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The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R348 Ophthalmic Solution, 0.2% | Active Comparator | R348 Ophthalmic Solution, 0.2% |
|
| R348 Ophthalmic Solution, 0.5% | Active Comparator | R348 Ophthalmic Solution, 0.5% |
|
| Placebo | Placebo Comparator | Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R348 Ophthalmic Solution, 0.2% | Drug | R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Corneal Fluorescein Staining of the Inferior Cornea Region. | Change from baseline (Visit 3) of inferior region CFS score at 12 weeks. Inferior region CFS score range 0-4, where '0' represents no fluorescein staining and '4' represents severe staining on the cornea. | Baseline to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Magilavy, MD | Rigel Pharmaceuticals,Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sall Research Medical Center | Artesia | California | 90701 | United States | ||
| North Bay Eye |
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| ID | Title | Description |
|---|---|---|
| FG000 | R348 Ophthalmic Solution, 0.2% | R348 Ophthalmic Solution, 0.2% R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks. |
| FG001 | R348 Ophthalmic Solution, 0.5% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| R348 Ophthalmic Solution, 0.5% | Drug | R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks. |
|
|
| Placebo | Drug | Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks. |
|
| Petaluma |
| California |
| 94954 |
| United States |
| Martel Medical Eye Group | Rancho Cardova | California | 95670 | United States |
| Specialty Eye Care | Parker | Colorado | 808134 | United States |
| International Research Center | Brandon | Florida | 33603 | United States |
| East Florida Eye Institute | Stuart | Florida | 34994 | United States |
| Clayton Eye Center | Morrow | Georgia | 30260 | United States |
| Coastal Research Associates | Roswell | Georgia | 30076 | United States |
| Chicago Research Center | Chicago | Illinois | 60634 | United States |
| Chicago Cornea Consultants | Hoffman Estates | Illinois | 60169 | United States |
| Koffler Vision Group | Lebanon | Kentucky | 40033 | United States |
| Taustine Eye Center | Louisville | Kentucky | 40217 | United States |
| Comprehensive Eye Care, Ltd/Vision Research Institute, LLC | Washington | Missouri | 63090 | United States |
| Mundorf Eye Center | Charlotte | North Carolina | 28204 | United States |
| Charlotte Eye Ear Nose and Throat Associates, PA | Charlotte | North Carolina | 28210 | United States |
| Cornerstone Eyecare | High Point | North Carolina | 27262 | United States |
| Abrams Eye Center | Cleveland | Ohio | 44115 | United States |
| Glaucoma Consultants and Center for Eye Research | Mt. Pleasant | South Carolina | 29464 | United States |
| Chattanooga Eye Institute | Chattanooga | Tennessee | 37411 | United States |
| Eye Clinics of South Texas | San Antonio | Texas | 78209 | United States |
R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.
| FG002 | Placebo | Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks. Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | R348 Ophthalmic Solution, 0.2% | R348 Ophthalmic Solution, 0.2% R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks. |
| BG001 | R348 Ophthalmic Solution, 0.5% | R348 Ophthalmic Solution, 0.5% R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks. |
| BG002 | Placebo | Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks. Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks. |
| 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, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Change of Corneal Fluorescein Staining of the Inferior Cornea Region. | Change from baseline (Visit 3) of inferior region CFS score at 12 weeks. Inferior region CFS score range 0-4, where '0' represents no fluorescein staining and '4' represents severe staining on the cornea. | The intent to treat population (ITT) included all randomized subjects who administered study medication. The primary analysis was performed on the ITT population. | Posted | Mean | 95% Confidence Interval | units on a scale (Likert) | Baseline to Week 12 |
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The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | R348 Ophthalmic Solution, 0.2% | R348 Ophthalmic Solution, 0.2% R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks. | 3 | 67 | 36 | 67 | ||
| EG001 | R348 Ophthalmic Solution, 0.5% | R348 Ophthalmic Solution, 0.5% R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks. | 1 | 68 | 46 | 68 | ||
| EG002 | Placebo | Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks. Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks. | 2 | 69 | 31 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rectal haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Malignant hyperthermia | General disorders | Non-systematic Assessment |
| ||
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Chest pain | General disorders | Non-systematic Assessment |
| ||
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure Congestive | Cardiac disorders | Non-systematic Assessment |
| ||
| Sinus Tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Eye Discharge | Eye disorders | Non-systematic Assessment |
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| Conjunctival Hyperaemia | Eye disorders | Non-systematic Assessment |
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| Blepharitis | Eye disorders | Non-systematic Assessment |
| ||
| Chalazion | Eye disorders | Non-systematic Assessment |
