Clinical profile and drug stability of the mixture of 0.5% tetracaine, 0.75% tropicamide and 2.5% phenylephrine

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20201009002

Enrollment

Registered

2020-10-09

Start date

2020-10-09

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mydriatic and anesthetic combination eye drop Tetracaine Tropicamide Phenylephrine Combination Eye drop Mydriatic Anesthetic

Interventions

The combination eye drops of 4.8 mL of 0.5% Tetracaine HCl and 1.2 mL of 10% phenylephrine : 1% Mydriacly (1:3) (total voulume 6 mL) was prepared in aseptic technique.

Experimental Drug

Eye drop mixture:0.5% tetracaine&#44

0.75% tropicamide and 2.5% phenylephrine

Eligibility

Sex/Gender

All

Age

31 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. DM patients without intravitreous injection treatment 2. No health condition or current drug use that affects pupillary dilation. 3. No health condition that affects corneal sensation.

Exclusion criteria

Exclusion criteria: 1. History of allergy to the study drug 2. Health conditions that are not allowed to use the study drug (arrhythmia, ischemic heart disease)

Design outcomes

Primary

Measure	Time frame
Drug stability 0 ,30, 60, 90, 120, 150, 180 days Physical properties and pH,Pupil size (mm) [Mydratic ability] 10 min, 20 min, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr Pupil gauge,C-B Filament length (cm) converted to Pressure (g/mmÂ²) [Anesthetic ability] 10 min, 20 min, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr Cochet-Bonnet Esthesiometer,Pain score (points) [Anesthetic ability] 10 min, 20 min, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr Numerical rating scale (0-10)	—

Measure

Time frame

Drug stability 0 ,30, 60, 90, 120, 150, 180 days Physical properties and pH,Pupil size (mm) [Mydratic ability] 10 min, 20 min, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr Pupil gauge,C-B Filament length (cm) converted to Pressure (g/mmÂ²) [Anesthetic ability] 10 min, 20 min, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr Cochet-Bonnet Esthesiometer,Pain score (points) [Anesthetic ability] 10 min, 20 min, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr Numerical rating scale (0-10)

—

Secondary

Measure	Time frame
Difference of drug-response between healthy subjects and patients wth diabetic retinopathy 10 min, 20 min, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr Statistical analysis comparing of mydriatic and ansethetic ability	—

Countries

Thailand

Contacts

Public ContactSupalert Prakhunhungsit

Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University

off_sp25@hotmail.com+66814441734

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026

Clinical profile and drug stability of the mixture of 0.5% tetracaine&#44; 0.75% tropicamide and 2.5% phenylephrine