Meibomian Gland DysfunctionPhase 2NCT00755183
Safety and Efficacy Study of a Testosterone Eye Drop for the Treatment of Meibomian Gland Dysfunction
A Phase 2 study testing testosterone ophthalmic solution in people with Meibomian Gland Dysfunction, run by ORA, Inc. at 1 site in United States.
Trial summary
The objective of this study is to assess the safety and efficacy of testosterone 0.03% ophthalmic solution compared to vehicle for the treatment of meibomian gland dysfunction. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- testosterone ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Apr 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be ≥ 60 years of age
- Have a corrected visual acuity of LogMAR +0.5 (ETDRS)
- Have a documented history of Meibomian Gland Dysfunction
- Have a TFBUT ≤ 5 seconds
- Have an ocular discomfort score ≥ 1
- Have an IOP ≤ 25 mmHg at Visit 1 in both eyes
- Report use of and/or desire to use an artificial tears
Who cannot join
- Have contraindications to the use of the study medications
- Have a known allergy or sensitivity to the study medications
- Have any ocular infections, or active ocular inflammation
- Have used ocular medications within 24 hours prior to Visit 1
- Be a current contact lens wearer
- Require the use of any other ophthalmic medication, other than tear substitutes and study medication provided, for the duration of the trial
- Have used systemic or topical antihistamines or steroids 48 hours prior to Visit 1 or require the use of systemic or topical antihistamines or steroids during the course of the study
- Have a history of prostate cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Ophthalmic Research Associates
Andover, Massachusetts, 01810
About this study
Official title: A Single-Center, Double-Masked, Randomized, Vehicle Controlled Study to Evaluate the Safety and Efficacy of Testosterone 0.03% Ophthalmic Solution Compared to Vehicle for the Treatment of Meibomian Gland Dysfunction
The objective of this study is to assess the safety and efficacy of testosterone 0.03% ophthalmic solution compared to vehicle for the treatment of meibomian gland dysfunction.
Read the detailed description
Meibomian gland secretion plays a crucial role in the health of the ocular surface and function of the tear film. The lipid secreted by the meibomian glands has many crucial roles: 1) to retard evaporation from the preocular surface; 2) lower the surface tension of tears; 3) prevent spill-over of tears from the lid margin; 4) prevent the contamination of the tear film by sebaceous lipids; 5) prevent damage to the skin of the lid margin. In dry eye syndrome, blepharitis, meibomian gland dysfunction, and meibomitis the glands are the central pathophysiology of disease and thus a potential target for therapy.
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- testosterone ophthalmic solution, vehicle of testosterone ophthalmic solution
- Keywords
- Meibomian Gland Dysfunction, Dry Eye Syndrome
- Medical subject headings
- Meibomian Gland Dysfunction, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testosterone ophthalmic solutionDrug
testosterone ophthalmic solution for 128 days
vehicle of testosterone ophthalmic solutionDrug
vehicle of testosterone ophthalmic solution for 128 days
| Study group | Role | What they receive |
|---|---|---|
| testosterone ophthalmic solution | Experimental | testosterone ophthalmic solution 0.03% Receives: Drug: testosterone ophthalmic solution |
| vehicle | Placebo comparator | vehicle of testosterone ophthalmic solution Receives: Drug: vehicle of testosterone ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meibomian Gland Secretion Appearance at Visit 4 (Day 168)
The average of the secretion color, quality, and viscosity of the worst gland in the worst eye. All scales were numerical analog, 0-3, where 0=normal and 3=worst.
Measured: 168 days
Ocular Discomfort Score at Visit 4
Ocular Discomfort Score on a 0-4 scale where 0=none and 4=constant discomfort at Visit 4 (Day 168)
Measured: 168 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- ORA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- H. Jerome Crampton, MD, Principal investigator, ORA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755183
- Sponsor's protocol ID
- 08-004-16
- Status last verified
- Sep 2020
- First submitted
- 17 Sep 2008
- Last updated
- 22 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Double-Masked, Randomized, Vehicle Controlled Study to Evaluate the Safety and Efficacy of Testosterone 0.03% Ophthalmic Solution Compared to Vehicle for the Treatment of Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT00755183
- Acronym / sponsor ID
- 08-004-16
- Conditions
- Meibomian Gland Dysfunction
- Keywords
- Meibomian Gland Dysfunction, Dry Eye Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ORA, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 18 Sep 2008 (estimated)
- Results
- Posted 22 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the safety and efficacy of testosterone 0.03% ophthalmic solution compared to vehicle for the treatment of meibomian gland dysfunction.
Detailed description
Meibomian gland secretion plays a crucial role in the health of the ocular surface and function of the tear film. The lipid secreted by the meibomian glands has many crucial roles: 1) to retard evaporation from the preocular surface; 2) lower the surface tension of tears; 3) prevent spill-over of tears from the lid margin; 4) prevent the contamination of the tear film by sebaceous lipids; 5) prevent damage to the skin of the lid margin. In dry eye syndrome, blepharitis, meibomian gland dysfunction, and meibomitis the glands are the central pathophysiology of disease and thus a potential target for therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| testosterone ophthalmic solution | Experimental | Drug: testosterone ophthalmic solutiontestosterone ophthalmic solution 0.03% |
| vehicle | Placebo comparator | Drug: vehicle of testosterone ophthalmic solutionvehicle of testosterone ophthalmic solution |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be ≥ 60 years of age
- Have a corrected visual acuity of LogMAR +0.5 (ETDRS)
- Have a documented history of Meibomian Gland Dysfunction
- Have a TFBUT ≤ 5 seconds
- Have an ocular discomfort score ≥ 1
Key exclusion criteria (8 listed)
- Have contraindications to the use of the study medications
- Have a known allergy or sensitivity to the study medications
- Have any ocular infections, or active ocular inflammation
- Have used ocular medications within 24 hours prior to Visit 1
- Be a current contact lens wearer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| testosterone ophthalmic solutiontestosterone ophthalmic solution for 128 days | Drug | testosterone ophthalmic solution |
| vehicle of testosterone ophthalmic solutionvehicle of testosterone ophthalmic solution for 128 days | Drug | vehicle |
Primary outcome
Meibomian Gland Secretion Appearance at Visit 4 (Day 168)
Time frame: 168 days
The average of the secretion color, quality, and viscosity of the worst gland in the worst eye. All scales were numerical analog, 0-3, where 0=normal and 3=worst.
Ocular Discomfort Score at Visit 4
Time frame: 168 days
Ocular Discomfort Score on a 0-4 scale where 0=none and 4=constant discomfort at Visit 4 (Day 168)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H. Jerome Crampton, MD principal investigator
ORA, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing testosterone ophthalmic solution in people with Meibomian Gland Dysfunction, run by ORA, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meibomian Gland Secretion Appearance at Visit 4 (Day 168) (time frame: 168 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.