Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003029-26 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of the study is to assess the safety and tolerability of two dose regimens of recombinant human nerve growth factor (rhNGF) eye drops solution administered over 6 months versus a vehicle control in patients with typical retinitis pigmentosa. The secondary objective of this study is to attempt to show a dose response by assessing the potential efficacy of the rhNGF dose regimens for improving or slowing the deterioration of visual function outcomes at 3 and 6 months. During a 6 month follow-up period patients will be monitored to determine if there is evidence of a persistent biological effect after discontinuation of the study treatment.
This is a 24-week phase Ib/II, multicenter, randomized, double-masked, vehicle controlled, parallel-group, dose-ranging study with a 24-week follow-up period to evaluate the safety and potential efficacy of two doses (60 μg/ml and 180 μg/ml) of recombinant human nerve growth factor (rhNGF) eye drops solution versus vehicle in patients with typical retinitis pigmentosa (RP).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhNGF 60µg/ml | Experimental | rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes |
|
| rhNGF 180 µg/ml | Experimental | rhNGF 180 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes. |
|
| Vehicle | Placebo Comparator | Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhNGF 60 µg/ml eye drops solution | Drug | rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious and Non-Serious Adverse Events | Twenty-seven patients of the Safety population experienced at least one treatment-emergent adverse event, 11 patients in the rhNGF 60 μg/ml arm, 13 patients in the rhNGF 180 μg/ml arm and 3 patients in the vehicle arm. | up to 48 weeks |
| Change in Ocular Tolerability - VAS | A global ocular discomfort score was determined using a 100 mm Visual Analogue Scale (VAS) on which 0 means no symptoms and 100 means the worst possible discomfort. Specific ocular symptoms to be assessed with the VAS included: foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, photophobia. For ocular tolerability analysis, mixed models for repeated measures were applied using various ocular tolerability parameters as response variable, treatment, visit and treatment by visit interaction as fixed effects, and baseline value as covariate. | Weeks 1, 2, 6, 12, 24 |
| Change in Best Corrected Distance Visual Acuity (BCDVA) (ETDRS Chart) | Best-Corrected Distance Visual Acuity (BCDVA) was assessed for each eye at each visit using an ETDRS visual acuity chart at 4 meters. | Weeks 1, 2, 6, 12, 24, 36, 48 |
| Change in Intraocular Pressure (IOP) | Intraocular Pressure was measured using either Goldmann applanation tonometry or a handheld applanation tonometer (e.g. Tonopen) after the instillation of a topical anesthetic.IOP was assessed for each eye at day 0 and at week 2, 12 and 24 | Weeks 2,12 and 24 |
| Number of Participants With Normal or Abnormal Findings by Slit Lamp Examination | Slit Lamp Examination (SLE) (Biomicroscopy) was performed before the instillation of any dilating or anesthetic eye drops or fluorescein agents. SLE was executed to assess eyelids, lashes, conjunctiva, cornea, lens, iris and anterior chamber. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Contrast Sensitivity | Contrast sensitivity was assessed using a Mars chart and is expressed as a log contrast sensitivity (log CS) score given by the log CS value at the lowest contrast numeral just prior to two incorrectly identified numerals, minus a scoring correction. The higher is the number of characters properly read by the patient, the higher is the contrast sensitivity. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Flavio Mantelli, MD, PhD | Dompé farmaceutici S.p.A., Milan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Universitaria Careggi | Florence | 50124 | Italy | |||
| Azienda Ospedaliera San Paolo - U.O. Oculistica |
Fifty patients were enrolled in the study. Two additional patients provided valid, written, informed consent but were not randomized due to screening failure. No study medication was administered to these patients.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | rhNGF 60µg/ml | rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes rhNGF 60 µg/ml eye drops solution: rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes |
| FG001 | rhNGF 180 µg/ml |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| rhNGF 180 µg/ml eye drops solution | Drug | rhNGF 180 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes |
|
|
| Placebo | Drug | Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes |
|
|
| Day 0; Weeks 1, 2, 6, 12, 24, 36 and 48 |
