Ocular DiscomfortPhase 2NCT03035864

A 8 Weeks Study to Evaluate Efficacy & Safety of rhNGF vs Vehicle in Patients After Cataract and Refractive Surgery

A Phase 2 study testing rhNGF in people with Ocular Discomfort, run by Dompé Farmaceutici S.p.A at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective of this exploratory study is to assess preliminary efficacy and safety of rhNGF when administered as eye drops to patients after cataract and refractive surgery. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ocular Discomfort
What is being tested?: rhNGF
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: 1 siteItaly
Study dates: 12 Jan 2017to 4 Sep 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Male or female ≥18 years old
Patients who are characterized by the following clinical features:
History of cataract or refractive corneal surgery in the study eye(s) in the previous 6 months;
Mean Symptom Assessment in Dry Eye (SANDE) score for severity and frequency of at least 30 at baseline
The same eye (study eye) must fulfill all the above criteria
Best corrected distance visual acuity (BCDVA) score of ≥ 0.1 decimal units in both eyes at the time of study enrolment

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Female patients must have negative pregnancy urine test if at childbirth potential.
Only patients who satisfy all requirements for informed consent may be included in the study. Written Informed Consent must be obtained before the initiation of any study-specific procedures.
Patients must have the ability and willingness to comply with study procedures

Who cannot join

Any ocular disease other than Dry Eye requiring treatment with topical medications in either eye at the time of study enrolment.
Any active ocular infection or active inflammation in either eye unrelated to Dry Eye.
Presence or history of any systemic or ocular disorder, condition or disease (with particular attention to malignancies and neuro-oncological diseases) that could possibly interfere with the conduct of the required study procedures or the interpretation of the study results.
Use of therapeutic or Refractive Contact lenses in either eye at the time of study enrolment;
History of ocular surgery in the study eye(s), excluding corneal refractive or cataract procedures, within 90 days of study enrolment.
Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions:

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are currently pregnant or,
have a positive result at the urine pregnancy test (Baseline/Day 0) or,
intend to become pregnant during the study treatment period or,
are breast-feeding or,
are not willing to use highly effective birth control measures, such as: hormonal contraceptives - oral, implanted, transdermal, or injected - and/or mechanical barrier methods - spermicide in conjunction with a barrier such as a condom or diaphragm or IUD (Intrauterine device) - during the entire course of and 30 days after the study treatment periods.
Participation in another clinical study at the same time as the present and within 30 days of study enrolment;
History of drug, medication or alcohol abuse or addiction.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Univ. G. D'Annunzio-Clinica Oftalmologica-Chieti
Chieti

Other trials in Italy

About this study

Official title: A 8 Weeks, Phase II, Single-centre, Randomized, Double-masked, Vehicle-controlled, Parallel Group Study With 4 Weeks Follow-up to Evaluate Efficacy & Safety of rhNGF Eye Drops vs Vehicle in Patients After Cataract and Refractive Surgery

The primary objective of this exploratory study is to assess preliminary efficacy and safety of rhNGF when administered as eye drops to patients after cataract and refractive surgery.

The main criteria for evaluation were:

Change from baseline in SANDE scores for severity and frequency assessed at 8 weeks of treatment (primary efficacy endpoint)
Changes in Cornea vital staining with fluorescein (National Eye Institute [NEI] scales) assessed at 8 weeks of treatment (co-primary efficacy endpoint)
Changes in conjunctiva vital staining with fluorescein (NEI scales) (secondary efficacy endpoint);
Changes in Tear Film Break-Up Time (TFBUT)(secondary efficacy endpoint);
Changes in Cochet-Bonnet corneal aesthesiometry (secondary efficacy endpoint);
Changes in Nerve count and morphology at scanning laser in vivo corneal confocal microscopy (only patients who had Laser-Assisted In situ Keratomileusis [LASIK] surgery) (secondary efficacy endpoint);
Changes in SANDE scores (face values) for severity and frequency (secondary efficacy endpoint);
Incidence and frequency of treatment-emergent adverse events (TEAEs), assessed throughout the study (safety endpoint).

