ACTRN12621001289808
Completed
Phase 4
Comparison of the anesthetic effect of different dosages of tetracaine 0.5% ophthalmic solution on corneal sensation in healthy adults
niversidad Autónoma de Yucatán0 sites81 target enrollmentSeptember 23, 2021
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Corneal sensation
- Sponsor
- niversidad Autónoma de Yucatán
- Enrollment
- 81
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
- Research question. What is the effect of different dosages of tetracaine 0.5% ophthalmic solution on corneal sensation? 2. Background information. Tetracaine hydrochloride ophthalmic solution is a long action aminoesther local anesthetic. It is used widely on ophthalmology at a 0.5% solution. The recomended dosage depends on the manufacturer and goes from a single drop to 5 drops applied at 5 minutes intervals, and there are trials assessing the security and efficacy on different settings. Nevertheless, we did not find any trial comparing the efficacy of different dosages on humans. 3. Participants characteristics. Healthy subjects 18 years old or older. 4. Key results. The Duration of the maximal anesthetic effect was longer when tetracaine was applied at a greater dosage. The duration of corneal anesthesia was similar in the three groups. The degree of the maximal anesthetic effect was greater with a greater dosage. Baseline corneal sensation was similar in males and females. There were no severe adverse events derived from the use of Cochet-Bonnet or tetracaine. Limitations. 5. Limitations. Balanced salt solution as placebo does not cause a burning sensation like tetracaine, thus probably affecting the blinding. Cochet Bonnet anesthesiometer measures superficial touch sensitivity, and the results may vary when transposed to a surgical setting. We did not measure sensation beyond 63 minutes, affecting the results regarding the duration of corneal anesthesia.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy subjects.
- •18 years old or older.
Exclusion Criteria
- •Any known systemic disease.
- •Any known ophthalmic disease.
- •Contact lens wear.
- •Previous ophthalmic surgery.
- •The presence of symptoms or signs of any ophthalmic disease.
Outcomes
Primary Outcomes
Not specified
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