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A Study to Compare a New Eye Drop Formulation With Systane® Gel Drops and Genteal® Lubricant Gel Drops for Moderate to Severe Dry Eye Relief

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ClinicalTrials.gov Identifier: NCT02455050
Recruitment Status : Completed
First Posted : May 27, 2015
Results First Posted : January 4, 2017
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
A study to evaluate the tolerability and acceptability of an investigational eye drop formulation in patients with Dry Eye Disease.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: Carboxymethylcellulose Sodium Based Eye Drops Drug: Systane® Gel Drops Drug: Genteal® Lubricant Gel Drops Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : December 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015


Arm Intervention/treatment
New Eye Drop Formulation then Systane®
1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks.
Drug: Carboxymethylcellulose Sodium Based Eye Drops
1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops [New Eye Drop Formula] in each eye.

Drug: Systane® Gel Drops
1 to 2 drops of Systane® Gel Drops in each eye.
Other Name: 1 to 2 drops of Systane® Gel Drops in each eye daily.

Systane® then New Eye Drop Formulation
1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks.
Drug: Carboxymethylcellulose Sodium Based Eye Drops
1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops [New Eye Drop Formula] in each eye.

Drug: Systane® Gel Drops
1 to 2 drops of Systane® Gel Drops in each eye.
Other Name: 1 to 2 drops of Systane® Gel Drops in each eye daily.

Genteal® then New Eye Drop Formulation
1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks.
Drug: Carboxymethylcellulose Sodium Based Eye Drops
1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops [New Eye Drop Formula] in each eye.

Drug: Genteal® Lubricant Gel Drops
1 to 2 drops of Genteal® Lubricant Gel Drops in each eye.

New Eye Drop Formulation then Genteal®
1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks.
Drug: Carboxymethylcellulose Sodium Based Eye Drops
1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops [New Eye Drop Formula] in each eye.

Drug: Genteal® Lubricant Gel Drops
1 to 2 drops of Genteal® Lubricant Gel Drops in each eye.




Primary Outcome Measures :
  1. Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1 [ Time Frame: After 14 days of treatment in Period 1 (Follow-up 1 Day 14) ]
    Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst).

  2. Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 2 [ Time Frame: After 14 days of treatment in Period 2 (Follow-up 2 Day 35) ]
    Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst).


Secondary Outcome Measures :
  1. Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 1 [ Time Frame: Baseline and after 14 days of treatment in Period 1 (Follow-up 1 Day 14) ]
    The OSDI Questionnaire consisted of 12 questions: ocular symptoms (sensitive to light, feel gritty, painful or sore), vision-related functions (blurred vision, poor vision, reading, driving at night, working on a computer and watching TV) and environmental triggers (windy conditions, low humidity/dry areas and air-conditioned areas). Participants were asked to base their evaluation on the frequency of their symptoms over the last week, using a 5-point scale: 0=none of the time to 4=all of time. The total score is converted to a 0 to 100 score where 0 is best and 100 is worst.

  2. Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 2 [ Time Frame: Baseline and after 14 days of treatment in Period 2 (Follow-up 2 Day 35) ]
    The OSDI Questionnaire consisted of 12 questions: ocular symptoms (sensitive to light, feel gritty, painful or sore), vision-related functions (blurred vision, poor vision, reading, driving at night, working on a computer and watching TV) and environmental triggers (windy conditions, low humidity/dry areas and air-conditioned areas). Participants were asked to base their evaluation on the frequency of their symptoms over the last week, using a 5-point scale: 0=none of the time to 4=all of time. The total score is converted to a 0 to 100 score where 0 is best and 100 is worst.

  3. Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 [ Time Frame: After 14 days of treatment in Period 1 (Follow-up 1 Day 14) ]
    Acceptability Survey is comprised of 8 questions (Q): Q1-effective dry-eye relief, Q2-eyes feel comfortable, Q3-vision did not blur, Q4-vision normal within 10 minutes, Q5-substantial feel/optimally thick, Q6-eyelashes not matted/crusty, Q7- satisfied overall and Q8-switch to this product/if my doctor recommended. The participant answered the questions using the following scale: a=strongly agree, b=agree, c=neither agree nor disagree, d=disagree and e=strongly disagree. The percentage of participants who selected Strongly Agree or Agree is reported.

  4. Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 [ Time Frame: After 14 days of treatment in Period 2 (Follow-up 2 Day 35) ]
    Acceptability Survey is comprised of 8 questions (Q): Q1-effective dry-eye relief, Q2-eyes feel comfortable, Q3-vision did not blur, Q4-vision normal within 10 minutes, Q5-substantial feel/optimally thick, Q6-eyelashes not matted/crusty, Q7- satisfied overall and Q8-switch to this product/if my doctor recommended. The participant answered the questions using the following scale: a=strongly agree, b=agree, c=neither agree nor disagree, d=disagree and e=strongly disagree. The percentage of participants who selected Strongly Agree or Agree is reported.

  5. Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 1 [ Time Frame: Baseline and After 14 days of treatment in Period 1 (Follow-up 1 Day 14) ]
    SESoD assessed the severity of dryness (defined as discomfort/irritation due to dry feeling in the eye) evaluated by the participant on a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate and 4=severe (always notice the symptom and interferes with activities).

  6. Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 2 [ Time Frame: Baseline and After 14 days of treatment in Period 2 (Follow-up 2 Day 35) ]
    SESoD assessed the severity of dryness (defined as discomfort/irritation due to dry feeling in the eye) evaluated by the participant on a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate and 4=severe (always notice the symptom and interferes with activities).

  7. Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®) [ Time Frame: Day 35 ]
    End of Study Survey consisted of 4 questions assessing product preference: Q1-overall comfort, Q2-symptom relief, Q3-less blurring and Q4-preference/willingness to purchase the product. The participant answered each questions using the scale: a=first product better, b=second product better or c=equal. The percentage of participants in each response category is reported.

  8. Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®) [ Time Frame: Day 35 ]
    End of Study Survey consisted of 4 questions assessing product preference: Q1-overall comfort, Q2-symptom relief, Q3-less blurring and Q4-preference/willingness to purchase the product. The participant answered each questions using the scale: a=first product better, b=second product better or c=equal. The percentage of participants in each response category is reported.

  9. Distance Visual Acuity in Period 1 [ Time Frame: After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation ]
    Distance visual acuity is measured in each eye at 5 and 30 minutes post drop instillation using an eye chart at 4 meters and is reported as the number of letters read correctly (ranging from 0 to 100 letters).

  10. Distance Visual Acuity in Period 2 [ Time Frame: After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation ]
    Distance visual acuity is measured in each eye at 5 and 30 minutes post drop instillation using an eye chart at 4 meters and is reported as the number of letters read correctly (ranging from 0 to 100 letters).

  11. Tear Break-Up Time With Fluorescein in Period 1 [ Time Frame: After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation ]
    Fluorescein was applied to the eyes and three consecutive TBUTs are performed in each eye at 5 and 30 minutes post drop instillation. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.

  12. Tear Break-Up Time With Fluorescein in Period 2 [ Time Frame: After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation ]
    Fluorescein was applied to the eyes and three consecutive TBUTs are performed in each eye at 5 and 30 minutes post drop instillation. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.

  13. Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 [ Time Frame: After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation ]
    Participants completed the 4 question Eye Drop Experience Survey at 5 and 30 minutes post drop instillation: Question (Q) 1-vision clear/without blur, Q2-drops soothing/comfortable, Q3-drops relieve dry eye symptoms and Q4-comfortable/soothing. Q1 to Q3 were answered using a 5-point scale: 1=strongly disagree to 5=strongly agree. Q4 is answered using a Labeled Hedonic scale by placing a mark on a vertical line where the bottom of the line -100=most uncomfortable/irritating imaginable, middle of the line=neutral to top of the line 100=most comfortable/soothing imaginable.

  14. Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 [ Time Frame: After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation ]
    Participants completed the 4 question Eye Drop Experience Survey at 5 and 30 minutes post drop instillation: Question (Q) 1-vision clear/without blur, Q2-drops soothing/comfortable, Q3-drops relieve dry eye symptoms and Q4-comfortable/soothing. Q1 to Q3 were answered using a 5-point scale: 1=strongly disagree to 5=strongly agree. Q4 is answered using a Labeled Hedonic scale by placing a mark on a vertical line where the bottom of the line -100=most uncomfortable/irritating imaginable, middle of the line=neutral to top of the line 100=most comfortable/soothing imaginable.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current use of an artificial tear product
  • Visual Acuity of at least 20/40 (while wearing glasses, if necessary).

Exclusion Criteria:

  • Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
  • Cataract surgery, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy within 6 months
  • Use of RESTASIS® Cyclosporine Ophthalmic Emulsion or any topical cyclosporine within 3 months
  • Diagnosis of glaucoma.

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 ClinicalTrials.gov identifier (NCT number): NCT02455050


Locations
United States, California
Azusa, California, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02455050     History of Changes
Obsolete Identifiers: NCT02343900
Other Study ID Numbers: 11193X-002
First Posted: May 27, 2015    Key Record Dates
Results First Posted: January 4, 2017
Last Update Posted: January 4, 2017
Last Verified: November 2016

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Tetrahydrozoline
Carboxymethylcellulose Sodium
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Laxatives
Gastrointestinal Agents