A Study of ALTY-0501 for the Treatment of Dry Eye Administered 4 Times a Day for a 56 Day Period

Completed · Phase 2 · Has a placebo group

Conditions studied: Dry Eye

In brief

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.

Key facts

Study ID

NCT00439400

Run by

Alacrity Biosciences, Inc.

People needed

160

Starts

2007-02-01

Expected to finish

2007-08-01

Last updated by the study team

2007-10-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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.

Where it is running

• Ophthalmic Research Associates — Andover, Massachusetts, United States

Full record on ClinicalTrials.gov

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