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| Conjunctival Haemorrhage | Eye disorders | Non-systematic Assessment |
| ||
| Meibomianitis | Eye disorders | Non-systematic Assessment |
| ||
| Periorbital Oedema | Eye disorders | Non-systematic Assessment |
| ||
| Ocular Hyperaemia | Eye disorders | Non-systematic Assessment |
| ||
| Conjunctival Cyst | Eye disorders | Non-systematic Assessment |
| ||
| Conjunctival Disorder | Eye disorders | Non-systematic Assessment |
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| Conjunctivitis Allergic | Eye disorders | Non-systematic Assessment |
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| Eye Pain | Eye disorders | Non-systematic Assessment |
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| Punctate Keratitis | Eye disorders | Non-systematic Assessment |
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| Trichiasis | Eye disorders | Non-systematic Assessment |
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| Lacrimation Increased | Eye disorders | Non-systematic Assessment |
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| Corneal Abrasion | Eye disorders | Non-systematic Assessment |
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| Keratitis | Eye disorders | Non-systematic Assessment |
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| Photophobia | Eye disorders | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Rectal Haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
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| Salivary Duct Obstruction | Gastrointestinal disorders | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | Non-systematic Assessment |
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| Instillation Site Pain | General disorders | Non-systematic Assessment |
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| Instillation Site Pruritus | General disorders | Non-systematic Assessment |
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| Chest Pain | General disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| instillation Site Paraesthesia | General disorders | Non-systematic Assessment |
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| Instillation Site Discomfort | General disorders | Non-systematic Assessment |
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| Hyperthermia Malignant | General disorders | Non-systematic Assessment |
| ||
| Hypersensitivity | Immune system disorders | Non-systematic Assessment |
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| Urinary Track Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Influenza | Infections and infestations | Non-systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Non-systematic Assessment |
| ||
| Upper Respiratory Tract Infection | Infections and infestations | Non-systematic Assessment |
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| Tooth Abscess | Infections and infestations | Non-systematic Assessment |
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| Herpes Zoster | Infections and infestations | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Non-systematic Assessment |
| ||
| Hordeolum | Infections and infestations | Non-systematic Assessment |
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| Kidney Infection | Infections and infestations | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | Non-systematic Assessment |
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| Sinusitis Bacterial | Infections and infestations | Non-systematic Assessment |
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| Post Procedural Infection | Infections and infestations | Non-systematic Assessment |
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| Cystitis | Infections and infestations | Non-systematic Assessment |
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| Otitis Media | Infections and infestations | Non-systematic Assessment |
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| Tooth Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Blood Pressure Increased | Investigations | Non-systematic Assessment |
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| Urine Analysis Abnormal | Investigations | Non-systematic Assessment |
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| Intraocular Pressure Increased | Investigations | Non-systematic Assessment |
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| Manifest Refraction | Investigations | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Systemic Lupus Erythematosus | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Intervertebral Disc Protusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Viith Nerve Paralysis | Nervous system disorders | Non-systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Depression | Psychiatric disorders | Non-systematic Assessment |
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| Glycosuria | Renal and urinary disorders | Non-systematic Assessment |
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| Nasal Discomfort | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Tooth Extraction | Surgical and medical procedures | Non-systematic Assessment |
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| Rotator Cuff Repair | Surgical and medical procedures | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne-Marie Duliege, MD | Rigel | 650-624-1100 | clinicaltrials@rigel.com |
| ID | Term |
|---|---|
| D007638 | Keratoconjunctivitis Sicca |
| ID | Term |
|---|---|
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
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| Male |
|