Corneal Ulcer, Keratitis, Neurotrophic Keratitis
Conditions
Keywords
Keratitis, Corneal Ulcer
Brief summary
This study is aimed at assessing the safety and the efficacy of two dose regimens of recombinant human nerve growth factor (rhNGF) eye drops solution compared to vehicle for inducing a complete healing of stage 2 (persistent epithelial defect) and 3 (corneal ulcer) neurotrophic keratitis
Detailed description
The primary objective of this study is to assess the safety and the efficacy of two dose regimens (10 µg/ml or 20 µg/ml 6 times a day) of recombinant human nerve growth factor (rhNGF) eye drops solution compared to vehicle for inducing a complete healing of stage 2 (persistent epithelial defect) and 3 (corneal ulcer) neurotrophic keratitis (NK) as measured by the Reading Center evaluating the clinical pictures of corneal fluorescein staining. Secondary objectives of the study are to assess the duration of complete healing, improvement in visual acuity and improvement in corneal sensitivity following treatment with rhNGF eye drops solution This is a combined phase I/II study. The phase I and II segments of the study will be conducted as an 8 week, randomized, double-masked, vehicle controlled, parallel group study (referred to as the controlled treatment period) followed by a 48 or 56 week follow-up period The design of the phase I and phase II segments of the study are identical with the exception that in the phase I segment of the study the randomization scheme is different and patients will be followed with additional safety assessments and blood samples for PK (pharmacokinetic) profiling In the ascending dose Phase I segment of the study two doses of rhNGF 10 and 20 µg/ml will be evaluated in a sequential manner
Interventions
DRUGrhNGF 10 μg/ml
rhNGF 10 μg/ml : one drop 6 times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
DRUGrhNGF 20 μg/ml
one drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
OTHERvehicle
ophthalmic solution of the same composition as the test product without rhNGF
Sponsors
Dompé Farmaceutici S.p.A
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients 18 years of age or older. 2. Patients with stage 2 (persistent epithelial defect, PED) or stage 3 (corneal ulcer) neurotrophic keratitis involving only one eye. . Patients with Controlateral eye affected with stage 1 NK can be enrolled. 3. PED or corneal ulceration of at least 2 weeks duration refractory to one or more conventional non-surgical treatments for neurotrophic keratitis (e.g., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops and medications that can decrease corneal sensitivity; therapeutic contact lenses). 4. Evidence of decreased corneal sensitivity (≤ 4 cm using the Cochet-Bonnet aesthesiometer) within the area of the PED or corneal ulcer and outside of the area of the defect in at least one corneal quadrant. 5. Best corrected distance visual acuity (BCDVA) score ≤ 75 ETDRS letters, (≥ 0.2 LogMAR, ≤ 20/32 Snellen or ≤ 0.625 decimal fraction) in the affected eye. 6. No objective clinical evidence of improvement in the PED or corneal ulceration within the 2 weeks prior to study enrolment. 7. Only patients who satisfy all Informed Consent requirements may be included in the study. The patient and/or his/her legal representative must read, sign and date the Informed Consent document before any study-related procedures are performed. The Informed Consent form signed by patients and/or legal representative must have been approved by the IEC/IRB for the current study. 8. Patients must have the ability and willingness to comply with study procedures. 9. Patients must be eligible for the National Health Insurance (where applicable).
Exclusion criteria
1. Patients with stage 2 or 3 NK affecting both eyes. 2. Any active ocular infection (bacterial, viral, fungal or protozoal) or active ocular inflammation not related to NK in the affected eye. 3. Any other ocular disease requiring topical ocular treatment in the affected eye during the course of the study treatment period. No topical treatments other than the study medications provided by the study sponsor or allowed by the study protocol can be administered in the affected eye during the course of the study treatment periods. 4. Patients with severe vision loss in the affected eye with no potential for visual improvement in the opinion of the investigator as a result of the study treatment. 5. Schirmer test without anesthesia ≤3 mm/5 minutes in the affected eye. 6. Patients with severe blepharitis and/or severe meibomian gland disease in the affected eye. 7. History of any ocular surgery (including laser or refractive surgical procedures) in the affected eye within the three months before study enrolment. (An exception to the preceding statement will be allowed if the ocular surgery is considered to be the cause of the stage 2 or 3 NK). Ocular surgery in the affected eye will not be allowed during the study treatment period and elective ocular surgery procedures should not be planned during the duration of the follow-up period. 8. Prior surgical procedure(s) for the treatment of NK (e.g. complete tarsorraphy, conjunctival flap, etc) in the affected eye with the exception of amniotic membrane transplantation. Patients previously treated with amniotic membrane transplantation may only be enrolled two weeks after the membrane has disappeared within the area of the PED or corneal ulcer or at least six weeks after the date of the amniotic membrane transplantation procedure. Patients previously treated with Botox (botulinum toxin) injections used to induce pharmacologic blepharoptosis are eligible for enrolment only if the last injection was given at least 90 days prior to enrolment in the study. 9. Use of therapeutic contact lenses or contact lens wear for refractive correction during the study treatment periods in the eye with NK. 10. Anticipated need for punctual occlusion during the study treatment period. Patients with punctual occlusion or punctual plugs inserted prior to the study are eligible for enrolment provided that the punctual occlusion is maintained during the study. 11. Evidence of corneal ulceration involving the posterior third of the corneal stroma, corneal melting or perforation in the affected eye. 12. Presence or history of any ocular or systemic disorder or condition that might hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct (e.g. progressive or degenerative corneal or retinal conditions, uveitis, optic neuritis, poorly controlled diabetes, autoimmune disease, systemic infection, neoplastic diseases). 13. Any need for or anticipated change in the dose of systemic medications known to impair the function of the trigeminal nerve (e.g. neuroleptics, antipsychotic and antihistamine drugs). These treatments are allowed during the study if initiated prior to 30 days before study enrolment provided they remain stable throughout the course of the study treatment periods. 14. Known hypersensitivity to one of the components of the study or procedural medications (e.g. fluorescein). 15. History of drug, medication or alcohol abuse or addiction. 16. Use of any investigational agent within 4 weeks of screening visit. 