Read the detailed description

The proposed phase II study is a single-centre, randomized, double masked, parallel arm, vehicle-controlled trial, designed to evaluate the preliminary efficacy and safety of rhNGF eye drops at 20 µg/ml concentration administered six times daily for 8 weeks in patients who underwent cataract and corneal refractive surgery, both known to damage the corneal sensory nerve plexus.

After confirmation of inclusion and exclusion criteria all eligible patients will be randomized at 2:1 ratio to rhNGF or vehicle control treatment with 8 weeks of study treatments administration with 4 weeks Follow-up.

Conditions: Ocular Discomfort
Being tested: rhNGF, Vehicle
Keywords: Ocular discomfort after cataract and refractive surgery, cataract surgery, refractive surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rhNGFDrug
Also called NGF
Eye Drop 20 μg/mL
VehicleOther
Vehicle Eye Drop

Study groups in NCT03035864
Study group	Role	What they receive
rhNGF 20 µg/ml	Experimental	Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily Receives: Drug: rhNGF
Vehicle	Placebo comparator	Vehicle eye drops six times daily Receives: Other: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in SANDE Scores for Frequency and Severity Assessed at 8 Weeks of Treatment.
The Symptom Assessment in Dry Eye (SANDE) questionnaire is a short questionnaire to evaluate both dry eye intensity and frequency by using a 100 mm visual analogue scale (VAS). The patient symptoms of ocular dryness and/or irritation were quantified on the scale based on two questions that assessed both the severity and frequency of symptoms.
The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
Measured: Baseline and Week 8
Changes in Cornea Vital Staining With Fluorescein (National Eye Institute [NEI] Scales)
Corneal Staining was derived as the sum of scores of the five corneal sectors (central, superior, inferior, nasal, and temporal) each of which was scored on a scale of 0-3, with a minimum score of 0 and a maximal score of 15 (sum > 3 out of 15 is abnormal).
Measured: Baseline and Week 8

Secondary outcomes (4)

Changes in Conjunctiva Vital Staining With Fluorescein (National Eye Institute [NEI] Scales)
Conjunctival Staining was derived as the sum of scores of the conjunctival area (nasal-superior paralimbal, nasal-inferior paralimbal, nasal-peripheral, temporal-superior paralimbal, temporal-inferior paralimbal, temporal-peripheral) with a grading scale of 0-3 and with a minimum score of 0 and a maximal score of 18 (18 indicates the most abnormal score). Grades increase with the number and density of dots.
Data for the main eye are reported.
Measured: From baseline to weeks 4, 8 and 12
Changes in Tear Film Break-Up Time (TFBUT)
The TFBUT measurement was performed after instillation of 5 microliters of 2% sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient was instructed to blink several times to thoroughly mix the fluorescein with the tear film.
Data for the main eye are reported.
Measured: From baseline to weeks 4, 8 and 12
Changes in Cochet-Bonnet Corneal Aesthesiometry
Corneal sensation was measured in both eyes in each of the four quadrants of the cornea using the Cochet Bonnet aesthesiometer before the instillation of any dilating or anesthetic eye drops. The handheld esthesiometer (Cochet-Bonnet) is a device that contains a thin, retractable, nylon monofilament that extends up to 6 cm in length. Variable pressure can be applied by the device by adjusting the length. The monofilament ranges from 60 mm to 5 mm and as the length is decreased the pressure increases from 11 mm/gm to 200 mm/gm.
Data for the main eye are reported.
Measured: From baseline to week 8
Changes in SANDE Scores (Face Values) for Frequency and Severity
The Symptom Assessment in Dry Eye (SANDE) questionnaire is a short questionnaire to evaluate both dry eye intensity and frequency by using a 100 mm visual analogue scale (VAS). The patient symptoms of ocular dryness and/or irritation were quantified on the scale based on two questions that assessed both the severity and frequency of symptoms.
The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
Measured: From baseline to weeks 4, 8 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jan 20174 Sep 2017

