this eye as qualifying eye. * If both eyes were considered as qualifying eye, the right eye was chosen. The other eye was then considered as Secondary eye, if the eye was treated.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence of Events as of Primary Safety Outcomes	At day 56/end of treatment	Safety Set (SAF). The Safety Set includes all randomized subjects who received at least one dose of study medication. This safety population is used in the analysis of all safety endpoints. All analyses based on the SAF are summarized by the treatment received	Number of events	NUMBER
PRIMARY	Change From Baseline in Visual Analogue Scale (VAS) Ocular Tolerability Score	Change from baseline to days 7, 28 and 56 (Treatment period), and Day 84 (Follow up)	The Safety Set includes all randomized subjects who received at least one dose of study medication. This safety population is used in the analysis of all safety endpoints. All analyses based on the SAF are summarized by the treatment received.~Please note that there were major protocol deviations, so that no complete VAS data was reported during treatment period; for this reason the numbers of participants analyzed per row may differ from the Overall Numbers of Participants.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group26

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Incidence of Events as of Primary Safety Outcomes	rhNGF	USPON	0	Number of events
Incidence of Events as of Primary Safety Outcomes	Vehicle	USPON	2	Number of events
Incidence of Events as of Primary Safety Outcomes	rhNGF	USPON during treatment period	0	Number of events
Incidence of Events as of Primary Safety Outcomes	Vehicle	USPON during treatment period	0	Number of events
Incidence of Events as of Primary Safety Outcomes	rhNGF	Intolerance to the drug	6	Number of events
Incidence of Events as of Primary Safety Outcomes	Vehicle	Intolerance to the drug	0	Number of events
Incidence of Events as of Primary Safety Outcomes	rhNGF	Ocular URAEs	1	Number of events
Incidence of Events as of Primary Safety Outcomes	Vehicle	Ocular URAEs	1	Number of events
Incidence of Events as of Primary Safety Outcomes	rhNGF	Local/systemic toxicities	0	Number of events
Incidence of Events as of Primary Safety Outcomes	Vehicle	Local/systemic toxicities	0	Number of events

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	rhNGF	40
Overall Study	STARTED	Vehicle	20
Overall Study	COMPLETED	rhNGF	35
Overall Study	COMPLETED	Vehicle	20
Overall Study	NOT COMPLETED	rhNGF	5
Overall Study	NOT COMPLETED	Vehicle	0

Source ClinicalTrials.gov

Adverse events108

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Eye pain	Eye disorders	rhNGF	21	40	26
other	Eye pain	Eye disorders	Vehicle	2	20	2
other	Eye irritation	Eye disorders	rhNGF	6	40	7
other	Eye irritation	Eye disorders	Vehicle	3	20	3
other	Photophobia	Eye disorders	rhNGF	8	40	8
other	Photophobia	Eye disorders	Vehicle	0	20	0
other	Conjunctival hyperaemia	Eye disorders	rhNGF	3	40	4
other	Conjunctival hyperaemia	Eye disorders	Vehicle	1	20	1
other	Blepharitis	Eye disorders	rhNGF	3	40	3
other	Blepharitis	Eye disorders	Vehicle	1	20	1

1 to 10 of 108Source ClinicalTrials.gov

See all 108 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	rhNGF	0	40
Total, all-cause mortality	Vehicle	0	20
Total, other adverse events	rhNGF	31	40
Total, other adverse events	Vehicle	9	20
Total, serious adverse events	rhNGF	3	40
Total, serious adverse events	Vehicle	2	20

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34780798	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
rhNGF vs Vehicle: deaths from any cause	Trial comparisons
rhNGF vs Vehicle: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT02855450/results?page=2

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