Effect of 0.5% ketorolac tromethamine eye drop temperature on ocular comfort

For healthy adults aged 18 to 45 years, will refrigeration of 0.5% ketorolac tromethamine eye drops, compared to room temperature ketorolac tromethamine eye drops, improve subjective ocular comfort?

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000296831

Enrollment

Registered

2012-03-15

Start date

2012-07-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The use of topical ocular non-steroidal anti-inflammatory drugs (NSAIDs) has been limited by the common side effects of burning and stinging. It has been reported that lowering the temperature of lubricant eye drops results in improved ocular comfort. This research project is to determine if refrigeration of 0.5% ketorolac tromethamine prior to administration improves patient tolerability of the commercially available preparation. These findings may lead to an improved method of delivery that will reduce the adverse effect profile of topical NSAIDs, increase patient compliance and influence future prescribing trends.

Interventions

1 drop of refrigerated (at approximately 4 degrees Celsius) 0.5% ketorolac tromethamine will be administered in one eye of the subject.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy adults aged 18-45 years

Exclusion criteria

No ocular surface disease, no contact lens wearers

Outcome results