17. Participation in another clinical study at the same time as the present study. 18. 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: are currently pregnant or have a positive result on the urine pregnancy test at the Randomization Visit or intend to become pregnant during the study treatment period or are breast-feeding or 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 during the entire course of and 30 days after the study treatment periods.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Achieving Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | at 4 weeks of treatment | Complete healing of the PED or corneal ulcer was determined by corneal fluorescein staining at 4 weeks as defined by the reading center evaluating the clinical pictures. Complete healing was defined as the greatest diameter of the corneal fluorescein staining in the area of the PED or corneal ulcer being less than 0.5 mm at the Week 4 visit. The primary efficacy variable was analyzed after 4 weeks of treatment only for the Phase II segment of the study. That's why the Phase I groups/arms are not included in this analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Experiencing Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | at 4 weeks of study treatment. | Complete healing of the PED or corneal ulcer at 4 weeks as defined by the Investigator. The complete healing was defined as the greatest diameter of the corneal fluorescein staining in the area of the PED or corneal ulcer, being less than 0.5 mm at the Week 4 visit. This secondary outcome was analyzed after 4 weeks of treatment only for the Phase II segment of the study. That's why the Phase I groups/arms are not included in this analysis. |
| Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | at 6 and 8 weeks after start of the treatment | Complete healing of the PED or corneal ulcer at 6 and 8 weeks measured by both the central reading center and Investigator. Complete healing was defined as the greatest diameter of the corneal fluorescein staining in the area of the PED or corneal ulcer being less than 0.5 mm. This outcome was analyzed after 6 and 8 weeks of treatment only for the Phase II segment of the study. That's why the Phase I groups/arms are not included in this analysis. |
| Percentage of Patients Experiencing Complete Corneal Clearing | at 4, 6 and 8 weeks after start of the treatment | Complete corneal clearing (grade 0 on the modified Oxford scale) at 4, 6 and 8 weeks. A patient was considered to have achieved complete corneal clearing if he/she had a Modified Oxford Scale recorded as Grade 0. The scale has the following grades: 0-1-2-3-4-5, where 5 represents the worst outcome value and 0 the best outcome value. |
| Mean Change in Best Corrected Distance Visual Acuity (BCDVA) | At screening and at week 8 | Mean changes in Best-Corrected Distance Visual Acuity (BCDVA) from baseline to Week 8 are calculated as Least Square means. BCDVA consists of letters read at 4 meters only. Patients are scored by how many letters could be correctly identified. Therefore the higher the number of letters, the higher the visual acuity. |
| Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | at 4, 6 and 8 weeks. | Percentage of patients that achieve an improvement in corneal sensitivity as measured by the Cochet-Bonnet aesthesiometer |
| Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | from baseline to Week 4, 6, and 8. | Percentage of patients experiencing deterioration (increase in lesion size ≥ 1mm, decrease in BCDVA by \>5 ETDRS letters, progression in lesion depth to corneal melting or perforation, onset of infection) in stage 2 or 3 NK from baseline to Week 4, 6, and 8. |
| Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | at week 4 and 8 | Global evaluation of efficacy as assessed by the Investigator at 4 and 8 weeks. The different level of efficacy were: very good; good; moderate; poor; non-evaluable. |
| Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | at baseline and at weeks 8 and 20 | Ocular tolerability was recorded by the patient on a VAS scale from 0 to 100 mm, where a higher VAS score indicates worse ocular symptoms (0 means no symptoms and 100 means the worst possible discomfort). The overall VAS score for ocular tolerability was calculated as the mean of the individual VAS scores for the 7 different symptoms (foreign body sensation, burning/stinging, itching, ocular pain, sticky feeling, blurred vision and photophobia). Results are below reported as per symptoms at week 8 (for treatment period) and week 20 (for Follow Up period). |
| Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | at baseline and at period 1 (8 weeks) and 2 (Follow Up period of 12 weeks, until week 20) | Best-Corrected Distance Visual Acuity (BCDVA) by means of the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart at 4 meters (13 feet). Data reported refers to week n° 8 (treatment group) and n°12/20 (FU group). |
| Change From Baseline in Intraocular Pressure (IOP) | Baseline, period 1 (8 weeks) and 2 (Follow Up period of 12 weeks, until week 20). | IOP was measured using a Goldmann applanation tonometer, a handheld applanation tonometer \[eg, Tonopen\], or other tonometer, after the instillation of a topical anesthetic. |
| Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | At week 8 (Phase 1 and Phase 2) | Dilated fundus ophthalmoscopy was performed to assess the vitreous, retina, macula, choroid and optic nerve head after dilation of the pupil. Percentage of patients is summarized for each eye structure by treatment and visit for the controlled treatment period for Phase I and Phase II separately. The assessment time points were Baseline, weeks 2, 4 and 8 for Phase 1; Baseline and week 8 for Phase 2; and weeks 12 and 56 for follow up. Only results for eye structure at week 8 are reported. |
| Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | at week 20/28, 32/40, 44/52, and 56/64 | Percentage of patients achieving complete healing of the PED or corneal ulcer by Week 8/16 that remain healed (ie, no recurrence of the PED and/or corneal ulcer) at Weeks 20/28, 32/40, 44/52, 56/64 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | at 4, 6 and 8 weeks | Percentage of patients that achieved a ≥15 letter gain in best corrected distance visual acuity (BCDVA) at 4, 6, and 8 weeks |
Countries
France, Germany, Italy, Poland, Spain, United Kingdom
Participant flow
Recruitment details
The study consisted of 2 periods: 8week PhaseI/controlled treatment period and 48/56-week FU period. In the Phase1 patients were randomized into 2 cohorts (of 9 pts each). In phase 2 pts were randomized in a 1:1:1 ratio (52 pts each group). Data refer to the 1st database lock when the last patient in Phase2 had completed 12 weeks of FU period.
Pre-assignment details
The inclusion/exclusion criteria were designed to include individuals 18 years of age or older with Stage 2 (PED) or Stage 3 (corneal ulcer) NK involving only 1 eye and to exclude those with Stage 2 or 3 NK affecting both eyes, any active ocular infection or inflammation not related to NK, or any ocular disease or severe vision loss.
