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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00439400
Recruitment Status : Completed
First Posted : February 23, 2007
Last Update Posted : October 2, 2007
Information provided by:
Alacrity Biosciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: doxycycline Drug: placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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
Study Start Date : February 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: A Drug: doxycycline
Placebo Comparator: B Drug: placebo

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00439400

United States, Massachusetts
Ophthalmic Research Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Alacrity Biosciences, Inc.

Additional Information: Identifier: NCT00439400     History of Changes
Other Study ID Numbers: 0600419
First Posted: February 23, 2007    Key Record Dates
Last Update Posted: October 2, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents