The benefits of artificial tears to relieve dry eye symptoms include, but are not limited
to: stabilizing the tear film layer, fluid supplement action, improving visual acuity, and
comfort. Studies have found a relationship between some of these benefits. For example,
stabilization of the tear film is important not only to increase the tear break up time
(TBUT), but is key in improving and maintaining visual acuity. These studies have alluded to
the fact that there may or may not be a relationship between residence time and visual
performance. Viscosity is one reason behind the uncertainty. Some solutions contain polymers
which influence the ocular surface when contacted. This can impact residence time and
ultimately visual performance. No prior research has explored the direct relationship
between residence time and visual performance.
Residence time refers to the duration at which the artificial tear resides on the eye.
Methods have been developed to assess residence time by admixing fluorescent tracers to the
solution and then measuring the amount of fluorescence over time. The caveat to methods
using certain tracers has lead to uncertainty in elimination measurements due to corneal
penetration or differing molecular weights (MW) from the active vehicle ingredient in the
solution. For example, low-MW tracers can be eliminated at a different rate than higher-MW
polymers. In addition, the low-MW tracers may be able to penetrate the corneal epithelium
giving a false pre-corneal residence time. Meadows, Paugh, Joshi, and Mordaunt addressed
this issue by developing a technique using a polymer which did not penetrate the cornea and
had the same MW as the active ingredient in the solution FITC-dextran. Based on the
assumption that similar weights are eliminated at the same rate, this technique has shown to
be more economic, manageable, and amendable than previous procedures measuring residence
Any ophthalmic drop has the potential to impact visual acuity upon instillation due to the
effect it has on the tear layer components. Studies have observed that taking artificial
tears continuously over time tends to stabilize the tear layer thus minimizing the immediate
drop in contrast sensitivity upon instillation. Measuring the visual effect of artificial
tears, using contrast sensitivity as a measure, provides valuable information about the
therapeutic effect of artificial tears that are meant to stabilize the tear film, thus
improving visual acuity in dry eye patients.
But what about the patient? There is a difference between residence time and retention of
effect- which is often what matters the most for patients. Retention of effect refers to the
beneficial effect of the drop. Currently there is no real measure of retention of effect.
Doctors can assess the tear film objectively, but there have been no strong correlations
between subjective dry symptoms and tear film stability. A possible reason for the lack of
correlation may be due to the fact that subjectivity is difficult to quantify. However,
scales like the Visual Analog Scale (VAS) and Numerical Rating Scale (NRS) have been
established in an attempt to quantify subjective experiences such as visual quality. We will
be using the NRS to gauge the comfort of the drop upon the initial application to get a
general idea of the comfort the drop provides to the user.
Although there have been several studies done on residence time and visual effect of
ophthalmic formulations separately, there is no current research correlating these two
aspects of therapeutic efficacy. This study will be the first to concurrently investigate
residence time (using FITC-dextran) and visual effect of an ophthalmic formulation.
- There are no requirements as to subject race, gender or occupation. All subjects
must meet the following criteria:
- The informed consent document must be read, signed and dated by the subject or
legally authorized representative before conducting any procedures.
Additionally, the informed consent document must be signed and dated by the
individual obtaining consent of the subject.
- Adult subjects, > age 18 years, with mild-to-moderate dry eye. Criteria for the
diagnosis must include two of the three following characteristics as
demonstrated at the Eligibility Visit:
- Composite symptom score of ≥ 7 on the Schein Questionnaire:
- Sodium Fluorescein (NaFl) Tear Break-Up Time ≤ 7 seconds in either (worse) eye
- Cumulative Sodium Fluorescein (NaFl) Corneal Staining ≥ 4 in either (worse) eye
on a 0-20 point scale (corresponds to ≥ 3 on a 0-15 scale).
- Able and willing to follow study instructions.
- Subjects must have best corrected visual acuity of 20/25 or better in each eye
as assessed using an ETDRS chart.
- Subjects demonstrating any medical condition that may affect the results of this
study will NOT be enrolled. The following are specific conditions that exclude
subjects from enrollment in this study.
- History or evidence of ocular or intraocular surgery in either eye within the
past six months. LASIK and other keratorefractive procedure patients can qualify
if the most recent surgery or enhancement was 12 or more months prior.
- History or evidence of serious ocular trauma in either eye within the past six
- History of hypersensitivity to any component of the study medications: History
of hypersensitivity to any component of Optive® Artificial Tears, Systane®
Artificial Tears, diagnostic dyes sodium fluorescein and fluorescein
- History or evidence of epithelial herpes simplex keratitis (dendritic
keratitis); vaccinia, active or recent varicella, viral disease of the cornea
and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva;
mycobacterial infection of the eye; and/or fungal disease of the eye.
- Use of concomitant topical ocular medications during the study period.
- Subjects using systemic steroids, immunosuppressive agents and/or
anti-cholinergics (e.g. cold and allergy medications, tricyclic antidepressants)
for treatment of autoimmune connective tissue disease may not be enrolled in the
study if they have not been on a stable dosing regimen for a minimum of 30 days
prior to the Eligibility Visit. In addition, the dosing regimen must remain
stable throughout the study period.
- Ocular conditions such as conjunctival infections, or iritis.
- Individuals unwilling to discontinue contact lens wear for 2 days prior to each
visit during the study period.
- Participation in an investigational drug or device study within 30 days of
entering this study.