| External Ocular Examination | External ocular examinations were done to assess, for each eye and at each visit, the motility of extraocular muscles, appearance and function of the eyelids. | Day 0, Weeks 1, 2, 6, 12, 24 |
| Change in Ocular Tolerability - Dilated Fundus Ophthalmoscopy | Dilated fundus ophthalmoscopy was assessed for each eye evaluating the retina, macula, choroid and optic nerve head. | Day 0, Weeks 12, 24 and 48 |
| Presence of Anti-NGF Antibodies | Anti-NGF antibodies tests were performed at screening and at the end of treatment | At Day 0 and at week 24 |
| Weeks 12, 24, 36 and 48 |
| Change From Baseline in Humphrey Visual Field 24-2 | The Humphrey Visual Field (HVF) analyzer is a tool for measuring the human visual field by providing information regarding the location of any disease processes or lesion(s) throughout the visual pathway. In particular, Humphrey Visual Field 24-2 was used to assess static perimetry by measuring 24 degrees temporally and 30 degrees nasally and tests 54 points. The Analyser projects a series of white light stimuli of varying intensities (brightness), throughout a uniformly illuminated bowl. The higher is the number of stimuli perceived by the patient, the better is the retina's ability to detect a stimulus at specific points within the visual field. | Weeks 12, 24, 36 and 48 |
| Change in Goldmann Visual Field | The Goldmann field exam was performed to assess kinetic perimetry on all enrolled patients. | Weeks 12, 24, 36 and 48 |
| Fundus Imaging | A recordable fundus image (photo or other electronic format) showing the central 30 degrees was captured through a dilated pupil to document the appearance of the posterior pole. | Day 0, Weeks 24 and 48 |
| Ocular Coherence Tomography (OCT) | Ocular coherence tomography was performed to evaluate the cross-sectional anatomy of the macula and to document areas of retinal atrophy. | Day 0, Weeks 12, 24, 36 and 48 |
| Microperimetry | MP1 microperimetry was analyzed to provide a more accurate measurement of retinal sensitivity in the central visual field, even in patients with unstable or extrafoveal fixation. | Day 0, Weeks 12, 24, 36 and 48 |
| Binocular Estermann Visual Field | Binocular visual field with Estermann grid testing a stimulus array of 120 points spread over an area extending approximately ±75° horizontally, 35° superiorly and 55° inferiorly while the patient looked steadily at the fixation target. | Day 0, Weeks 12, 24, 36 and 48 |
| Electrorethinogram (ERG) | A full field and 30 Hz flicker ERG was performed according to international standards. Patients were treated with anesthetic and dilating drops prior to the ERG procedure. | Day 0, Weeks 12, 24, 36 and 48 |
| Milan |
| 20142 |
| Italy |
| A.O. Seconda Università Degli Studi di Napoli - Nuovo Policlinico - UOC Oftalmologia | Naples | 80129 | Italy |
| Università Cattolica del Sacro Cuore - Policlinico Gemelli - Istituto di Oftalmologia | Rome | 00168 | Italy |
| IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia | Rome | 00198 | Italy |
rhNGF 180 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes. rhNGF 180 µg/ml eye drops solution: rhNGF 180 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes |
| FG002 | Vehicle | Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes. Placebo: Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population: all patients who received at least one dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | rhNGF 60µg/ml | rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes rhNGF 60 µg/ml eye drops solution: rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes |
| BG001 | rhNGF 180 µg/ml | rhNGF 180 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes. rhNGF 180 µg/ml eye drops solution: rhNGF 180 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes |
| BG002 | Vehicle | Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes. Placebo: Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Serious and Non-Serious Adverse Events | Twenty-seven patients of the Safety population experienced at least one treatment-emergent adverse event, 11 patients in the rhNGF 60 μg/ml arm, 13 patients in the rhNGF 180 μg/ml arm and 3 patients in the vehicle arm. | Safety population: all patients who received at least one dose of study medication. The safety population was used to analyze all safety endpoints (primary objective). | Posted | Count of Participants | Participants | up to 48 weeks |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Change in Ocular Tolerability - VAS | A global ocular discomfort score was determined using a 100 mm Visual Analogue Scale (VAS) on which 0 means no symptoms and 100 means the worst possible discomfort. Specific ocular symptoms to be assessed with the VAS included: foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, photophobia. For ocular tolerability analysis, mixed models for repeated measures were applied using various ocular tolerability parameters as response variable, treatment, visit and treatment by visit interaction as fixed effects, and baseline value as covariate. | Safety population: patients who received at least one dose of study medication. The safety population was used to analyze all safety endpoints (primary objective). | Posted | Mean | Standard Deviation | units on a scale | Weeks 1, 2, 6, 12, 24 |
