CompletedPhase 4ACTRN12621001289808

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


Sponsor

Universidad Autónoma de Yucatán

Enrollment

75 participants

Start Date

Dec 20, 2019

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria2

  • Healthy subjects.
  • years old or older.

Exclusion Criteria5

  • Any known systemic disease.
  • Any known ophthalmic disease.
  • Contact lens wear.
  • Previous ophthalmic surgery.
  • The presence of symptoms or signs of any ophthalmic disease.

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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. Thi

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.


Locations(1)

Yucatán, Mexico

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ACTRN12621001289808