anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Cilostazol
Trial phase: Phase 4
ATC code: B01AC23
SMILES: O=C1CCc2cc(OCCCCc3nnnn3C3CCCCC3)ccc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 125
Group description: Cilostazol 100mg twice per day
Eligibility criteria:
Inclusion Criteria:

Symptomatic cerebral infarction documented on MRI or CT
More than 35 years of age
Patients taking aspirin 100mg a day for 2 weeks or more before randomization

Exclusion Criteria:

Patients taking any antiplatelets other than aspirin within 2 weeks before randomization
Patients taking any anticoagulants within 2 weeks before randomization
Patients taking thrombolytic therapy within 2 weeks before randomization
Patients taking any NSAIDs within 2 weeks before randomization
Patients who need to take NSAIDs regularly (e.g. rheumatic arthritis).
Bleeding diathesis
Chronic liver disease (ALT > 100 or AST > 100) or chronic renal disease (creatinine > 3.0mg/dl)
Anemia (hemoglobin < 10mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3)
Pregnant or lactating patients
Patients scheduled for angioplasty or revascularization procedures within 4 weeks
Patients scheduled for any surgery or invasive procedures within 4 weeks
Patients having acute coronary syndrome
Intervention: Hydrocortisone
Trial phase: Not Applicable
ATC code: A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: milk and molasses enema: enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance
Eligibility criteria:
Inclusion Criteria:

Constipated children who have one of the following three conditions:

Fecal impaction (lower quadrant mass or dilated rectum with hard stool),
Functional fecal retention (large diameter stools as determined by caregiver <twice/week and retentive behaviors, or
Excessive stool in colon on abdominal radiograph as determined by attending radiologist or treating physician

Exclusion Criteria:

Ill appearing patients (signs of acute surgical abdomen, abnormal vital signs, or overall ill appearing as determined by treating physician)
Patients whose evaluation in the ED includes more than plain radiographs or urinalysis
Patients who receive analgesia for the abdominal pain in the ED (except acetaminophen or ibuprofen)
Non-English speaking patients and families
Patients with milk allergy
Patients with molasses allergy
Patients who are pregnant
Patients with a chronic medical conditions which may be associated with constipation (including patients with cystic fibrosis, cerebral palsy, hypothyroidism, spinal anomalies, and known gastrointestinal anatomic abnormalities) or a history of prior abdominal or rectal surgery
Patients who are admitted to an in-patient unit
Intervention: Imiquimod
Trial phase: Not Applicable
ATC code: D06BB10
SMILES: CC(C)Cn1cnc2c(N)nc3ccccc3c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
Eligibility criteria:
Inclusion Criteria:

The presence of plaque-type psoriasis in areas of the trunk, buttocks, or extremities that are amenable to biopsy and evaluable disease in at least 2 cm target treatment sites separated by 1 cm
Age 18-80, both genders, all ethnicities
No contraindications to phototherapy or biopsy procedures
No topical steroid, tar, phototherapy, Vitamin D, or retinoid therapy to target lesions for at least 1 week prior to the study
No systemic psoriasis therapy for at least four weeks prior to the study
Able to give informed consent under IRB approval procedures

Exclusion Criteria:

Photosensitivity disorders
Active untreated diseases or medication usage which may interfere with UVB, wound healing, or immune function
Hypersensitivity to local anesthetic
Inability to provide informed consent
Pregnancy and /or lactating
Intervention: Metformin
Trial phase: Phase 4
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Receiving Metformin for 4 months with a target dose of 1000mg twice a day
Eligibility criteria:
Inclusion Criteria:

Patients aged 25-80 yrs with compensated CHF in NYHA functional I-III with evidence of insulin resistance [fasting insulin resistance index values of > 2.7 are said to have insulin resistance].
Documented Left ventricular systolic dysfunction or LV ejection fraction < 35%

Exclusion Criteria:

Elderly patients (aged >80 yrs);
Patients with decompensated CHF (NYHA functional class IV and /or signs of decompensated CHF);
Renal dysfunction (serum creatinine > 160 mmol/L);
Patients who are unable to exercise including patients that will be excluded for reasons of safety or potential effects on exercise performance. Therefore, patients with angina or other cardiac or pulmonary symptoms potentially limiting exercise performance will be excluded.
Systolic blood pressure >190 mmHg at rest or >250 mmHg with exercise or diastolic blood pressure >95 mmHg at rest or >105 mmHg with exercise will also be a reason for exclusion;
Patients with underlying disease likely to limit life span and/or increase risk of interventions will be excluded i.e., cancer; cardiovascular disease .i.e., uncontrolled hypertension: SBP>180 mmHg or DBP, recent stroke, any severe chronic disease (including renal and hepatic disease).
Intervention: Epicept NP-1
Trial phase: Phase 2
SMILES: Cc1ccc(NCCCN)c([N+](=O)[O-])c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 114
Group description: active topical cream applied twice daily for 4 weeks
Eligibility criteria:
Inclusion Criteria:

Adult patients with chronic pain due to diabetic peripheral neuropathy (DPN) of at least 6 months duration are eligible if they have an average daily pain score of > 4 during the baseline week.

