Dry EyePhase 2NCT00439400
A Study of ALTY-0501 for the Treatment of Dry Eye Administered 4 Times a Day for a 56 Day Period
A Phase 2 study testing doxycycline in people with Dry Eye, run by Alacrity Biosciences, Inc. at 1 site in United States.
Trial summary
The objective of this study is to assess the safety and efficacy of doxycycline 0.025% (ALTY-0501) ophthalmic solution for the treatment of dry eye using the Controlled Adverse Environment (CAE) Model. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- doxycycline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Aug 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Are 18 years of age or older;
- Are able and willing to follow instructions, including participation in study assessments, and can be present for the required study visits for the duration of the study;
- Have a diagnosis of dry eye associated with meibomian gland disease; A fluorescein staining staining score of ≥ 1+ in at least one region of the cornea; Presence of eyelid telangiectasia and/or inspissation or metaplasia of meibomian gland orifices; An ocular dryness score of ≥1+;
- Have a TFBUT ≤ 7 seconds in at least one eye at Visit 1;
- Have a best corrected visual acuity (BCVA) of +0.7 or better assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit 1;
- (If female and of childbearing potential) Are not pregnant, nursing, or planning a pregnancy. Women of childbearing potential are required to have a negative urine pregnancy test at the screening and exit visits and agree to use an acceptable method of contraception for the duration of the study;
Who cannot join
- Have anterior blepharitis, which is deemed clinically significant and/or likely to interfere with study parameters in the opinion of the investigator;
- Are diagnosed with an on-going ocular infection (bacterial, viral, or fungal), or active ocular inflammation (e.g., follicular conjunctivitis);
- Report an ocular discomfort score of 4 in both eyes at time 0 of CAE exposure at Visit 2;
- Wear contact lenses within 1 week of Visit 1 or throughout the course of the study;
- Have contact lens-induced dry eye;
- Have previously had laser in situ keratomileusis (LASIK) surgery;
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- Are currently taking any topical ophthalmic prescription or over-the-counter (OTC) solutions, artificial tears, gels or scrubs and cannot discontinue these medications for the duration of the trial;
- Have used Restasis® within 30 days of Visit 1;
- Have used any eye drops within 2 hours of Visit 1;
- Any eye drop containing BAK as a preservative for 1 week prior to study start;
- Have a systemic disease, or uncontrolled medical condition, that in the opinion of the investigator could interfere with study measurements or subject compliance;
- Are currently taking (at Visit 1) any medication known to cause ocular drying that has not been used on a stable dosing regimen for 30 days prior to Visit 1;
- Are currently pregnant, nursing, or planning a pregnancy;
- (For women of childbearing potential) Be unwilling to submit a urine sample for a pregnancy test at Visit 1 and at exit visit;
- Have received another experimental drug or device within 30 days of visit 1.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ophthalmic Research Associates
Andover, Massachusetts, 01810
About this study
Official title: A Double-Masked, Randomized, Placebo-Controlled Study of ALTY-0501 (Doxycycline 0.025% Ophthalmic Solution) for the Treatment of Dry Eye Administered QID for a 56 Day Period Utilizing the Controlled Adverse Environment Model
The objective of this study is to assess the safety and efficacy of doxycycline 0.025% (ALTY-0501) ophthalmic solution for the treatment of dry eye using the Controlled Adverse Environment (CAE) Model.
Read the detailed description
Dry eye is the most prevalent form of ocular discomfort and irritation. Estimates range up to 20 million people in the US being affected with mild dry eye, and the literature reports that as many as 3.2 million American women suffer from clinically significant dry eye.(Schaumberg et al, 2003). Dry eye can be related to external factors, such as the low humidity of air conditioned offices, winter heating, a dusty or windy outdoor environment, prolonged use of computers, or wearing of contact lenses, as well as to internal factors, such as hormonal imbalance, autoimmune disease, the presence of many widely prescribed systemic medications, anatomical changes or trauma, and aging. Chronic dry eye disease is associated with an immune-based inflammation of the lacrimal glands and the ocular surface. Symptoms result in mildly decreased quality of life at a minimum, and with increasing severity, loss of function and productivity, pain, light sensitivity, and the misery that accompanies significantly impaired vision and decreased quality of life. With the aging population in the United States and other countries of the developed world, and with increasing computer use, dry eye will become more prevalent.