First posted30 Jan 2017 (estimated)
Study start12 Jan 2017
Primary completion4 Sep 2017
Study completion4 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ocular DiscomfortStudies 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: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03035864
Sponsor's protocol ID: NGF0116
Status last verified: Dec 2023
First submitted: 23 Jan 2017
Last updated: 19 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease
Dry Eye Disease (DED)
Not yet recruitingPhase 4
Contact Lens-Wearing Dry Eye Subjects Who Are Treated With Acoltremon 0.003%
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Recruiting
Treating Contact Lens Discomfort With Varenicline Solution Nasal Spray 0.03mg
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Efficacy of Kera Sol Tears on Signs and Symptoms of Surgical Temporary Ocular Discomfort Syndrome (STODS) in Subjects Following LASIK
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All Ocular Discomfort trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 8 Weeks, Phase II, Single-centre, Randomized, Double-masked, Vehicle-controlled, Parallel Group Study With 4 Weeks Follow-up to Evaluate Efficacy & Safety of rhNGF Eye Drops vs Vehicle in Patients After Cataract and Refractive Surgery
ClinicalTrials.gov ID: NCT03035864
Acronym / sponsor ID: NGF0116
Conditions: Ocular Discomfort
Keywords: Ocular discomfort after cataract and refractive surgery, cataract surgery, refractive surgery
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Dompé Farmaceutici S.p.AIndustry (pharma, biotech, devices)
Study start: 12 Jan 2017 (actual)
Primary completion: 4 Sep 2017 (actual)
Study completion: 4 Sep 2017 (actual)
First posted: 30 Jan 2017 (estimated)
Results: Posted 22 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective of this exploratory study is to assess preliminary efficacy and safety of rhNGF when administered as eye drops to patients after cataract and refractive surgery.

The main criteria for evaluation were:

Change from baseline in SANDE scores for severity and frequency assessed at 8 weeks of treatment (primary efficacy endpoint)
Changes in Cornea vital staining with fluorescein (National Eye Institute [NEI] scales) assessed at 8 weeks of treatment (co-primary efficacy endpoint)
Changes in conjunctiva vital staining with fluorescein (NEI scales) (secondary efficacy endpoint);
Changes in Tear Film Break-Up Time (TFBUT)(secondary efficacy endpoint);
Changes in Cochet-Bonnet corneal aesthesiometry (secondary efficacy endpoint);
Changes in Nerve count and morphology at scanning laser in vivo corneal confocal microscopy (only patients who had Laser-Assisted In situ Keratomileusis [LASIK] surgery) (secondary efficacy endpoint);
Changes in SANDE scores (face values) for severity and frequency (secondary efficacy endpoint);
Incidence and frequency of treatment-emergent adverse events (TEAEs), assessed throughout the study (safety endpoint).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
rhNGF 20 µg/ml	Experimental	Drug: rhNGFRecombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
Vehicle	Placebo comparator	Other: VehicleVehicle eye drops six times daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male or female ≥18 years old
Patients who are characterized by the following clinical features:
The same eye (study eye) must fulfill all the above criteria
Best corrected distance visual acuity (BCDVA) score of ≥ 0.1 decimal units in both eyes at the time of study enrolment
Female patients must have negative pregnancy urine test if at childbirth potential.

Key exclusion criteria (13 listed)

Any ocular disease other than Dry Eye requiring treatment with topical medications in either eye at the time of study enrolment.
Any active ocular infection or active inflammation in either eye unrelated to Dry Eye.
Presence or history of any systemic or ocular disorder, condition or disease (with particular attention to malignancies and neuro-oncological diseases) that could possibly interfere with the conduct of the required study procedures or the interpretation of the study results.
Use of therapeutic or Refractive Contact lenses in either eye at the time of study enrolment;
History of ocular surgery in the study eye(s), excluding corneal refractive or cataract procedures, within 90 days of study enrolment.

