Back to resultsEfficacy, Tolerability, and Comfort of 0.3% Hypromellose Eyedrops in Patients Undergoing LASIK Surgery
Primary Purpose
Dry Eye
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Pre-LASIK 0.3% hypromellose
Post-LASIK 0.3% hypromellose
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring Post LASIK dry eye, Pre LASIK dry eye, Hypromellose
Eligibility Criteria
Inclusion Criteria:
- Age 21 - 35
- Both sexes
- Seeking LASIK surgery at the Refractive Surgery Centre
- Meeting all established criteria for appropriateness for LASIK established by the treating center
Exclusion Criteria:
- Any corneal pathology including scars, prior herpes keratitis, prior corneal transplant
- Any immuno-compromised state including cancer, HIV infection, Hepatitis B or C, or diabetes mellitus
- Requirement for any eye-drops for any reason (eg, dry eye or conjunctivitis) within 3 months from time of enrollment
- Anticipated refusal or inability to undergo planned post-operative visits or assessment
- Failure to meet all established criteria for appropriateness for LASIK
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pre-LASIK 0.3% hypromellose
Post-LASIK 0.3% hypromellose
Arm Description
Outcomes
Primary Outcome Measures
Ocular Comfort Level From Baseline to End of Study
Patients rated their ocular comfort on a scale of 0 to 10 on the following parameters: Burning sensation, foreign body sensation, itching, watering of eyes, dryness of eyes, and photophobia. A higher score indicated greater discomfort. A negative change score indicated improvement.
Secondary Outcome Measures
Tear Breakup Time From Baseline to End of Study
The time required for dry spots to appear on the corneal surface after blinking. Sodium fluorescein dye is added to the eye and the tear film is observed under a slit lamp while the patient avoids blinking until tiny dry spots develop. The longer it takes, the more stable the tear film. A short tear breakup time is a sign of a poor tear film. Generally, >10 seconds is thought to be normal, 5 to 10 seconds marginal, and <5 seconds low (with high likelihood of dry eye symptoms), ie, a shorter time indicates greater eye dryness. A positive change score indicates improvement.
Results of Schirmer's Test From Baseline to End of Study
Schirmer's test determines tear production, and whether the eye produces enough tears to keep it moist. A small strip of filter paper is inserted inside the lower eyelid of each eye and the eyes are closed for 5 minutes. The paper is then removed and the length of paper that is moist is measured. A young person normally moistens 15 mm of the paper. The shorter the length of moist paper, the dryer the eyes. A positive change score indicates improvement.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00909324
Brief Title
Efficacy, Tolerability, and Comfort of 0.3% Hypromellose Eyedrops in Patients Undergoing LASIK Surgery
Official Title
Efficacy, Tolerability and Comfort of 0.3% Hypromellose Eyedrops in the Pre- and Post-Operative Treatment of Patients Undergoing LASIK Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2009 (Actual)
Primary Completion Date
January 1, 2010 (Actual)
Study Completion Date
January 1, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
This study is designed to assess the tolerability and comfort of peri-operative 0.3% hypromellose eye drops in LASIK surgery patients and to assess whether pre-operative 0.3% hypromellose eye drops add to post-operative comfort in LASIK surgery patients compared to control (no pre-operative lubricant).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Post LASIK dry eye, Pre LASIK dry eye, Hypromellose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-LASIK 0.3% hypromellose
Arm Type
Experimental
Arm Title
Post-LASIK 0.3% hypromellose
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Pre-LASIK 0.3% hypromellose
Intervention Description
Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
Intervention Type
Drug
Intervention Name(s)
Post-LASIK 0.3% hypromellose
Intervention Description
Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
Primary Outcome Measure Information:
Title
Ocular Comfort Level From Baseline to End of Study
Description
Patients rated their ocular comfort on a scale of 0 to 10 on the following parameters: Burning sensation, foreign body sensation, itching, watering of eyes, dryness of eyes, and photophobia. A higher score indicated greater discomfort. A negative change score indicated improvement.
Time Frame
Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery
Secondary Outcome Measure Information:
Title
Tear Breakup Time From Baseline to End of Study
Description
The time required for dry spots to appear on the corneal surface after blinking. Sodium fluorescein dye is added to the eye and the tear film is observed under a slit lamp while the patient avoids blinking until tiny dry spots develop. The longer it takes, the more stable the tear film. A short tear breakup time is a sign of a poor tear film. Generally, >10 seconds is thought to be normal, 5 to 10 seconds marginal, and <5 seconds low (with high likelihood of dry eye symptoms), ie, a shorter time indicates greater eye dryness. A positive change score indicates improvement.
Time Frame
Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery
Title
Results of Schirmer's Test From Baseline to End of Study
Description
Schirmer's test determines tear production, and whether the eye produces enough tears to keep it moist. A small strip of filter paper is inserted inside the lower eyelid of each eye and the eyes are closed for 5 minutes. The paper is then removed and the length of paper that is moist is measured. A young person normally moistens 15 mm of the paper. The shorter the length of moist paper, the dryer the eyes. A positive change score indicates improvement.
Time Frame
Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 21 - 35
Both sexes
Seeking LASIK surgery at the Refractive Surgery Centre
Meeting all established criteria for appropriateness for LASIK established by the treating center
Exclusion Criteria:
Any corneal pathology including scars, prior herpes keratitis, prior corneal transplant
Any immuno-compromised state including cancer, HIV infection, Hepatitis B or C, or diabetes mellitus
Requirement for any eye-drops for any reason (eg, dry eye or conjunctivitis) within 3 months from time of enrollment
Anticipated refusal or inability to undergo planned post-operative visits or assessment
Failure to meet all established criteria for appropriateness for LASIK
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Novartis India Ltd.
Organizational Affiliation
Novartis India Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Delhi
ZIP/Postal Code
110088
Country
India
12. IPD Sharing Statement
Learn more about this trial
Efficacy, Tolerability, and Comfort of 0.3% Hypromellose Eyedrops in Patients Undergoing LASIK Surgery
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