Participants by arm
| Arm | Count |
|---|---|
| 1_rhNGF10_Phase 1_treatment rhNGF 10 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only | 7 |
| 2_rhNGF20_Phase 1_treatment rhNGF 20 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only | 7 |
| 3_vehicle group_Phase 1_treatment Placebo eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only | 4 |
| 4_rhNGF10_Phase 2_treatment rhNGF 10 µg/ml eye drops solution: rhNGF 10 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only | 52 |
| 5_rhNGF20_Phase 2_treatment rhNGF 20 µg/ml eye drops solution: rhNGF 20 µg/ml eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only | 52 |
| 6_vehicle group_Phase 2_treatment Placebo: Placebo eye drops solution, one drop 6 times a day for 8 weeks in the affected eye only. | 52 |
| Total | 174 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Follow Up Period Phase I/II | Adverse Event | 1 | 0 | 0 | 5 | 0 | 1 |
| Follow Up Period Phase I/II | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 1 |
| Follow Up Period Phase I/II | Lost to Follow-up | 0 | 0 | 1 | 2 | 0 | 1 |
| Follow Up Period Phase I/II | Other causes | 0 | 0 | 0 | 1 | 3 | 5 |
| Follow Up Period Phase I/II | parent withdrew the consent to continue | 0 | 1 | 0 | 0 | 0 | 0 |
| Follow Up Period Phase I/II | still in study after week 20 | 0 | 0 | 0 | 25 | 23 | 25 |
| Treatment Period: Phase I/II | Adverse Event | 1 | 0 | 2 | 3 | 9 | 1 |
| Treatment Period: Phase I/II | decision unrelated to adverse event | 0 | 0 | 0 | 1 | 1 | 1 |
| Treatment Period: Phase I/II | Lack of Efficacy | 0 | 0 | 0 | 2 | 1 | 0 |
| Treatment Period: Phase I/II | Other causes | 0 | 0 | 0 | 1 | 2 | 2 |
| Treatment Period: Phase I/II | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 1_rhNGF10_Phase 1_treatment | 2_rhNGF20_Phase 1_treatment | 3_vehicle group_Phase 1_treatment | 4_rhNGF10_Phase 2_treatment | 5_rhNGF20_Phase 2_treatment | 6_vehicle group_Phase 2_treatment | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous Age continuous | 61.7 years STANDARD_DEVIATION 21.47 | 52.0 years STANDARD_DEVIATION 17.24 | 64.3 years STANDARD_DEVIATION 24.06 | 59.0 years STANDARD_DEVIATION 17.17 | 62.5 years STANDARD_DEVIATION 14.01 | 60.4 years STANDARD_DEVIATION 16.78 | 58.5 years STANDARD_DEVIATION 19.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 6 Participants | 9 Participants | 5 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 6 Participants | 4 Participants | 42 Participants | 42 Participants | 41 Participants | 141 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 4 Participants | 1 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 2 Participants | 30 Participants | 30 Participants | 35 Participants | 104 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 2 Participants | 22 Participants | 22 Participants | 17 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 | 0 / 4 | 5 / 52 | 2 / 52 | 1 / 52 |
| other Total, other adverse events | 3 / 7 | 5 / 7 | 1 / 4 | 23 / 52 | 23 / 52 | 21 / 52 |
| serious Total, serious adverse events | 3 / 7 | 1 / 7 | 3 / 4 | 13 / 52 | 14 / 52 | 4 / 52 |
Outcome results
Primary
Percentage of Patients Achieving Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer
Complete healing of the PED or corneal ulcer was determined by corneal fluorescein staining at 4 weeks as defined by the reading center evaluating the clinical pictures. Complete healing was defined as the greatest diameter of the corneal fluorescein staining in the area of the PED or corneal ulcer being less than 0.5 mm at the Week 4 visit. The primary efficacy variable was analyzed after 4 weeks of treatment only for the Phase II segment of the study. That's why the Phase I groups/arms are not included in this analysis.
Time frame: at 4 weeks of treatment
Population: Phase II patients who achieved complete healing at Week 4 (last observation carried forward - LOCF) as determined by the reading center (ITT population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Achieving Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | Yes | 55 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Achieving Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | No | 45 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Achieving Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | Yes | 58 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Achieving Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | No | 42 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Achieving Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | Yes | 20 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Achieving Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | No | 80 percentage of subjects |
Comparison: Phase IIp-value: <0.00197.06% CI: [15.88, 54.71]Chi-squared
p-value: =0.00197.06% CI: [18.96, 57.83]Chi-squared
Secondary
Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA)
Best-Corrected Distance Visual Acuity (BCDVA) by means of the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart at 4 meters (13 feet). Data reported refers to week n° 8 (treatment group) and n°12/20 (FU group).
Time frame: at baseline and at period 1 (8 weeks) and 2 (Follow Up period of 12 weeks, until week 20)
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Baseline | 42 Number of ETDRS letters | Standard Deviation 28.25 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Change from baseline | 9.3 Number of ETDRS letters | Standard Deviation 5.89 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Baseline | 30.4 Number of ETDRS letters | Standard Deviation 24.85 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Change from baseline | 8.7 Number of ETDRS letters | Standard Deviation 12.41 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Baseline | 9.5 Number of ETDRS letters | Standard Deviation 11.96 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Change from baseline | -1 Number of ETDRS letters | Standard Deviation 1.41 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Baseline | 30.7 Number of ETDRS letters | Standard Deviation 28.35 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Change from baseline | 15.8 Number of ETDRS letters | Standard Deviation 16.82 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Change from baseline | 11.9 Number of ETDRS letters | Standard Deviation 20.9 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Baseline | 24.2 Number of ETDRS letters | Standard Deviation 25.88 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Baseline | 32.4 Number of ETDRS letters | Standard Deviation 26.07 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Change from baseline | 6.9 Number of ETDRS letters | Standard Deviation 15.44 |
| 1_rhNGF10_Phase 1_FU | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Change from baseline | 11.2 Number of ETDRS letters | Standard Deviation 7.47 |
| 1_rhNGF10_Phase 1_FU | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Baseline | 42 Number of ETDRS letters | Standard Deviation 28.25 |
| 2_rhNGF20_Phase 1_FU | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Baseline | 30.4 Number of ETDRS letters | Standard Deviation 24.85 |
| 2_rhNGF20_Phase 1_FU | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Change from baseline | 7 Number of ETDRS letters | Standard Deviation 9.8 |
| 3_vehicle group_Phase 1_FU | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Baseline | 9.5 Number of ETDRS letters | Standard Deviation 11.96 |
| 3_vehicle group_Phase 1_FU | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Change from baseline | -6 Number of ETDRS letters | Standard Deviation 0 |
| 4_rhNGF10_Phase 2_FU | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Baseline | 30.7 Number of ETDRS letters | Standard Deviation 28.35 |
| 4_rhNGF10_Phase 2_FU | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Change from baseline | 13.2 Number of ETDRS letters | Standard Deviation 16.8 |
| 5_rhNGF20_Phase 2_FU | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Change from baseline | 14.2 Number of ETDRS letters | Standard Deviation 19.6 |
| 5_rhNGF20_Phase 2_FU | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Baseline | 24.2 Number of ETDRS letters | Standard Deviation 25.88 |
| 6_vehicle_Phase 2_FU | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Change from baseline | 8.8 Number of ETDRS letters | Standard Deviation 14.27 |
| 6_vehicle_Phase 2_FU | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) | Baseline | 32.4 Number of ETDRS letters | Standard Deviation 26.07 |
Secondary
Change From Baseline in Intraocular Pressure (IOP)
IOP was measured using a Goldmann applanation tonometer, a handheld applanation tonometer \[eg, Tonopen\], or other tonometer, after the instillation of a topical anesthetic.
Time frame: Baseline, period 1 (8 weeks) and 2 (Follow Up period of 12 weeks, until week 20).