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
rhNGFAlso: NGFEye Drop 20 μg/mL	Drug	rhNGF 20 µg/ml
VehicleVehicle Eye Drop	Other	Vehicle

Primary outcome

Change From Baseline in SANDE Scores for Frequency and Severity Assessed at 8 Weeks of Treatment.
Time frame: Baseline and Week 8
The Symptom Assessment in Dry Eye (SANDE) questionnaire is a short questionnaire to evaluate both dry eye intensity and frequency by using a 100 mm visual analogue scale (VAS). The patient symptoms of ocular dryness and/or irritation were quantified on the scale based on two questions that assessed both the severity and frequency of symptoms. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
Changes in Cornea Vital Staining With Fluorescein (National Eye Institute [NEI] Scales)
Time frame: Baseline and Week 8
Corneal Staining was derived as the sum of scores of the five corneal sectors (central, superior, inferior, nasal, and temporal) each of which was scored on a scale of 0-3, with a minimum score of 0 and a maximal score of 15 (sum > 3 out of 15 is abnormal).

4 secondary outcomes

Changes in Conjunctiva Vital Staining With Fluorescein (National Eye Institute [NEI] Scales)
Time frame: From baseline to weeks 4, 8 and 12
Changes in Tear Film Break-Up Time (TFBUT)
Time frame: From baseline to weeks 4, 8 and 12
Changes in Cochet-Bonnet Corneal Aesthesiometry
Time frame: From baseline to week 8
Changes in SANDE Scores (Face Values) for Frequency and Severity
Time frame: From baseline to weeks 4, 8 and 12

Results and safety

Results posted to the registry on 22 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
rhNGF 20 µg/ml	120	116
Vehicle	60	59

Primary outcome: Change From Baseline in SANDE Scores for Frequency and Severity Assessed at 8 Weeks of Treatment.

Time frame: Baseline and Week 8. Mean (Standard Deviation). Unit: score on a scale

Measure	rhNGF 20 µg/ml n = 112	Vehicle n = 58
Frequency	-37.2 (24.85)	-35.7 (26.04)
Severity	-37.8 (27.20)	-37.3 (20.43)

rhNGF 20 µg/ml vs Vehicle: difference in LS means: -0.11 (95% CI -6.85 to 6.63), p =0.974, ANCOVA
rhNGF 20 µg/ml vs Vehicle: Difference in least square means: 2.88 (95% CI -3.85 to 9.61), p =0.399, ANCOVA

Population analysed: Full Analysis Set Population. Last observation carried forward (LOCF) imputation method

Primary outcome: Changes in Cornea Vital Staining With Fluorescein (National Eye Institute [NEI] Scales)

Time frame: Baseline and Week 8. Mean (Standard Deviation). Unit: score on a scale

Measure	rhNGF 20 µg/ml n = 112	Vehicle n = 58
Value	-2.5 (2.11)	-2.2 (1.81)

rhNGF 20 µg/ml vs Vehicle: difference in least square means: 0.04 (95% CI -0.02 to 0.10), p =0.214, ANCOVA

Population analysed: Full Analysis Set population. Last observation carried forward (LOCF) imputation method.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit). Other adverse events reported at 0.9% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
rhNGF 20 µg/ml	1 of 115 (0.9%)	50 of 115 (43.5%)	0 of 115
Vehicle	0 of 59 (0%)	19 of 59 (32.2%)	0 of 59

Limitations and caveats (from the sponsor): LImitations and caveats non specified

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Ocular Discomfort

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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.

Leonardo Mastropasqua, MD principal investigator

Univ. G. D'Annunzio- Clinica Oftalmologica Chieti

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 rhNGF in people with Ocular Discomfort, run by Dompé Farmaceutici S.p.A at 1 site in Italy.

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 9 inclusion and 13 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: finished, as of the sponsor's last update on 19 Apr 2024. 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 Italy. 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?

Yes. Results are posted in the registry (first posted 22 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in SANDE Scores for Frequency and Severity Assessed at 8 Weeks of Treatment. (time frame: Baseline and Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03035864.

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 19 Apr 2024.