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Comparison of the anesthetic effect of different dosages of tetracaine 0.5% ophthalmic solution on corneal sensation

Comparison of the anesthetic effect of different dosages of tetracaine 0.5% ophthalmic solution on corneal sensation in healthy adults

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001289808
Enrollment
81
Registered
2021-09-23
Start date
2019-12-20
Completion date
2019-12-27
Last updated
2021-09-27

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

Conditions

None listed

Brief summary

Primary purpose. To measure and to compare the anesthetic effect of 1, 2 or 3 drops of 0.5% tetracaine hydrochloryde, at 3 minutes intervals on corneal sensation. Hypothesis. The anesthetic effect will be greater at a greater dosage of tetracaine.

Interventions

Group 2. Subjects will receive 1 drop of placebo (balanced salt solution) and two of 0.5% tetracaine hydrochloride ophthalmic solution at 3 minutes intervals topically in the right eye. Group 3. This group will receive 3 drops of 0.5% tetracaine hydrochloride ophthalmic at 3 minutes intervals topically in the right eye. Strategy to monitor adherence: drops were applied by a physician different from the physician measuring corneal sensation. Patients did not have to apply any drop by themselves

Group 2. Subjects will receive 1 drop of placebo (balanced salt solution) and two of 0.5% tetracaine hydrochloride ophthalmic solution at 3 minutes intervals topically in the right eye. Group 3. This group will receive 3 drops of 0.5% tetracaine hydrochloride ophthalmic at 3 minutes intervals topically in the right eye. Strategy to monitor adherence: drops were applied by a physician different from the physician measuring corneal sensation. Patients did not have to apply any drop by themselves nor were given any medication to withhold during the intervention period. Placebo: balanced salt solution (BSS®, Alcon Laboratories, Inc.) composition per mL includes sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride dihydrate 0.048%, magnesium chloride hexahydrate 0.03%, sodium acetate trihydrate 0.39%, sodium citrate dihydrate 0.17%, sodium hydroxide and/or hydrochloric acid, and water for injection.

Sponsors

Universidad Autónoma de Yucatán
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026