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Completed

NCT Number: NCT01647217

Demodex Blepharitis Treatment Study

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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Key information

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ocular Surface Center

Miami, Florida, 33173, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with symptomatic Demodex blepharitis for duration of at least 3 months.
  • Age range: 15-80 years old.
  • Both genders and all ethnic groups comparable with the local community.
  • Able to understand and willing to sign a written informed consent
  • Able and willing to cooperate with the investigational plan.
  • Able and willing to complete all mandatory follow-up visits.

Exclusion criteria

  • Patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits.
  • Children under 15.
  • Pregnant women or expecting to be pregnant during the study.
  • Systemic immune deficient conditions such as AIDS or under systemic immunosuppressant.
  • Concomitant use of ophthalmic topical medications (excluding non-preserved tear substitutes).
  • Concomitant use of systemic antibiotics or steroids.
  • Contact lens wear (unless discontinued for ≥ 30 days before randomization)
  • Active ocular infection or allergy
  • Unable to close eyes or uncontrolled blinking
  • Presence of aqueous tear deficient dry eye defined by the Fluorescein Clearance Test as less than 3 mm wetting in 1-minute Schirmer test with anesthesia.
  • Previous allergic reaction to TTO-containing products or cosmetic fragrance.

Treatment and study plan

Terpinen-4-ol

Drug

Lid scrub once or twice per day for one month.

Other names: T4O

Placebo

Other

Lid scrub once or twice per day for one month

Primary outcomes

  1. Change in the Number of Demodex Mites

    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".

Secondary outcomes

  1. Change in Lid Margin Redness and Bulbar Conjunctival Hyperemia

    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).

Sponsors and collaborators

Lead sponsor

BioTissue Holdings, Inc

Industry

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

Safety and Efficacy of Single-use Terpinen-4-ol Pads for Treating Ocular Mites A Randomized Clinical Trial

Acronym: DBTS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 23, 2012
Registry last updated
Jul 26, 2017

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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