| |||||||||||||||||||||||||||||||||
| Primary | Change in Best Corrected Distance Visual Acuity (BCDVA) (ETDRS Chart) | Best-Corrected Distance Visual Acuity (BCDVA) was assessed for each eye at each visit using an ETDRS visual acuity chart at 4 meters. | Safety population: patients who received at least one dose of study medication. The safety population was used to analyze all safety endpoints (primary objective). | Posted | Mean | Standard Deviation | Letters read correctly | Weeks 1, 2, 6, 12, 24, 36, 48 |
| |||||||||||||||||||||||||||||||||
| Primary | Change in Intraocular Pressure (IOP) | Intraocular Pressure was measured using either Goldmann applanation tonometry or a handheld applanation tonometer (e.g. Tonopen) after the instillation of a topical anesthetic.IOP was assessed for each eye at day 0 and at week 2, 12 and 24 | Safety population: patients who received at least one dose of study medication. The safety population was used to analyze all safety endpoints (primary objective). | Posted | Mean | Standard Deviation | mmHg | Weeks 2,12 and 24 |
| |||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Normal or Abnormal Findings by Slit Lamp Examination | Slit Lamp Examination (SLE) (Biomicroscopy) was performed before the instillation of any dilating or anesthetic eye drops or fluorescein agents. SLE was executed to assess eyelids, lashes, conjunctiva, cornea, lens, iris and anterior chamber. | s | Posted | Count of Participants | Participants | Day 0; Weeks 1, 2, 6, 12, 24, 36 and 48 |
| ||||||||||||||||||||||||||||||||||
| Primary | External Ocular Examination | External ocular examinations were done to assess, for each eye and at each visit, the motility of extraocular muscles, appearance and function of the eyelids. | Safety population: all patients who received at least one dose of study medication. The safety population was used to analyze all safety endpoints (primary objective). | Posted | Count of Participants | Participants | Day 0, Weeks 1, 2, 6, 12, 24 |
| ||||||||||||||||||||||||||||||||||
| Primary | Change in Ocular Tolerability - Dilated Fundus Ophthalmoscopy | Dilated fundus ophthalmoscopy was assessed for each eye evaluating the retina, macula, choroid and optic nerve head. | Safety population: all patients who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 0, Weeks 12, 24 and 48 |
| ||||||||||||||||||||||||||||||||||
| Primary | Presence of Anti-NGF Antibodies | Anti-NGF antibodies tests were performed at screening and at the end of treatment | Safety population: all patients who received at least one dose of study medication. The safety population was used to analyze all safety endpoints (primary objective). | Posted | Count of Participants | Participants | At Day 0 and at week 24 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Contrast Sensitivity | Contrast sensitivity was assessed using a Mars chart and is expressed as a log contrast sensitivity (log CS) score given by the log CS value at the lowest contrast numeral just prior to two incorrectly identified numerals, minus a scoring correction. The higher is the number of characters properly read by the patient, the higher is the contrast sensitivity. | Intent to treat (ITT) population: all randomized patients. The ITT population was used for the exploratory analyses of ocular parameters. | Posted | Mean | Standard Deviation | score | Weeks 12, 24, 36 and 48 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Humphrey Visual Field 24-2 | The Humphrey Visual Field (HVF) analyzer is a tool for measuring the human visual field by providing information regarding the location of any disease processes or lesion(s) throughout the visual pathway. In particular, Humphrey Visual Field 24-2 was used to assess static perimetry by measuring 24 degrees temporally and 30 degrees nasally and tests 54 points. The Analyser projects a series of white light stimuli of varying intensities (brightness), throughout a uniformly illuminated bowl. The higher is the number of stimuli perceived by the patient, the better is the retina's ability to detect a stimulus at specific points within the visual field. | Intent to treat (ITT) population: all randomized patients. The ITT population was used for the