Ocular Surface Center
Miami, Florida, 33173, United States
NCT Number: NCT01647217
This is a randomized clinical trial to determine the safety and efficacy of terpinen-4-ol (T4O), the most active ingredient of tea tree oil (TTO), in eradicating ocular demodicosis (reducing ocular demodex counts and achieving the clinical improvement with minimal or no irritation).
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Notify Me15 year–80 year
All sexes
Interventional
Phase 1
Miami, Florida, 33173, United States
Demodex blepharitis is one of the most common causes of chronic blepharitis. The investigators preliminary clinical study showed that lid scrub with TTO was effective in resolving chronic blepharoconjunctivitis; however, it was not convenient for self-administration and caused irritation in some patients. Preclinical safety studies have verified that T4O is less irritant. In this study, the investigators will determine the optimal regimen of T4O Pads.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lid scrub once or twice per day for one month.
Other names: T4O
Lid scrub once or twice per day for one month
Time frame: 6 weeks
Change in mites count after treatment compared to the baseline data. If the mites' count remains zero during the last two visits, it is considered "complete eradication". Patients without achieving complete eradication will be categorized as "incomplete eradication".
Time frame: Baseline and 6 weeks
Lid margin redness and bulbar conjunctival hyperemia were each assessed using an ordered categorical value ranging from 0 (None) to 3 (Severe). The two scores were summed to obtain the final score, which ranges from 0 (None) to 6 (Severe).
BioTissue Holdings, Inc
Industry
Safety and Efficacy of Single-use Terpinen-4-ol Pads for Treating Ocular Mites A Randomized Clinical Trial
Acronym: DBTS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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