Here is the design of a clinical trial:

Official Title: PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity

Included conditions:
- Retinopathy of Prematurity

Study Armgroups:
- {'label': 'Ripasudil eye drops', 'type': 'EXPERIMENTAL', 'description': 'Ripasudil eye drops', 'interventionNames': ['Drug: Ripasudil ophthalmic solution 0.4%']}

Interventions:
- {'type': 'DRUG', 'name': 'Ripasudil ophthalmic solution 0.4%', 'description': 'Phase1 A total of three infants will receive ripasudil eye drops(0.4%) once daily for one week, followed by twice-daily drug administration for two weeks. The three infants who participate in Phase1 can continue to receive the eye drop treatment for additional 9 weeks(12 weeks in total)if the investigators determine that there are no safety issues with ripasudil. In addition, a data and safety monitoring board(DSMB)will be held two times to decide whether the new patients can be enrolled into phase1, and also if phase2 can begin.\n\nPhase2:A total of 21 patients will receive ripasudil eye drops(0.4%)twice daily for 12 weeks.', 'armGroupLabels': ['Ripasudil eye drops'], 'otherNames': ['GLANATEC ophthalmic solution 0.4%']}

Primary Outcomes:
- {'measure': 'Proportion of patients with Adverse Events(AEs) and Adverse Drug Reactions(ADRs)', 'description': 'Safety Assessment', 'timeFrame': 'throughout the study duration(up to week16)'}

Please estimate the sample size based on the assumption: 
Dropout rate of about 10% for medical record screening, consent acquisition rate of approximately 35%, and a dropout rate of about 15% after inclusion.
Sample size
        A total of 24 patients (3 in phase I and 21 in phase II) will be enrolled in this trial. Based on the past medical records, the number of new subjects per month who were considered to be eligible for this clinical trial was eight. Assuming a dropout rate of about 10% for medical record screening, a consent acquisition rate of approximately 35% and a dropout rate of about 15% after inclusion, approximately five cases were expected to be included during the planned registration period of phase I. In phase II, the number of newly eligible patients is expected to be approximately 95 and a total of approximately 25 cases can be expected to be included during the registration period.