Efficacy, Tolerability, and Comfort of 0.3% Hypromellose Eyedrops in Patients Undergoing LASIK Surgery

Efficacy, Tolerability and Comfort of 0.3% Hypromellose Eyedrops in the Pre- and Post-Operative Treatment of Patients Undergoing LASIK Surgery

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).

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Pre-LASIK 0.3% hypromellose; Drug: Post-LASIK 0.3% hypromellose

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Delhi, India, 110088
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 31 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-LASIK 0.3% hypromellose	Drug: Pre-LASIK 0.3% hypromellose; 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.
Active Comparator: Post-LASIK 0.3% hypromellose	Drug: Post-LASIK 0.3% hypromellose; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery
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.	Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis India Ltd., Novartis India Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: May 26, 2009
• First Submitted That Met QC Criteria: May 26, 2009
• First Posted (Estimate): May 28, 2009

Study Record Updates

• Last Update Posted (Actual): August 17, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Post LASIK dry eye; Pre LASIK dry eye; Hypromellose
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: CGET980AIN03