Population: safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Intraocular Pressure (IOP) | Baseline | 16.1 mmHg | Standard Deviation 3.85 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Intraocular Pressure (IOP) | Change from baseline | -1.8 mmHg | Standard Deviation 2.48 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Intraocular Pressure (IOP) | Baseline | 11.3 mmHg | Standard Deviation 3.68 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Intraocular Pressure (IOP) | Change from baseline | 1.9 mmHg | Standard Deviation 5.24 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Intraocular Pressure (IOP) | Baseline | 11.8 mmHg | Standard Deviation 3.3 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Intraocular Pressure (IOP) | Change from baseline | 3.5 mmHg | Standard Deviation 2.12 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Intraocular Pressure (IOP) | Baseline | 14.3 mmHg | Standard Deviation 3.16 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Intraocular Pressure (IOP) | Change from baseline | -0.1 mmHg | Standard Deviation 3.71 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Intraocular Pressure (IOP) | Change from baseline | 0.9 mmHg | Standard Deviation 2.61 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Intraocular Pressure (IOP) | Baseline | 14 mmHg | Standard Deviation 3.06 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Intraocular Pressure (IOP) | Baseline | 14.1 mmHg | Standard Deviation 3.16 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Intraocular Pressure (IOP) | Change from baseline | 0.8 mmHg | Standard Deviation 3.43 |
| 1_rhNGF10_Phase 1_FU | Change From Baseline in Intraocular Pressure (IOP) | Change from baseline | -2.2 mmHg | Standard Deviation 2.49 |
| 1_rhNGF10_Phase 1_FU | Change From Baseline in Intraocular Pressure (IOP) | Baseline | 16.1 mmHg | Standard Deviation 3.85 |
| 2_rhNGF20_Phase 1_FU | Change From Baseline in Intraocular Pressure (IOP) | Baseline | 11.3 mmHg | Standard Deviation 3.68 |
| 2_rhNGF20_Phase 1_FU | Change From Baseline in Intraocular Pressure (IOP) | Change from baseline | 2.3 mmHg | Standard Deviation 3.78 |
| 3_vehicle group_Phase 1_FU | Change From Baseline in Intraocular Pressure (IOP) | Baseline | 11.8 mmHg | Standard Deviation 3.3 |
| 3_vehicle group_Phase 1_FU | Change From Baseline in Intraocular Pressure (IOP) | Change from baseline | -3 mmHg | Standard Deviation 0 |
| 4_rhNGF10_Phase 2_FU | Change From Baseline in Intraocular Pressure (IOP) | Baseline | 14.3 mmHg | Standard Deviation 3.16 |
| 4_rhNGF10_Phase 2_FU | Change From Baseline in Intraocular Pressure (IOP) | Change from baseline | 0.2 mmHg | Standard Deviation 3.25 |
| 5_rhNGF20_Phase 2_FU | Change From Baseline in Intraocular Pressure (IOP) | Change from baseline | 0.1 mmHg | Standard Deviation 3.64 |
| 5_rhNGF20_Phase 2_FU | Change From Baseline in Intraocular Pressure (IOP) | Baseline | 14 mmHg | Standard Deviation 3.06 |
| 6_vehicle_Phase 2_FU | Change From Baseline in Intraocular Pressure (IOP) | Change from baseline | 0.6 mmHg | Standard Deviation 3.93 |
| 6_vehicle_Phase 2_FU | Change From Baseline in Intraocular Pressure (IOP) | Baseline | 14.1 mmHg | Standard Deviation 3.16 |
Secondary
Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability
Ocular tolerability was recorded by the patient on a VAS scale from 0 to 100 mm, where a higher VAS score indicates worse ocular symptoms (0 means no symptoms and 100 means the worst possible discomfort). The overall VAS score for ocular tolerability was calculated as the mean of the individual VAS scores for the 7 different symptoms (foreign body sensation, burning/stinging, itching, ocular pain, sticky feeling, blurred vision and photophobia). Results are below reported as per symptoms at week 8 (for treatment period) and week 20 (for Follow Up period).
Time frame: at baseline and at weeks 8 and 20
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_baseline | 71 VAS score | Standard Deviation 38.37 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_CFB | -25.7 VAS score | Standard Deviation 34.37 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_Baseline | 50.4 VAS score | Standard Deviation 25.68 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_CFB | -14.7 VAS score | Standard Deviation 38.02 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_CFB | -3 VAS score | Standard Deviation 17.93 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_CFB | -19.5 VAS score | Standard Deviation 27.98 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_CFB | -21.2 VAS score | Standard Deviation 25.96 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_baseline | 34.1 VAS score | Standard Deviation 36.96 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_CFB | -7.2 VAS score | Standard Deviation 42.82 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_CFB | -21.2 VAS score | Standard Deviation 28.96 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_baseline | 64.7 VAS score | Standard Deviation 42.9 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_baseline | 17 VAS score | Standard Deviation 27.4 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_baseline | 41.4 VAS score | Standard Deviation 30.85 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_baseline | 47.6 VAS score | Standard Deviation 34.14 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_baseline | 85.7 VAS score | Standard Deviation 14.74 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_CFB | -12.1 VAS score | Standard Deviation 28.27 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_CFB | -10 VAS score | Standard Deviation 23.1 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_CFB | -25 VAS score | Standard Deviation 32.15 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_baseline | 18.7 VAS score | Standard Deviation 19.62 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_CFB | -18.7 VAS score | Standard Deviation 38.32 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_baseline | 33.6 VAS score | Standard Deviation 34.73 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_Baseline | 24 VAS score | Standard Deviation 19.76 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_CFB | -6 VAS score | Standard Deviation 30.72 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_CFB | -20.7 VAS score | Standard Deviation 34.13 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_baseline | 30.7 VAS score | Standard Deviation 38.78 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_baseline | 32.1 VAS score | Standard Deviation 35.34 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_baseline | 66.6 VAS score | Standard Deviation 29.85 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_CFB | -12.9 VAS score | Standard Deviation 17.03 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_CFB | -30.5 VAS score | Standard Deviation 43.13 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_baseline | 19 VAS score | Standard Deviation 38 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_CFB | -16 VAS score | Standard Deviation 65.05 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_Baseline | 20.5 VAS score | Standard Deviation 29.23 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_baseline | 30.3 VAS score | Standard Deviation 26.21 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_baseline | 18 VAS score | Standard Deviation 28.57 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_CFB | -22 VAS score | Standard Deviation 31.11 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_CFB | -28.5 VAS score | Standard Deviation 23.33 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_baseline | 93.5 VAS score | Standard Deviation 7.9 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_CFB | -11 VAS score | Standard Deviation 5.66 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_baseline | 7.8 VAS score | Standard Deviation 15.5 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_baseline | 15.5 VAS score | Standard Deviation 23.69 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_CFB | -15.5 VAS score | Standard Deviation 21.92 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_CFB | -23 VAS score | Standard Deviation 32.53 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_CFB | -11.7 VAS score | Standard Deviation 30.17 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_baseline | 26.6 VAS score | Standard Deviation 29.65 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_baseline | 32.8 VAS score | Standard Deviation 34.86 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_baseline | 24.1 VAS score | Standard Deviation 27.48 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_CFB | -17.8 VAS score | Standard Deviation 41.23 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_baseline | 32.5 VAS score | Standard Deviation 32.88 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_CFB | -2 VAS score | Standard Deviation 43 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_baseline | 80.2 VAS score | Standard Deviation 25.18 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_baseline | 64.3 VAS score | Standard Deviation 32.07 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_Baseline | 34.8 VAS score | Standard Deviation 29.4 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_CFB | -10.8 VAS score | Standard Deviation 29.25 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_CFB | -3.8 VAS score | Standard Deviation 42.13 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_CFB | -24.9 VAS score | Standard Deviation 35.33 |
| 4_rhNGF10_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_CFB | -8.8 VAS score | Standard Deviation 34.68 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_Baseline | 35.4 VAS score | Standard Deviation 34.79 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_baseline | 26.5 VAS score | Standard Deviation 30.86 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_CFB | -4.3 VAS score | Standard Deviation 29.55 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_CFB | -13.2 VAS score | Standard Deviation 40.44 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_CFB | -26.2 VAS score | Standard Deviation 31.58 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_baseline | 21.8 VAS score | Standard Deviation 28.68 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_CFB | -16.5 VAS score | Standard Deviation 36.87 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_baseline | 17.4 VAS score | Standard Deviation 22.07 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_CFB | 2 VAS score | Standard Deviation 37.25 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_baseline | 57.6 VAS score | Standard Deviation 36.1 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_baseline | 21.1 VAS score | Standard Deviation 28.38 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_baseline | 83.2 VAS score | Standard Deviation 24.45 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_CFB | -2.5 VAS score | Standard Deviation 26.76 |
