Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye

• Carboxymethylcellulose and Glycerin based artificial tear (Drug): 1 to 2 drops into each eye as needed but at least twice daily
• Carboxymethylcellulose (Drug), also known as Refresh Plus: 1 to 2 drops into each eye as needed but at least twice daily

Primary outcomes

• Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score [Change from baseline at Day 30]: Ocular Surface Disease Index© Questionnaire Score is measured on 12 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity)

Secondary outcomes

• Change From Baseline at Day 30 in Schirmer Test, With Anesthesia [Change from baseline at Day 30]: Schirmer Test measures the rate of the secretion of tears
• Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein [Change from baseline at Day 30]: Measures the stability of tear film. The average of 3 measures.
• Patient Acceptability Score (Dryness) at Day 30 [Day 30]: Dryness Severity Visual Analog Scale is measured on a 0-100 point scale (0 = could not be worse, 100 = none at all).
• Patient Acceptability Score (Vision) at Day 30 [Day 30]: Vision Quality Visual Analog Scale is measured on a 0-100 point scale (0 = very poor, has never been worse, 100 = excellent, has never been better).
• Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein [Change from baseline at Day 30]: Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-25 (0= no staining, 25 = most severe staining)
• Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein [Change from baseline at Day 30]: Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-30 (0=no staining, 30=most severe staining)
• Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score [Change from baseline at Day 30]: Measures dry eye severity on a scale of 0-4 (0 = none, 4 = severe)

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Mild, moderate or Severe Symptoms of Dry Eye

Exclusion Criteria:

* Uncontrolled systemic disease
* Use of systemic medications affecting dry eye
* Pregnancy or planning a pregnancy
* Contact lens wear

Participant flow

Outcome results

• Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score (Primary), Mean, Units on a scale: Carboxymethylcellulose and Glycerin Based Artificial Tear 44 +/- 18.1; Carboxymethylcellulose Based Artificial Tear 45.2 +/- 18.3
• Change From Baseline at Day 30 in Schirmer Test, With Anesthesia (Secondary), Mean, mm/5min: Carboxymethylcellulose and Glycerin Based Artificial Tear 9.2 +/- 7.2; Carboxymethylcellulose Based Artificial Tear 8.6 +/- 6.8
• Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein (Secondary), Mean, seconds: Carboxymethylcellulose and Glycerin Based Artificial Tear 4.3 +/- 2.1; Carboxymethylcellulose Based Artificial Tear 4.3 +/- 2.0
• Patient Acceptability Score (Dryness) at Day 30 (Secondary), Mean, Units on scale: Carboxymethylcellulose and Glycerin Based Artificial Tear 47.4 +/- 22.8; Carboxymethylcellulose Based Artificial Tear 44.6 +/- 20.5
• Patient Acceptability Score (Vision) at Day 30 (Secondary), Mean, Units on a scale: Carboxymethylcellulose and Glycerin Based Artificial Tear 56.8 +/- 22.4; Carboxymethylcellulose Based Artificial Tear 54.2 +/- 21.6
• Vision Subscale of the Ocular Surface Disease Index Questionnaire© at Day 30 (Post hoc), Mean, Units on a scale: Carboxymethylcellulose and Glycerin Based Artificial Tear 37.6 +/- 21.5; Carboxymethylcellulose Based Artificial Tear 41.6 +/- 21.6
• Ocular Surface Staining With Fluorescein (Central Cornea) at Day 30 (Post hoc), Mean, Units on a scale: Carboxymethylcellulose and Glycerin Based Artificial Tear 0.7 +/- 0.8; Carboxymethylcellulose Based Artificial Tear 0.8 +/- 0.8
• Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein (Secondary), Mean, Units on a scale: Carboxymethylcellulose and Glycerin Based Artificial Tear 4.0 +/- 3.3; Carboxymethylcellulose Based Artificial Tear 4.4 +/- 3.4
• Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein (Secondary), Mean, Units on a scale: Carboxymethylcellulose and Glycerin Based Artificial Tear 4.9 +/- 4.4; Carboxymethylcellulose Based Artificial Tear 5.1 +/- 5.0
• Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score (Secondary), Mean, Units on a scale: Carboxymethylcellulose and Glycerin Based Artificial Tear 2.8 +/- 0.7; Carboxymethylcellulose Based Artificial Tear 2.8 +/- 0.8

Adverse events

Serious adverse events by term

• Medical Director, Study director, Allergan