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

NCT00439400 | Completed Phase 2

• 1 other identifier: 0600419
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: doxycycline

B

PLACEBO COMPARATOR

Drug: placebo

Interventions

doxycycline DRUG

A

placebo DRUG

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Alacrity Biosciences, Inc.: lead

Study Sites (1)

Ophthalmic Research Associates

Andover, Massachusetts, 01810, United States

Location

Related Links

• Alacrity Biosciences Web page
• Ophthalmic Research Associates web page

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 22, 2007
• First Posted: February 23, 2007
• Study Start: February 1, 2007
• Study Completion: August 1, 2007
• Last Updated: October 2, 2007

Record last verified: 2007-10

Locations

US (1)