Exclusion Criteria:

Clinically significant intercurrent illness (e.g., endocrine, cardiac, hepatic, renal, neurologic, hematologic, skeletal) that the investigator determines could interfere with the efficacy or safety assessments in this study
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 264
Group description: 2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
Eligibility criteria:
Inclusion Criteria:

Postmenopausal women greater than or equal to 45 and less than or equal to 79 years of age at randomization
Women who are clinically indicated for treatment with Bisphosphonates for osteopenia or osteoporosis with a documented central (spine or hip) Bone Mineral Density T Score less than or equal to 1.5

Exclusion Criteria:

Any prior treatment with intravenous Bisphosphonates
Oral treatment with Bisphosphonates for more than 8 weeks or within 6 months prior to the screening visit
Patients who are taking, and are unwilling or unable to stop taking, certain medications
Patients who require anticoagulant therapy
Patients with a known hypersensitivity to ibuprofen, ACET, bisphosphonates, statins or with allergies manifested by attacks of asthma, urticaria or acute rhinitis following
Proteinuria (protein detected on a urine dipstick) greater than or equal to 2+ at screening
Protocol specific laboratory values that fall out of range for this study
Ongoing infection (oral body temperature greater than or equal to 37.5C (99.5°F),chronic febrile disease or fever of unknown origin at screening or randomization
Active dental infection, unhealed dental extraction or planned oral surgery within 3 months after randomization
History of iritis, uveitis or chronic conjunctivitis
History of hypoparathyroidism, hyperparathyroidism or Paget's Disease
Partial or total removal of parathyroid or thyroid gland
History of malignancy of any organ system, treated or untreated, within the past 1 year whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
Treatment with an investigational drug within the previous 30 days of screening
Patients with any medical or psychiatric condition which, in the opinion of the Principal Investigator, would preclude the participant from adhering to the protocol or completing the trial per protocol, or any patient who the Principal Investigator thinks should not participate in the study for any reason, including current drug or alcohol abuse

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Ribavirin
Trial phase: Phase 4
ATC code: J05AP01
SMILES: NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 189
Group description: Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
Eligibility criteria:
Inclusion Criteria:

Age 18-65 years old
Creatinine clearance (Ccr) < 15 ml/min/1.73 m2
Anti-HCV (Abbott HCV EIA 3.0, Abbott Diagnostic, Chicago, IL) positive > 6 months
Detectable serum quantitative HCV-RNA (Cobas Taqman HCV test, version 2, Roche Diagnostics) with a dynamic range of 25-391000000 IU/ml

Exclusion Criteria:

Receiving interferon-based therapy for chronic hepatitis C
Severe anemia (hemoglobin < 10 g/dL) or hemoglobinopathy
Neutropenia (neutrophil count, <1,500/mm3)
Thrombocytopenia (platelet <90,000/ mm3)
Co-infection with HBV or HIV
Chronic alcohol abuse (daily consumption > 20 g/day)
Autoimmune liver disease
Decompensated liver disease (Child classification B or C)
Neoplastic disease
An organ transplant
Immunosuppressive therapy
Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus
Evidence of drug abuse
Unwilling to have contraception
Intervention: Aclidinium Bromide
Trial phase: Phase 3
ATC code: R03AL05
SMILES: O=C(OC1C[N+]2(CCCOc3ccccc3)CCC1CC2)C(O)(c1cccs1)c1cccs1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 86
Group description: Aclidinium bromide, 200 micrograms, oral inhalation once per day.
Eligibility criteria:
Inclusion Criteria:

A diagnosis of stable moderate to severe COPD (GOLD 2006); post-levalbuterol FEV1 >=30% and < 80% predicted and FEV1/FVC<70% predicted
Current or former cigarette smoker
Functional Residual Capacity (FRC) measured by body plethysmography >= 120% of predicted value
Baseline Dyspnea Index (BDI) focal score ≤ 7 at Visit 4

Exclusion Criteria:

History of presence of asthma, allergic rhinitis, or atopy
Hospitalization for acute COPD exacerbation in the 3 months prior to study entry
Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry
Clinically significant respiratory conditions other than COPD
Chronic use of oxygen therapy >= 15 hours a day
Intervention: Imiquimod
Trial phase: Not Applicable
ATC code: D06BB10
SMILES: CC(C)Cn1cnc2c(N)nc3ccccc3c21
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: This is a pilot study of the use of a topical immunomodulatory agent, imiquimod, for the treatment of recurrent Extramammary Paget's disease (EMPD).
Eligibility criteria:
Inclusion Criteria:

All patients presenting to the Gynecology outpatient service at a participating institution who meet eligibility requirements may be included in this clinical trial. The eligibility requirements are as follows:

Age ≥18.
Ability to give informed consent.
Patients must have biopsy proven recurrent extramammary Paget's disease confirmed at the participating site.

Exclusion Criteria:

Patients with known hypersensitivity to imiquimod.
Pregnant and nursing women are not eligible
Patients with underlying adenocarcinoma on biopsy of lesion confirmed at the participating site.
Intervention: Latanoprost
Trial phase: Phase 4
ATC code: S01EE01 | S01EE51
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: One drop in the study eye, single dose
Eligibility criteria:
Inclusion Criteria:

18 years of age or older.
Clinical diagnosis of ocular hypertension, primary open-angle, pigment dispersion, or exfoliation glaucoma in both eyes.
Best corrected visual acuity of 20/200 Snellen or better in each eye.
Intraocular pressure within protocol-specified range.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Any abnormality preventing reliable applanation tonometry in the study eye(s).
Any eye conditions or procedures as specified in protocol.
Progressive retinal or optic nerve disease from any cause.
Use of contact lenses in the study eye(s).
Other protocol-defined exclusion criteria may apply.
Intervention: Tenofovir Disoproxil Fumarate
Trial phase: Phase 3
SMILES: CC(C)OC(=O)OCOP(=O)(COC(C)Cn1cnc2c(N)ncnc21)OCOC(=O)OC(C)C.O=C(O)C=CC(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 48
Group description: Participants in this group received TDF during the randomized phase (48 weeks)
Eligibility criteria:
Major Inclusion Criteria:

Documented laboratory diagnosis of HIV-1 infection
Plasma HIV-1 RNA < 400 copies/mL
Currently on a stable stavudine or zidovudine -containing antiretroviral therapy regimen for at least 12 weeks
Naive to tenofovir DF

Key Inclusion Criteria for the First 96-Week Extension

Completed 48 weeks of treatment in Arm 1 or Arm 2 of the study
<18 years of age (at the start of the extension)
Participants initially randomized to Arm 2 will be given the option to replace stavudine or zidovudine with tenofovir DF in the 96-week extension at the investigator's discretion, if the investigator determines that tenofovir DF is safe and beneficial for the participant.

Key Inclusion Criteria for the Second and Third 96-Week Extension and Fourth Open-Ended Extension

Completed of treatment with study drug in the first extension phase
<18 years of age at the start of the extension. This inclusion criterion is not applicable in those regions where tenofovir DF is not commercially available for treatment of HIV-1 infection in adults.

Key Exclusion Criteria:

Participants receiving ongoing therapy with any of the following
Nephrotoxic agents
Systemic chemotherapeutic agents
Systemic corticosteroids
Interleukin 2 (IL 2) and other immunomodulating agents
Investigational agents
Pregnant or lactating participants
Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication
Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance
Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma.
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic therapy within 15 days prior to screening
Prior history of significant renal disease (ie, nephrotic syndrome, renal dysgenesis, polycystic kidney disease, congenital nephrosis)
Prior history of significant bone disease (ie, osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochondroses, multiple bone fractures)

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Intervention: Fesoterodine
Trial phase: Phase 3
ATC code: G04BD11
SMILES: CC(C)C(=O)Oc1ccc(CO)cc1[C@H](CCN(C(C)C)C(C)C)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 438
Group description: All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
Eligibility criteria:
Inclusion Criteria:

Overactive bladder symptoms for greater than or equal to 3 months.
Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours in bladder diary.
Mean number of Urgency episodes greater than or equal to 3 per 24 hours in bladder diary.

Exclusion Criteria:

Contraindication to fesoterodine (antimuscarinics).
Known etiology of OAB (e.g., neurogenic, local urinary tract pathology).
Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.
Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.
Intervention: Fluoxymesterone
Trial phase: Phase 3
ATC code: G03BA01
SMILES: [H][C@@]12CC[C@](C)(O)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)CC[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1
Group description: Visual oral exam, followed by OraTest Rinse Staining Procedure
Eligibility criteria:
Inclusion Criteria:

High risk of oral cancer as defined by a twenty-pack/year cigarette smoking history or equivalent and is either a current smoker or has quit smoking within the last 24 months. Twenty-pack/year equivalent is defined as ½ pack/day for 40 years, or one pack/day for 20 years, or 2 packs/day for 10 years, or 4 packs/day for 5 years. AND/OR;
Ten-year history of twenty orally-consumed alcohol units/week and is either a current drinker or has quit drinking within the last 24 months. Twenty orally-consumed alcohol units/week is defined as the equivalent of twenty - 1 ounce shots of whisky or spirits/week (20 ounces = 600 mL), or twenty - 3 ounce glasses of wine/week (60 ounces = 1800 mL), or twenty - 12 ounce glasses of beer/week (240 ounces = 7200 mL);
Male or female, at least 45 years of age;
Written informed consent.
Females of childbearing potential may be enrolled following a negative urine pregnancy test performed at the SE visit. Abstinence will be considered an acceptable form of birth control.

Exclusion Criteria:

History of oral cancer, surgery or biopsy for suspected oral neoplasm;
History of recent oral surgery, periodontal treatment, or oral trauma (<14 days) or current orthodonture (e.g., braces);
Known hypersensitivity to study drug or its analogs;
Active and uncontrolled infection or any other severe concurrent disease that in the judgment of the investigator would make the patient inappropriate for entry into this study;
Psychiatric disorders which would interfere with informed consent or follow-up;
Use of any investigational agent within previous 30 days;
Female that is lactating or demonstrating positive pregnancy test;
Patients in whom betel nut use/abuse has been reported within the past 5 years;
Patients currently taking medication containing prohibited dyes.
Intervention: Latanoprost
Trial phase: Phase 4
ATC code: S01EE01 | S01EE51
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: latanoprost 0.005%
Eligibility criteria:
Inclusion Criteria:

Diagnosis of open-angle glaucoma (pseudoexfoliative or pigmentary glaucomas are allowed) or ocular hypertension

Exclusion Criteria:

Known contraindication to latanoprost, bimatoprost or travoprost
Uncontrolled systemic disease
Active ocular disease other than glaucoma or ocular hypertension
Pregnant or lactating women or women of childbearing potential NOT utilizing a medically acceptable form of birth control
Intervention: Tadalafil
Trial phase: Phase 2
ATC code: C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51
SMILES: [H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: 5 mg by mouth once a day
Eligibility criteria:
Inclusion Criteria:

Have Benign Prostatic Hyperplasia - Lower Urinary Tract Symptoms (BPH-LUTS) for at least 6 months prior to Visit 1.
Agree not to use any other approved or experimental treatments for erectile dysfunction or BPH-LUTS during the study.
Have not taken Finasteride therapy for at least 3 months prior to Visit 2.
Have not taken Dutasteride therapy for at least 6 months prior to Visit 2.
Have an International Prostate Symptom Score (IPSS) total score greater than or equal to 13 at Visit 2.

Exclusion Criteria:

Prostate Specific Antigen (PSA) greater than 10.0 nanograms per milliliter (ng/mL) at Visit 1.
Bladder Post Void Residual (PVR) greater than or equal to 300 mL by ultrasound at Visit 1.
History of pelvic surgery, prostatectomy, radiotherapy, penile implant surgery, lower urinary tract malignancy or trauma.
Urinary tract infection or inflammation or current antibiotic therapy for urinary tract infection at Visit 1.
Glycosylated hemoglobin (HbA1c) greater than 9% at Visit 1.
Intervention: Efavirenz
Trial phase: Phase 3
ATC code: J05AG03 | J05AR06 | J05AR11
SMILES: O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 344
Group description: 600 mg once daily for 96 weeks.
Eligibility criteria:
Inclusion Criteria:

Patient with documented HIV-1 infection
Patient has never been treated with a therapeutic HIV vaccine or an ARV drug prior to screening
Patient's HIV-1 plasma viral load at screening is > 5,000 HIV-1 RNA copies/mL (assayed by RNA PCR standard specimen procedure)
Patient's virus is sensitive to TDF and FTC
Patient agrees not to start ART (antiretroviral treatment) before the baseline visit

Exclusion Criteria:

Previous use of ANY ARV drug for ANY length of time
Any documented evidence of NNRTI resistance associated mutations in patient's HIV
Category C AIDS defining illness, except: stable Kaposi Sarcoma, wasting syndrome if not progressive
Pneumocystis carinii pneumonia (PCP) that is considered not cured
Active TB
Allergy or hypersensitivity to study or background ARTs
Specific grade 3 or 4 toxicity
Kidney impairment: calculated creatinine clearance <50 ml/min
Intervention: Latanoprost
Trial phase: Phase 4
ATC code: S01EE01 | S01EE51
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 586
Group description: Latanoprost 0.005% eye drops
Eligibility criteria:
Inclusion Criteria:

Ocular hypertension or chronic glaucoma
Patient requires IOP-lowering therapy in both eyes

Exclusion Criteria:

Uncontrolled medical conditions
Hypersensitivity to study medications