| 5_rhNGF20_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_CFB | -7.3 VAS score | Standard Deviation 22.67 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_baseline | 78.5 VAS score | Standard Deviation 24.68 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_Baseline | 37.7 VAS score | Standard Deviation 36.49 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_CFB | -20.9 VAS score | Standard Deviation 35.86 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_baseline | 30.2 VAS score | Standard Deviation 32.21 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_CFB | -18 VAS score | Standard Deviation 32.97 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_baseline | 22.9 VAS score | Standard Deviation 28.43 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_CFB | -8.9 VAS score | Standard Deviation 25.59 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_baseline | 28.8 VAS score | Standard Deviation 32.82 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_CFB | -16.3 VAS score | Standard Deviation 30.52 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_baseline | 26.1 VAS score | Standard Deviation 31.93 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_CFB | -10.7 VAS score | Standard Deviation 29.95 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_CFB | -17.4 VAS score | Standard Deviation 28.55 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_baseline | 65.2 VAS score | Standard Deviation 34.71 |
| 6_vehicle group_Phase 2_treatment | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_CFB | -17.5 VAS score | Standard Deviation 29.02 |
| 1_rhNGF10_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_CFB | -26.5 VAS score | Standard Deviation 31.18 |
| 1_rhNGF10_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_CFB | -19.8 VAS score | Standard Deviation 22.18 |
| 1_rhNGF10_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_CFB | -20.3 VAS score | Standard Deviation 28.63 |
| 1_rhNGF10_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_CFB | -16 VAS score | Standard Deviation 28.59 |
| 1_rhNGF10_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_baseline | 47.6 VAS score | Standard Deviation 34.14 |
| 1_rhNGF10_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_CFB | -20 VAS score | Standard Deviation 30.32 |
| 1_rhNGF10_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_baseline | 64.7 VAS score | Standard Deviation 42.9 |
| 1_rhNGF10_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_baseline | 41.4 VAS score | Standard Deviation 30.85 |
| 1_rhNGF10_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_baseline | 17 VAS score | Standard Deviation 27.4 |
| 1_rhNGF10_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_baseline | 71 VAS score | Standard Deviation 38.37 |
| 1_rhNGF10_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_CFB | -18 VAS score | Standard Deviation 41.65 |
| 1_rhNGF10_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_baseline | 34.1 VAS score | Standard Deviation 36.96 |
| 1_rhNGF10_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_CFB | -7.8 VAS score | Standard Deviation 27.18 |
| 1_rhNGF10_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_Baseline | 50.4 VAS score | Standard Deviation 25.68 |
| 2_rhNGF20_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_CFB | -0.7 VAS score | Standard Deviation 12.52 |
| 2_rhNGF20_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_baseline | 85.7 VAS score | Standard Deviation 14.74 |
| 2_rhNGF20_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_CFB | -26.2 VAS score | Standard Deviation 17.93 |
| 2_rhNGF20_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_baseline | 30.7 VAS score | Standard Deviation 38.78 |
| 2_rhNGF20_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_baseline | 33.6 VAS score | Standard Deviation 34.73 |
| 2_rhNGF20_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_Baseline | 24 VAS score | Standard Deviation 19.76 |
| 2_rhNGF20_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_CFB | -26 VAS score | Standard Deviation 39.88 |
| 2_rhNGF20_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_baseline | 32.1 VAS score | Standard Deviation 35.34 |
| 2_rhNGF20_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_CFB | -4.2 VAS score | Standard Deviation 28.51 |
| 2_rhNGF20_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_baseline | 18.7 VAS score | Standard Deviation 19.62 |
| 2_rhNGF20_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_baseline | 66.6 VAS score | Standard Deviation 29.85 |
| 2_rhNGF20_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_CFB | -13 VAS score | Standard Deviation 25.3 |
| 2_rhNGF20_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_CFB | -16.5 VAS score | Standard Deviation 17.13 |
| 2_rhNGF20_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_CFB | -9.3 VAS score | Standard Deviation 11.86 |
| 3_vehicle group_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_baseline | 7.8 VAS score | Standard Deviation 15.5 |
| 3_vehicle group_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_CFB | -61 VAS score | Standard Deviation 0 |
| 3_vehicle group_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_CFB | -31 VAS score | Standard Deviation 0 |
| 3_vehicle group_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_baseline | 19 VAS score | Standard Deviation 38 |
| 3_vehicle group_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_CFB | -2 VAS score | Standard Deviation 0 |
| 3_vehicle group_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_baseline | 18 VAS score | Standard Deviation 28.57 |
| 3_vehicle group_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_CFB | -26 VAS score | Standard Deviation 0 |
| 3_vehicle group_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_CFB | -52 VAS score | Standard Deviation 0 |
| 3_vehicle group_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_CFB | -12 VAS score | Standard Deviation 0 |
| 3_vehicle group_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_baseline | 30.3 VAS score | Standard Deviation 26.21 |
| 3_vehicle group_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_CFB | -14 VAS score | Standard Deviation 0 |
| 3_vehicle group_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_Baseline | 20.5 VAS score | Standard Deviation 29.23 |
| 3_vehicle group_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_baseline | 93.5 VAS score | Standard Deviation 7.9 |
| 3_vehicle group_Phase 1_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_baseline | 15.5 VAS score | Standard Deviation 23.69 |
| 4_rhNGF10_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_Baseline | 34.8 VAS score | Standard Deviation 29.4 |
| 4_rhNGF10_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_CFB | -10.2 VAS score | Standard Deviation 30.62 |
| 4_rhNGF10_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_CFB | -16.7 VAS score | Standard Deviation 34.66 |
| 4_rhNGF10_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_baseline | 24.1 VAS score | Standard Deviation 27.48 |
| 4_rhNGF10_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_baseline | 26.6 VAS score | Standard Deviation 29.65 |
| 4_rhNGF10_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_CFB | -14.9 VAS score | Standard Deviation 40.35 |
| 4_rhNGF10_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_CFB | -13.3 VAS score | Standard Deviation 30.75 |
| 4_rhNGF10_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_baseline | 32.5 VAS score | Standard Deviation 32.88 |
| 4_rhNGF10_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_baseline | 80.2 VAS score | Standard Deviation 25.18 |
| 4_rhNGF10_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_CFB | -24.2 VAS score | Standard Deviation 37.51 |
| 4_rhNGF10_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_CFB | -16.5 VAS score | Standard Deviation 38.42 |
| 4_rhNGF10_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_CFB | -16.6 VAS score | Standard Deviation 31.26 |
| 4_rhNGF10_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_baseline | 64.3 VAS score | Standard Deviation 32.07 |
| 4_rhNGF10_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_baseline | 32.8 VAS score | Standard Deviation 34.86 |
| 5_rhNGF20_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_baseline | 83.2 VAS score | Standard Deviation 24.45 |
| 5_rhNGF20_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_CFB | -11.9 VAS score | Standard Deviation 23.05 |
| 5_rhNGF20_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_CFB | -25.7 VAS score | Standard Deviation 34.41 |
| 5_rhNGF20_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_CFB | -11.4 VAS score | Standard Deviation 31.11 |
| 5_rhNGF20_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_CFB | -21 VAS score | Standard Deviation 38.76 |
| 5_rhNGF20_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_CFB | -10.8 VAS score | Standard Deviation 31.51 |
| 5_rhNGF20_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_baseline | 21.1 VAS score | Standard Deviation 28.38 |
| 5_rhNGF20_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_baseline | 57.6 VAS score | Standard Deviation 36.1 |
| 5_rhNGF20_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_Baseline | 35.4 VAS score | Standard Deviation 34.79 |
| 5_rhNGF20_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_baseline | 17.4 VAS score | Standard Deviation 22.07 |
| 5_rhNGF20_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_baseline | 21.8 VAS score | Standard Deviation 28.68 |
| 5_rhNGF20_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_CFB | -22.4 VAS score | Standard Deviation 38.77 |