Doxycycline is a well established anti-infective drug, and has been used systemically by ophthalmologists to treat moderate to severe case of blepharitis for years. Recently it has been demonstrated that doxycycline in low, non-antimicrobial concentrations also has powerful anti-proteolytic and anti-inflammatory properties. Anecdotal reports on the use of 0.025% doxycyline eyedrops in human patients with dry eye and/or meibomian gland disease indicate a significant improvement in ocular surface staining and a significant decrease in patient symptoms.
- Conditions
- Dry Eye
- Being tested
- doxycycline, placebo
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxycyclineDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: doxycycline |
| B | Placebo comparator | Not described Receives: Drug: placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2007 (estimated)
- Study startFeb 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alacrity Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439400
- Sponsor's protocol ID
- 0600419
- Status last verified
- Oct 2007
- First submitted
- 22 Feb 2007
- Last updated
- 2 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Masked, Randomized, Placebo-Controlled Study of ALTY-0501 (Doxycycline 0.025% Ophthalmic Solution) for the Treatment of Dry Eye Administered QID for a 56 Day Period Utilizing the Controlled Adverse Environment Model
- ClinicalTrials.gov ID
- NCT00439400
- Acronym / sponsor ID
- 0600419
- Conditions
- Dry Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Alacrity Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2007
- Study completion
- Aug 2007 (actual)
- First posted
- 23 Feb 2007 (estimated)
- Results
- Not posted in the source record
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 doxycycline 0.025% (ALTY-0501) ophthalmic solution for the treatment of dry eye using the Controlled Adverse Environment (CAE) Model.
Detailed description
Dry eye is the most prevalent form of ocular discomfort and irritation. Estimates range up to 20 million people in the US being affected with mild dry eye, and the literature reports that as many as 3.2 million American women suffer from clinically significant dry eye.(Schaumberg et al, 2003). Dry eye can be related to external factors, such as the low humidity of air conditioned offices, winter heating, a dusty or windy outdoor environment, prolonged use of computers, or wearing of contact lenses, as well as to internal factors, such as hormonal imbalance, autoimmune disease, the presence of many widely prescribed systemic medications, anatomical changes or trauma, and aging. Chronic dry eye disease is associated with an immune-based inflammation of the lacrimal glands and the ocular surface. Symptoms result in mildly decreased quality of life at a minimum, and with increasing severity, loss of function and productivity, pain, light sensitivity, and the misery that accompanies significantly impaired vision and decreased quality of life. With the aging population in the United States and other countries of the developed world, and with increasing computer use, dry eye will become more prevalent.
Doxycycline is a well established anti-infective drug, and has been used systemically by ophthalmologists to treat moderate to severe case of blepharitis for years. Recently it has been demonstrated that doxycycline in low, non-antimicrobial concentrations also has powerful anti-proteolytic and anti-inflammatory properties. Anecdotal reports on the use of 0.025% doxycyline eyedrops in human patients with dry eye and/or meibomian gland disease indicate a significant improvement in ocular surface staining and a significant decrease in patient symptoms.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: doxycycline |
| B | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are 18 years of age or older;
- Are able and willing to follow instructions, including participation in study assessments, and can be present for the required study visits for the duration of the study;
- Have a diagnosis of dry eye associated with meibomian gland disease; A fluorescein staining staining score of ≥ 1+ in at least one region of the cornea; Presence of eyelid telangiectasia and/or inspissation or metaplasia of meibomian gland orifices; An ocular dryness score of ≥1+;
- Have a TFBUT ≤ 7 seconds in at least one eye at Visit 1;
- Have a best corrected visual acuity (BCVA) of +0.7 or better assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit 1;
Key exclusion criteria (15 listed)
- Have anterior blepharitis, which is deemed clinically significant and/or likely to interfere with study parameters in the opinion of the investigator;
- Are diagnosed with an on-going ocular infection (bacterial, viral, or fungal), or active ocular inflammation (e.g., follicular conjunctivitis);
- Report an ocular discomfort score of 4 in both eyes at time 0 of CAE exposure at Visit 2;
- Wear contact lenses within 1 week of Visit 1 or throughout the course of the study;
- Have contact lens-induced dry eye;
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 |
|---|---|---|
| doxycycline | Drug | A |
| placebo | Drug | B |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2007.
- Alacrity Biosciences Web pageLink provided by the sponsor.
- Ophthalmic Research Associates web pageLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 doxycycline in people with Dry Eye, run by Alacrity Biosciences, 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 6 inclusion and 15 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 2 Oct 2007. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 2 Oct 2007.