Status:
COMPLETED
A Study of ALTY-0501 for the Treatment of Dry Eye Administered 4 Times a Day for a 56 Day Period
Lead Sponsor:
Alacrity Biosciences, Inc.
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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;
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00439400
Start Date
February 1 2007
End Date
August 1 2007
Last Update
October 2 2007
Active Locations (1)
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1
Ophthalmic Research Associates
Andover, Massachusetts, United States, 01810