| 5_rhNGF20_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_CFB | -12.1 VAS score | Standard Deviation 31.25 |
| 5_rhNGF20_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_baseline | 26.5 VAS score | Standard Deviation 30.86 |
| 6_vehicle_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_CFB | -14.6 VAS score | Standard Deviation 29.19 |
| 6_vehicle_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | photophobia_baseline | 65.2 VAS score | Standard Deviation 34.71 |
| 6_vehicle_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_CFB | -18.3 VAS score | Standard Deviation 34.3 |
| 6_vehicle_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_CFB | -17.4 VAS score | Standard Deviation 27.14 |
| 6_vehicle_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | ocular pain_baseline | 28.8 VAS score | Standard Deviation 32.82 |
| 6_vehicle_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_baseline | 30.2 VAS score | Standard Deviation 32.21 |
| 6_vehicle_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_CFB | -8.3 VAS score | Standard Deviation 30.62 |
| 6_vehicle_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_CFB | -4.8 VAS score | Standard Deviation 30.71 |
| 6_vehicle_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_Baseline | 37.7 VAS score | Standard Deviation 36.49 |
| 6_vehicle_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | Foreign Body Sensation_CFB | -20.7 VAS score | Standard Deviation 30.57 |
| 6_vehicle_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | blurred vision_baseline | 78.5 VAS score | Standard Deviation 24.68 |
| 6_vehicle_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | burning/stinging_CFB | -14.7 VAS score | Standard Deviation 37.54 |
| 6_vehicle_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | sticky feeling_baseline | 26.1 VAS score | Standard Deviation 31.93 |
| 6_vehicle_Phase 2_FU | Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability | itching_baseline | 22.9 VAS score | Standard Deviation 28.43 |
Secondary
Mean Change in Best Corrected Distance Visual Acuity (BCDVA)
Mean changes in Best-Corrected Distance Visual Acuity (BCDVA) from baseline to Week 8 are calculated as Least Square means. BCDVA consists of letters read at 4 meters only. Patients are scored by how many letters could be correctly identified. Therefore the higher the number of letters, the higher the visual acuity.
Time frame: At screening and at week 8
Population: ITT population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 4_rhNGF10_Phase 2_treatment | Mean Change in Best Corrected Distance Visual Acuity (BCDVA) | 15.8 LogMAR | Standard Error 2.58 |
| 5_rhNGF20_Phase 2_treatment | Mean Change in Best Corrected Distance Visual Acuity (BCDVA) | 11.9 LogMAR | Standard Error 2.8 |
| 6_vehicle group_Phase 2_treatment | Mean Change in Best Corrected Distance Visual Acuity (BCDVA) | 6.9 LogMAR | Standard Error 2.83 |
p-value: =0.02295% CI: [1.33, 16.5]ANCOVA
p-value: =0.21395% CI: [-2.9, 12.88]ANCOVA
Secondary
Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy
Dilated fundus ophthalmoscopy was performed to assess the vitreous, retina, macula, choroid and optic nerve head after dilation of the pupil. Percentage of patients is summarized for each eye structure by treatment and visit for the controlled treatment period for Phase I and Phase II separately. The assessment time points were Baseline, weeks 2, 4 and 8 for Phase 1; Baseline and week 8 for Phase 2; and weeks 12 and 56 for follow up. Only results for eye structure at week 8 are reported.
Time frame: At week 8 (Phase 1 and Phase 2)
Population: safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4_rhNGF10_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Vitreous | 0 percentage of participants |
| 4_rhNGF10_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Retina macula | 25 percentage of participants |
| 4_rhNGF10_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Choroid | 0 percentage of participants |
| 4_rhNGF10_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Optic nerve | 25 percentage of participants |
| 5_rhNGF20_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Choroid | 25 percentage of participants |
| 5_rhNGF20_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Retina macula | 25 percentage of participants |
| 5_rhNGF20_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Vitreous | 0 percentage of participants |
| 5_rhNGF20_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Optic nerve | 0 percentage of participants |
| 6_vehicle group_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Optic nerve | 100 percentage of participants |
| 6_vehicle group_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Choroid | 0 percentage of participants |
| 6_vehicle group_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Retina macula | 100 percentage of participants |
| 6_vehicle group_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Vitreous | 0 percentage of participants |
| 4_rhNGF10_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Vitreous | 14.7 percentage of participants |
| 4_rhNGF10_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Optic nerve | 11.8 percentage of participants |
| 4_rhNGF10_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Retina macula | 17.6 percentage of participants |
| 4_rhNGF10_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Choroid | 8.8 percentage of participants |
| 5_rhNGF20_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Choroid | 6.5 percentage of participants |
| 5_rhNGF20_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Optic nerve | 12.5 percentage of participants |
| 5_rhNGF20_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Retina macula | 23.3 percentage of participants |
| 5_rhNGF20_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Vitreous | 18.2 percentage of participants |
| 6_vehicle group_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Retina macula | 28.6 percentage of participants |
| 6_vehicle group_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Choroid | 14.8 percentage of participants |
| 6_vehicle group_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Optic nerve | 7.7 percentage of participants |
| 6_vehicle group_Phase 2_treatment | Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy | Vitreous | 10.3 percentage of participants |
Secondary
Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64
Percentage of patients achieving complete healing of the PED or corneal ulcer by Week 8/16 that remain healed (ie, no recurrence of the PED and/or corneal ulcer) at Weeks 20/28, 32/40, 44/52, 56/64
Time frame: at week 20/28, 32/40, 44/52, and 56/64
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 32/40 - yes | 100 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 20/28 - no | 0 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 20/28 - yes | 100 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 32/40 - no | 0 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 44/52 - yes | 100 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 44/52 - no | 0 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 56/64 - yes | 100 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 56/64 - no | 0 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 32/40 - no | 25 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 56/64 - no | 20 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 20/28 - yes | 75 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 56/64 - yes | 80 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 44/52 - no | 20 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 32/40 - yes | 75 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 20/28 - no | 25 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 44/52 - yes | 80 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 20/28 - no | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 32/40 - yes | 100 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 32/40 - no | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 56/64 - no | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 44/52 - yes | 100 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 44/52 - no | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 56/64 - yes | 100 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 20/28 - yes | 100 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 56/64 - yes | 67 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 44/52 - no | 33 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 44/52 - yes | 67 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 20/28 - yes | 87 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 32/40 - yes | 78 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 32/40 - no | 22 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 56/64 - no | 33 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 20/28 - no | 13 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 56/64 - no | 18 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 20/28 - yes | 89 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 44/52 - yes | 88 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 44/52 - no | 12 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 56/64 - yes | 82 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 20/28 - no | 11 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 32/40 - yes | 92 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 32/40 - no | 8 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 56/64 - no | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 44/52 - yes | 100 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 32/40 - yes | 100 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 32/40 - no | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 44/52 - no | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 20/28 - no | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 56/64 - yes | 100 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64 | week 20/28 - yes | 100 percentage of subjects |
Secondary
Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks
Global evaluation of efficacy as assessed by the Investigator at 4 and 8 weeks. The different level of efficacy were: very good; good; moderate; poor; non-evaluable.