exploratory analyses of ocular parameters. | Posted | Mean | Standard Deviation | dB | Weeks 12, 24, 36 and 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Goldmann Visual Field | The Goldmann field exam was performed to assess kinetic perimetry on all enrolled patients. | Intent to treat (ITT) population: all randomized patients. The ITT population was used for the exploratory analyses of ocular parameters. | Posted | Mean | Standard Deviation | degrees | Weeks 12, 24, 36 and 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Fundus Imaging | A recordable fundus image (photo or other electronic format) showing the central 30 degrees was captured through a dilated pupil to document the appearance of the posterior pole. | Intent to treat (ITT) population: all randomized patients. The ITT population was used for the exploratory analyses of ocular parameters. | Posted | Count of Participants | Participants | Day 0, Weeks 24 and 48 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Ocular Coherence Tomography (OCT) | Ocular coherence tomography was performed to evaluate the cross-sectional anatomy of the macula and to document areas of retinal atrophy. | Intent to treat (ITT) population: all randomized patients. The ITT population was used for the exploratory analyses of ocular parameters. | Posted | Count of Participants | Participants | Day 0, Weeks 12, 24, 36 and 48 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Microperimetry | MP1 microperimetry was analyzed to provide a more accurate measurement of retinal sensitivity in the central visual field, even in patients with unstable or extrafoveal fixation. | Intent to treat (ITT) population: all randomized patients. The ITT population was used for the exploratory analyses of ocular parameters. | Posted | Count of Participants | Participants | Day 0, Weeks 12, 24, 36 and 48 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Binocular Estermann Visual Field | Binocular visual field with Estermann grid testing a stimulus array of 120 points spread over an area extending approximately ±75° horizontally, 35° superiorly and 55° inferiorly while the patient looked steadily at the fixation target. | Intent to treat (ITT) population: all randomized patients. The ITT population was used for the exploratory analyses of ocular parameters. | Posted | Count of Participants | Participants | Day 0, Weeks 12, 24, 36 and 48 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Electrorethinogram (ERG) | A full field and 30 Hz flicker ERG was performed according to international standards. Patients were treated with anesthetic and dilating drops prior to the ERG procedure. | Intent to treat (ITT) population: all randomized patients. The ITT population was used for the exploratory analyses of ocular parameters. | Posted | Count of Participants | Participants | Day 0, Weeks 12, 24, 36 and 48 |
|
Weeks 1, 2, 6, 12 and 24, plus follow-up at weeks 36 and 48
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | rhNGF 60µg/ml | rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes rhNGF 60 µg/ml eye drops solution: rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes | 0 | 20 | 1 | 20 | 11 | 20 |
| EG001 | rhNGF 180 µg/ml | rhNGF 180 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes. rhNGF 180 µg/ml eye drops solution: rhNGF 180 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes | 0 | 20 | 0 | 20 | 13 | 20 |
| EG002 | Vehicle | Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes. Placebo: Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes | 0 | 10 | 0 | 10 | 3 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extrasystoles | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abnormal sensation in eye | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Conjunctival hyperemia | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Corneal epitelium defect | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Eyelid pain | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Night blindness | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
|
LImitations and caveats non specified
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Flavio Mantelli, MD, PhD | Dompé farmaceutici s.p.a. | +39 02 583831 | clinical.trials@dompe.com |
| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| D000071700 | Cone-Rod Dystrophies |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| C000647429 | cenegermin |
| D009883 | Ophthalmic Solutions |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Vehicle |
Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes. Placebo: Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
| OG002 |
| Vehicle |
Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes. Placebo: Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|