Time frame: at week 4 and 8
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - poor | 33 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - very good | 17 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - very good | 17 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - non-evaluable | 0 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - non-evaluable | 0 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - poor | 17 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - good | 33 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - good | 33 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - moderate | 33 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - moderate | 17 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - good | 43 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - good | 43 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - very good | 29 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - non-evaluable | 0 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - poor | 29 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - moderate | 0 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - non-evaluable | 0 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - poor | 29 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - moderate | 0 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - very good | 29 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - good | 50 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - poor | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - good | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - non-evaluable | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - moderate | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - very good | 67 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - poor | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - non-evaluable | 33 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - moderate | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - very good | 50 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - moderate | 12 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - poor | 6 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - moderate | 15 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - good | 31 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - very good | 48 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - non-evaluable | 4 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - poor | 4 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - good | 38 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - non-evaluable | 2 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - very good | 40 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - poor | 10 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - very good | 34 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - good | 49 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - moderate | 7 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - poor | 10 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - non-evaluable | 0 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - very good | 40 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - good | 45 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - moderate | 5 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - non-evaluable | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - good | 20 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - very good | 40 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - non-evaluable | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - poor | 28 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - poor | 19 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - moderate | 21 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - good | 35 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 4 - very good | 26 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - non-evaluable | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks | week 8 - moderate | 12 percentage of subjects |
Comparison: week 4p-value: =0.04195% CI: [1.03, 4.62]Chi-squared
Comparison: week 4p-value: =0.08195% CI: [0.92, 4.11]Chi-squared
Comparison: week 8p-value: =0.0495% CI: [1.04, 5.88]Chi-squared
Comparison: week 8p-value: =0.13295% CI: [0.82, 4.52]Chi-squared
Secondary
Percentage of Patients Experiencing Complete Corneal Clearing
Complete corneal clearing (grade 0 on the modified Oxford scale) at 4, 6 and 8 weeks. A patient was considered to have achieved complete corneal clearing if he/she had a Modified Oxford Scale recorded as Grade 0. The scale has the following grades: 0-1-2-3-4-5, where 5 represents the worst outcome value and 0 the best outcome value.
Time frame: at 4, 6 and 8 weeks after start of the treatment
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 4 - yes | 0 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 4 - no | 100 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 6 - yes | 17 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 6 - no | 83 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 8 -yes | 17 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 8 - no | 83 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 4 - no | 83 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 6 - no | 86 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 8 - no | 86 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 4 - yes | 17 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 6 - yes | 14 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 8 -yes | 14 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 8 - no | 100 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 8 -yes | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 6 - no | 100 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 6 - yes | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 4 - yes | 33 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 4 - no | 67 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 6 - no | 76 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 4 - no | 79 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 6 - yes | 24 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 8 - no | 73 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 8 -yes | 27 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 4 - yes | 21 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 4 - yes | 20 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 8 -yes | 21 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 4 - no | 80 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 6 - yes | 23 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 6 - no | 77 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 8 - no | 79 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 6 - no | 92 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 6 - yes | 8 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 8 -yes | 10 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 8 - no | 90 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 4 - no | 93 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Complete Corneal Clearing | week 4 - yes | 7 percentage of subjects |
Comparison: week 4p-value: =0.06595% CI: [-0.19, 27.57]Chi-squared
Comparison: week 4p-value: =0.09795% CI: [-2.05, 26.78]Chi-squared
Comparison: week 6p-value: =0.03695% CI: [1.97, 31.92]Chi-squared
Comparison: week 6p-value: =0.05495% CI: [0.04, 31.12]Chi-squared
Comparison: week 8p-value: =0.04395% CI: [1.45, 32.72]Chi-squared
Comparison: week 8p-value: =0.15795% CI: [-4.08, 26.93]Chi-squared
Secondary
Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer
Complete healing of the PED or corneal ulcer at 6 and 8 weeks measured by both the central reading center and Investigator. Complete healing was defined as the greatest diameter of the corneal fluorescein staining in the area of the PED or corneal ulcer being less than 0.5 mm. This outcome was analyzed after 6 and 8 weeks of treatment only for the Phase II segment of the study. That's why the Phase I groups/arms are not included in this analysis.
Time frame: at 6 and 8 weeks after start of the treatment
Population: Phase II patients who achieved complete healing at Week 4 (last observation carried forward - LOCF) as determined by the reading center (ITT population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 6 - central reading center - yes | 68 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 6 - central reading center - no | 32 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 6 - investigator - yes | 61 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 6 - investigator - no | 39 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 8 - central reading center - yes | 78 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 8 - central reading center - no | 22 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 8 - investigator - yes | 79 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 8 - investigator - no | 21 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 6 - investigator - yes | 64 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 8 - investigator - yes | 79 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 6 - investigator - no | 36 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 8 - central reading center - yes | 83 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 8 - central reading center - no | 17 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 6 - central reading center - yes | 60 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 6 - central reading center - no | 40 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 8 - investigator - no | 21 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 6 - investigator - yes | 41 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 6 - central reading center - no | 34 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 6 - central reading center - yes | 66 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 6 - investigator - no | 59 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 8 - investigator - yes | 53 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 8 - central reading center - no | 44 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 8 - central reading center - yes | 56 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | week 8 - investigator - no | 47 percentage of subjects |
Comparison: At week 6 - reading centerp-value: =0.81897.06% CI: [-20.3, 25.08]Chi-squared
Comparison: at week 6 - central reading centerp-value: =0.57197.06% CI: [-30.62, 17.96]Chi-squared
Comparison: week 6 - investigatorp-value: =0.06497.06% CI: [-3.11, 43.79]Chi-squared
Comparison: week 6 - investigatorp-value: =0.04197.06% CI: [-0.89, 47.04]Chi-squared
Comparison: week 8 - central reading centerp-value: =0.03197.06% CI: [0.07, 43.64]Chi-squared
Comparison: week 8 - central reading centerp-value: =0.00897.06% CI: [5.57, 48.28]Chi-squared
Comparison: week 8 - investigatorp-value: =0.01197.06% CI: [4.18, 48.01]Chi-squared
Comparison: week 8 - investigatorp-value: =0.01497.06% CI: [3.55, 48.33]Chi-squared
Secondary
Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK
Percentage of patients experiencing deterioration (increase in lesion size ≥ 1mm, decrease in BCDVA by \>5 ETDRS letters, progression in lesion depth to corneal melting or perforation, onset of infection) in stage 2 or 3 NK from baseline to Week 4, 6, and 8.
Time frame: from baseline to Week 4, 6, and 8.
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 4 - yes | 0 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 4 - no | 100 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 6 - yes | 0 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 6 - no | 100 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 8 -yes | 0 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 8 - no | 100 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 4 - no | 100 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 6 - no | 100 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 8 - no | 86 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 4 - yes | 0 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 6 - yes | 0 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 8 -yes | 14 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 8 - no | 100 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 8 -yes | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 6 - no | 100 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 6 - yes | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 4 - yes | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 4 - no | 100 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 6 - no | 98 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 4 - no | 98 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 6 - yes | 2 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 8 - no | 96 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 8 -yes | 4 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 4 - yes | 2 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 4 - yes | 2 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 8 -yes | 7 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 4 - no | 98 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 6 - yes | 0 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 6 - no | 100 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 8 - no | 93 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 6 - no | 90 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 6 - yes | 10 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 8 -yes | 15 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 8 - no | 85 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 4 - no | 95 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK | week 4 - yes | 5 percentage of subjects |
Comparison: week 4p-value: =0.59795% CI: [-22.87, 17.71]Chi-squared
Comparison: week 4p-value: >0.99995% CI: [-23.26, 18.71]Chi-squared
Comparison: week 6p-value: =0.18395% CI: [-28.7, 13.76]Chi-squared
Comparison: week 6p-value: =0.11695% CI: [-31.41, 11.88]Chi-squared
Comparison: week 8p-value: =0.13495% CI: [-31.3, 10.35]Chi-squared
Comparison: week 8p-value: =0.30795% CI: [-29.51, 13.52]Chi-squared
Secondary
Percentage of Patients Experiencing Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer
Complete healing of the PED or corneal ulcer at 4 weeks as defined by the Investigator. The complete healing was defined as the greatest diameter of the corneal fluorescein staining in the area of the PED or corneal ulcer, being less than 0.5 mm at the Week 4 visit. This secondary outcome was analyzed after 4 weeks of treatment only for the Phase II segment of the study. That's why the Phase I groups/arms are not included in this analysis.
Time frame: at 4 weeks of study treatment.
Population: Phase II patients who achieved complete healing at Week 4 (last observation carried forward - LOCF) as determined by the reading center (ITT population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | Yes | 52 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients Experiencing Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | No | 48 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | Yes | 61 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients Experiencing Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | No | 39 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | Yes | 26 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients Experiencing Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer | No | 74 percentage of subjects |
p-value: =0.01697.06% CI: [3.66, 47.87]Chi-squared
p-value: =0.00297.06% CI: [11.91, 57.41]Chi-squared
Secondary
Percentage of Patients That Achieve an Improvement in Corneal Sensitivity
Percentage of patients that achieve an improvement in corneal sensitivity as measured by the Cochet-Bonnet aesthesiometer
Time frame: at 4, 6 and 8 weeks.
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 4 - yes | 67 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 4 - no | 33 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 6 - yes | 67 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 6 - no | 33 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 8 -yes | 67 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 8 - no | 33 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 4 - no | 50 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 6 - no | 50 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 8 - no | 40 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 4 - yes | 50 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 6 - yes | 50 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 8 -yes | 60 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 8 - no | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 8 -yes | 100 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 6 - no | 50 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 6 - yes | 50 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 4 - yes | 50 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 4 - no | 50 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 6 - no | 17 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 4 - no | 31 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 6 - yes | 83 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 8 - no | 21 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 8 -yes | 79 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 4 - yes | 69 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 4 - yes | 61 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 8 -yes | 76 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 4 - no | 39 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 6 - yes | 68 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 6 - no | 32 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 8 - no | 24 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 6 - no | 45 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 6 - yes | 55 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 8 -yes | 68 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 8 - no | 32 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 4 - no | 37 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieve an Improvement in Corneal Sensitivity | week 4 - yes | 63 percentage of subjects |
Comparison: week 4p-value: =0.59295% CI: [-14.53, 25.48]Chi-squared
p-value: =0.83595% CI: [-24.01, 19.4]Chi-squared
Comparison: week 6p-value: =0.00895% CI: [8.1, 47.22]Chi-squared
Comparison: week 6p-value: =0.28295% CI: [-9.91, 34.68]Chi-squared
p-value: =0.30395% CI: [-9.15, 29.45]Chi-squared
Comparison: week 8p-value: =0.44295% CI: [-12.13, 27.92]Chi-squared
Other Pre-specified
Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA
Percentage of patients that achieved a ≥15 letter gain in best corrected distance visual acuity (BCDVA) at 4, 6, and 8 weeks
Time frame: at 4, 6 and 8 weeks
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 8 - no | 83 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 6 - yes | 17 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 8 -yes | 17 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 4 - yes | 0 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 4 - no | 100 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 6 - no | 83 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 8 - no | 57 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 4 - yes | 29 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 6 - yes | 43 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 8 -yes | 43 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 4 - no | 71 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 6 - no | 57 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 6 - yes | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 8 - no | 100 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 4 - no | 100 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 4 - yes | 0 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 6 - no | 100 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 8 -yes | 0 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 4 - no | 63 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 8 - no | 50 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 6 - no | 56 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 4 - yes | 37 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 6 - yes | 44 percentage of subjects |
| 4_rhNGF10_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 8 -yes | 50 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 6 - yes | 38 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 8 -yes | 42 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 6 - no | 62 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 8 - no | 58 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 4 - yes | 34 percentage of subjects |
| 5_rhNGF20_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 4 - no | 66 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 8 - no | 78 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 4 - yes | 21 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 4 - no | 79 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 6 - yes | 28 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 6 - no | 72 percentage of subjects |
| 6_vehicle group_Phase 2_treatment | Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA | week 8 -yes | 22 percentage of subjects |
Comparison: week 4p-value: =0.09795% CI: [-2.36, 33.97]Chi-squared
Comparison: week 4p-value: =0.17595% CI: [-5.72, 32.15]Chi-squared
Comparison: week 6p-value: =0.10595% CI: [-3.11, 37]Chi-squared
Comparison: week 6p-value: =0.395% CI: [-9.64, 31.57]Chi-squared
Comparison: week 8p-value: =0.00895% CI: [8.33, 46.67]Chi-squared
Comparison: week 8p-value: =0.06895% CI: [-0.91, 38.83]Chi-squared